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• Testosterone Therapy for Late-Onset Hypogonadism: A Clinical, Biological, and Analytical Approach Using Compounded Testosterone 0.5–20% Topical Gels Pharmaceutics
  Abstract
  Abstract: Testosterone is integral to men’s sexual and overall health, but there is a gradual decline in the ageing male. The topical administration of testosterone is a valuable option as a supplement (replacement) therapy to alleviate hypogonadal symptoms. The clinical efficacy of a compounded testosterone 5% topical gel was assessed retrospectively in a male patient in his seventies by evaluating the laboratory testing of the serum total testosterone and the results of a validated androgen deficiency questionnaire. After treatment, the patient’s hypogonadal symptoms improved and the serum total testosterone level achieved was considered clinically optimal. The skin permeation of the testosterone topical gel (biological testing) was evaluated in vitro using the Franz finite dose model and human cadaver skin, and it is shown that testosterone can penetrate into and through ex vivo human skin. Testosterone therapy is often prescribed for extended periods, and consequently, it is crucial to determine the beyond-use date of the compounded formulations. The analytical testing involved a valid, stability-indicating assay method for compounded testosterone 0.5% and 20% topical gels. This multidisciplinary study shows evidence supporting topically applied testosterone’s clinical efficacy and the compounded formulations’ extended stability. Personalized, topical testosterone therapy is a promising alternative in current therapeutics for hypogonadal patients.

• Case Study: Testosterone Replacement Therapy in Hypogonadism

• 595. In vitro Evaluation of Skin Distribution and Human Dermal Papilla Cells Proliferation for Minoxidil 5% Topical Lotion Hydrogel Journal of Investigative Dermatology

• Evaluation of Minoxidil 5% Topical Lotion Hydrogel on the Proliferation of Human Hair Dermal Papilla Cells In Vitro

• In Vitro Evaluation of Skin Distribution and Human Dermal Papilla Cells Proliferation for Minoxidil 5% Topical Lotion Hydrogel 2022 SID Meeting

• Integrated In Vivo and In Vitro Evaluation of a Powder-to-Hydrogel, Film-Forming Polymer Complex Base with Tissue-Protective and Microbiome-Supportive Properties Gels
  Abstract
  Abstract: The study aimed to perform a comprehensive in vitro and in vivo evaluation of a newly developed, patent-pending, powder-to-hydrogel, film-forming polymer complex base, which possesses tissue-protective and microbiome-supportive properties, and to compare its characteristics with poloxamer 407. The study used a combination of in vitro assays, including tissue viability and cell migration, and in vivo wound healing evaluations in male diabetic mice. Microbiome dynamics at wound sites were also analyzed. The in vitro assays demonstrated that the polymer complex base was non-cytotoxic and that it enhanced cell migration over poloxamer 407. In vivo, the polymer complex base demonstrated superior wound healing capabilities, particularly in combination with misoprostol and phenytoin, as evidenced by the reduced wound area and inflammation scores. Microbiome analysis revealed favorable shifts in bacterial populations associated with the polymer complex base-treated wounds. The polymer complex base demonstrates clinical significance in wound care, potentially offering improved healing, safety and microbiome support. Its transformative properties and efficacy in drug delivery make it a promising candidate for advanced wound care applications, particularly in chronic wound management.

• Science Manual 2024

• Case Studies Manual 2024

• In Vitro and In Vivo Evaluation of Wound Healing by Phenytoin 2% and Misoprostol 0.0024% Topical Hydrogel 2024 Societies for Investigative Dermatology (SID) Annual Meeting

• 666. In Vitro and In Vivo Evaluation of Wound Healing by Phenytoin 2% and Misoprostol 0.0024% Topical Hydrogel Journal of Investigative Dermatology
  Abstract
  Abstract: Chronic wounds are a major clinical problem that leads to considerable morbidity and mortality worldwide. A newly developed wound care compounding base was incorporated phenytoin 2% and misoprostol 0.0024% for in vitro and in vivo testing. The performance of this formulation was compared to a product of reference: phenytoin 2% and misoprostol 0.0024% in poloxamer gel, commonly used in wound healing. The process of re-epithelialization in vitro was evaluated using primary human keratinocytes and the Oris™ cell migration assay kit. The cells were treated with test formulations for 24 hours and then stained with Calcein AM. The process of wound healing in vivo was evaluated using the diabetic mice wound healing model (BKS-db), including 12 male mice distributed in a control group and two test groups (topical hydrogel and poloxamer formulations). Two full-thickness excisional skin wounds were made to the back of each mouse and the test formulations were applied daily on the skin wounds for a total of 9 days. Ethics approval was obtained for this animal study. Keratinocyte migration showed a mean change of 70.62% ± 43.27 (p=6.95E-06) from control for the topical hydrogel formulation, as opposed to -29.99% ± 22.85 (p=0.0007) for the poloxamer gel formulation. Keratinocyte migration is part of the re-epithelialization process in wound healing and, therefore, the topical hydrogel formulation is likely to have greater wound healing abilities than the product of reference. The mice were successfully treated for 9 days, as shown by the digital photographs of the wound areas. The mean percentage of relative wound area was lower for the topical hydrogel formulation (49.67%), when compared to the poloxamer gel formulation (71.54%) and the control group (75.44%), which reinforces the superior wound healing abilities of the topical hydrogel formulation. The authors are affiliated with Professional Compounding Centers of America (PCCA), the manufacturer of the newly developed wound care compounding base.

• Topical/Vaginal Treatment of Sexual Function Disorders
• Vulvovaginal Symptoms in a Postmenopausal Woman: Case Study International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: A postmenopausal female patient was suffering from vulvovaginal symptoms such as dryness and irritation, which were affecting her relationship with her partner and her overall quality of life. The patient was instructed to apply an estriol 0.1% vaginal ointment (PCCA Ellage Anhydrous Vaginal) for a duration of three months. The safety and efficacy of the compounded treatment were evaluated using an online data collection form, which included the validated Vulvovaginal Symptom Questionnaire. Post-treatment results show that the vulvovaginal symptoms were no longer bothersome, and that the patient’s relationship was no longer affected. There were no reports of undesirable effects as a result of the compounded treatment. This case study reinforces the benefits and convenience of using topical hormone replacement therapy in postmenopausal women.

• Effect of Ellage and Other PCCA Proprietary Bases on the pH of Vaginal Fluid
• Evaluation of the Irritation Potential of PCCA Ellage™ Anhydrous Vaginal Part 1: Hen’s Egg Test-Chorioallantoic Membrane Assay
• Evaluation of the Irritation Potential of PCCA Ellage™ Anhydrous Vaginal Part 2: Safety and Toxicological Profile by the MTT Assay
• Evaluation of the Self-Emulsifying Properties of PCCA Ellage™ Part 1: Microscopic Evaluation
• Evaluation of the Self-Emulsifying Properties of PCCA Ellage™ Part 2: Fluorescence Microscopy
• Evaluation of the Mucoadhesive Properties of PCCA Ellage™ Part 1: Ex Vivo Bioadhesion Testing Using a Texture Analyzer
• Evaluation of the Mucoadhesive Properties of PCCA Ellage™ Part 2: Ex Vivo Testing on Animal Vaginal Tissues
• In Vitro Drug Release of Estriol 0.1% and Testosterone 0.1% from VersaBase Cream and PCCA Ellage Anhydrous Vaginal
• In Vitro Drug Release of Amitriptyline 2% and Baclofen 2% from VersaBase Cream and PCCA Ellage Anhydrous Vaginal
• The Leakage Test: Evaluation of the Leakage Potential of PCCA Ellage™

• Development of a Mucoadhesive, Anhydrous and Self-Emulsifying Vaginal Base for Compounded Medications 12th PBP World Meeting (Virtual)

In-Vitro Studies

Dermatology

Pain Management

Stability Studies

Veterinary

Women's Health

Non-Categorized

• Evaluation of the Percutaneous Absorption of Promethazine Hydrochloride, In Vitro, Using the Human Ex Vivo Skin Model International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: For several years, pharmacists have been using vehicles such as Pluronic lecithin organogel and Lipoderm for the delivery of medication, including promethazine, through the skin. This study evaluated the percutaneous absorption pharmacokinetics of promethazine hydrochloride 25 mg/g in Pluronic lecithin organogel and the commercial base Lipoderm, in vitro, in human ex vivo skin, using the finite dose technique and Franz Diffusion Cells. Due to the polar nature of promethazine hydrochloride, it was theorized that this drug would present a transdermal challenge for these two commonly utilized compounding bases. An amount of 5 mcL/cm2 of each formulation was applied to triplicate sections of skin from three different ex vivo skin donors. At 4, 8, 12, 24, 32, and 48 hours post-application, the reservoir solution in the Franz Cell was removed and analyzed. Lipoderm performed better than Pluronic lecithin organogel based on total absorption into the reservoir solution (2.86% ± 0.79 vs. 1.73% ± 0.85) (P <0.2). Total
• Evaluation of Transdermal Drug Permeation as Modulated by Lipoderm and Pluronic Lecithin Organogel Journal of Pharmaceutical Sciences  Journal of Pharmaceutical Sciences
• In Vitro Characterization of the Percutaneous Absorption of Lorazepam into Human Cadaver Torso Skin, Using the Franz Skin Finite Dose Models Journal of Pharmaceutics and Drug Delivery Research
  Abstract
  Objective: Lorazepam is a sedative that may be used for the management of anxiety, insomnia, and chemotherapy-induced nausea and vomiting. Lorazepam can be incorporated into transdermal bases such as Lipoderm, referred to as Phospholipid Base, for drug delivery across the skin. The purpose of this study is to characterize the percutaneous absorption of lorazepam 5 mg/g in Phospholipid Base, when applied to human cadaver torso skin, in vitro, using the Franz skin finite dose model.
  
  Methods: The percutaneous absorption of lorazepam was evaluated using ex vivo human cadaver torso skin from 3 donors. The skin from each donor was cut into small sections to fit on nominal 2 cm2 Franz diffusion cells. A nominal volume equivalent to 5 mg formulation/cm2/skin section was then applied to a 2 cm2 dosing surface of 3 replicate skin sections for each donor. At predetermined time points (0, 2, 4, 8, 12, 24, 32, and 48 hr), the receptor solution within each chamber was removed, replaced with fresh receptor solution, and an aliquot of 6 mL was saved for analysis. Mean values for lorazepam total absorption, rate of absorption, skin content, and surface wash were quantified via HPLC analysis.
  
  Results: Lorazepam mean total absorption was 8.38% ± 4.37, with a rise to peak rate of absorption at approximately 30 hr following dose application. Lorazepam was also found within the dermis and epidermis at 0.22% ± 0.02 and 3.65% ± 1.29 of the applied dose, respectively.
  
  Conclusion: Results show that Phospholipid Base can facilitate the percutaneous absorption of lorazepam. This study’s findings may be helpful when justifying the viability of using Phospholipid Base as a vehicle for the transdermal delivery of lorazepam and could potentially be useful for practitioners and pharmacists considering the skin as an alternative route for the delivery of lorazepam.
   
• Mycophenolic Acid for Topical Immunosuppression in Vascularized Composite Allotransplantation: Optimizing Formulation and Preliminary Evaluation of Bioavailability and Pharmacokinetics Frontiers in Surgery
• Penetration Enhancement of Topical Formulations Pharmaceutics
• Novel Use of Patch Testing in the First Report of Allergic Contact Dermatitis to Cyclobenzaprine Dermatitis
• A randomized, double-blind, controlled study evaluating the effects of two facial serums on skin aging Skin Research & Technology
  Abstract
  Background: Skin aging is a natural process that occurs because of oxidative stress. Facial skin aging is often concerning for individuals due to the exposure of the face.
  
  Objectives: To assess and compare the effects of two anti-aging facial serums on the following characteristics associated with facial skin aging: fine lines/wrinkles, age spots, firmness, elasticity, texture, radiance, tone, lifting, clarity, and complexion.
  
  Methods: A 24-week, double-blind controlled study was conducted on 130 participants who were randomized into two groups: facial serum with Liposomal Blend and facial serum without Liposomal Blend. Clinical evaluations (Visual Analog Scale) and instrumental evaluations (Cutometer, SIAscope, and Clarity Pro image analysis) were performed at weeks 0 (baseline), 2, 4, 8, 12, and 24 to assess for changes in skin aging characteristics.
  
  Results: A total of 123 participants completed the study; participants that used the facial serum with Liposomal Blend had significantly greater improvements in skin aging characteristics compared to those that used the facial serum without Liposomal Blend. This study shows that Liposomal Blend is a vehicle with the ability to enhance the anti-aging properties of the ingredients within the facial serum by facilitating its delivery into the underlying layers of the skin. Higher concentration of ingredients at the site of action could potentially lead to greater damage repair and improvements in signs of facial skin aging.
  
  Conclusion: By using Liposomal Blend, practitioners and pharmacists could potentially improve the delivery of the ingredients within their formulations into the skin, which may lead to increased treatment efficacy.
• Analgesic Efficacy and Transdermal Penetration of Topical Gabapentin Creams: Finding an Optimal Dose and Pre-treatment Time International Journal of Pharmaceutical Compounding
• Evaluation of the Percutaneous Absorption of Ketamine HCl, Gabapentin, Clonidine HCl, and Baclofen, in Compounded Transdermal Pain Formulations, Using the Franz Finite Dose Model  Pain Medicine
  Abstract
  Objective: This study evaluates the ability of four commonly used analgesics (ketamine HCl, gabapentin, clonidine HCl, and baclofen), when incorporated into two transdermal compounding bases, Lipoderm and Lipoderm ActiveMax, to penetrate human cadaver trunk skin in vitro , using the Franz finite dose model.
  
  Design: In vitro experimental study.
  
  Methods: Ketamine HCl 5% w/w, gabapentin 10% w/w, clonidine HCl 0.2% w/w, and baclofen 2% w/w were compounded into two transdermal bases, Lipoderm and Lipoderm ActiveMax. Each compounded drug formulation was tested on skin from three different donors and three replicate skin sections per donor. The Franz finite dose model was used in this study to evaluate the percutaneous absorption and distribution of drugs within each formulation.
  
  Results: Rapid penetration to peak flux was detected for gabapentin and baclofen at approximately 1 hour after application. Clonidine HCl also had a rapid penetration to peak flux occurring approximately 1 hour after application and had a secondary peak at approximately 40 hours. Ketamine HCl exhibited higher overall absorption rates than the other drugs, and peaked at 6–10 hours. Similar patterns of drug distribution within the skin were also observed using both transdermal bases.
  
  Conclusion: This study suggests that the combination of these 4 analgesic drugs can be successfully delivered transdermally, using either Lipoderm or Lipoderm ActiveMax. Compounded transdermal drug preparations may then provide physicians with an alternative to traditional oral pain management regimens that can be personalized to the specific patient with the potential for enhanced pain control.
• Benzocaine 20%, Lidocaine 6%, and Tetracaine 4% in Lipoderm International Journal of Pharmaceutical Compounding
• Case-Based Learning: Management of Complex Regional Pain Syndrome with a Transdermal Unlicensed Medication The Pharmaceutical Journal
  Abstract
  Abstract: This case study considers the use of unlicensed topical medications for chronic pain when commercial medications are unsuccessful.
• Case Reports: Compounding to Relieve Arthritis Pain International Journal of Pharmaceutical Compounding
• Characterization of the Percutaneous Absorption of Ketoprofen Using the Franz Skin Finite Dose Model Postgraduate Medicine
  Abstract
  Objectives: Ketoprofen is an analgesic, anti-inflammatory agent commonly used in the management of chronic musculoskeletal pain. The aim of this study is to characterize the percutaneous absorption of 2 ketoprofen formulations (ketoprofen 10% in Pluronic Lecithin Organogel (PLO) and ketoprofen 10% in Lipoderm, referred to as phospholipid base), when applied to the human cadaver trunk skin, in vitro, using the Franz skin finite dose model. PLO and phospholipid base are vehicles used to facilitate the delivery of drugs into and through the skin following topical applications.
  
  Methods: The percutaneous absorption of ketoprofen was evaluated using human cadaver trunk skin from 3 donors. The skin was cut into small sections and cultured within Franz diffusion cells. A variable finite dose of each formulation was then applied to 3 replicate skin sections per donor and receptor solutions were collected at predetermined time points (0, 4, 8, 12, 24, 32, and 48 hr). After the last receptor sample was collected, skin surfaces were washed and split into epidermis and dermis. Collected samples were analyzed using HPLC.
  
  Results: Both PLO and phospholipid base were capable of facilitating the absorption of ketoprofen across human cadaver trunk skin. However, ketoprofen, when in phospholipid base, showed higher mean total absorption (p = 0.022) and faster rate of absorption (p < 0.05 at 2, 6, 10, and 18 hr) than when in PLO.
  
  Conclusion: Chronic musculoskeletal pain can be a major burden for most patients, affecting their lifestyle and reducing overall quality of life. When compared to PLO, phospholipid base has the ability to potentially deliver higher concentrations of ketoprofen to underlying soft tissues and at a more rapid rate. With more ketoprofen at the site of injury, the analgesic and anti-inflammatory effects will likely be enhanced, potentially reducing pain and improving quality of life.
• Clinical Nuggets and Pearls: Chronic Neuropathic Pain and Opioid Tolerance International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: The author focuses on chronic neuropathic pain and opioid tolerance. He provides a seven-step protocol for using N-methyl-D-aspartate antagonists to reduce opioid load and an algorithm for treating chronic neuropathic pain. Side effects caused by opioids and N-methyl-D-aspartate antagonists are compared and contrasted, and a figure illustrates a map of the human dermatomes.
• Compounded Analgesic Therapy for Disorders of Movement: Arthritis, Neuropathic Pain, and Postpolio Syndrome International Journal of Pharmaceutical Compounding
• Compounded Gabapentin for Neuropathic Pain: Stability and Beyond-Use Date (BUD) in Some Commonly Used Bases  Journal of the American Pharmacists Association
• Compounded Topical Gabapentin for Neuropathic Pain: Does Choice of Base Affect Efficacy? International Journal of Pharmaceutical Compounding
• Development and Evaluation of Topical Gabapentin Formulations  Pharmaceutics
• Ketamine Hydrochloride 5%, Gabapentin 10%, Clonidine Hydrochloride 0.2%, and Baclofen 2% in Lipoderm International Journal of Pharmaceutical Compounding
• Pain Management Therapy: The Benefits of Compounded Transdermal Pain Medication  Journal of General Practice
  Abstract
  Abstract: The high worldwide incidence of both acute and chronic pain leads to widespread consequences for both the healthcare system and the economy. First-line pain treatment options are typically oral pain medications; however, concerns regarding side effects, prescription drug abuse, risk of overdose, patient non-adherence to treatment regimens, and lack of efficacy in certain conditions provide a number of challenges for both healthcare providers and patients. As a result, healthcare providers have become increasingly interested in new ways to manage pain and develop customized treatment plans for their patients. Compounded transdermal pain medication may offer benefits such as customizable dosages and formulations, the ability to combine multiple drugs with various mechanisms of action, the likelihood of lower systemic absorption with minimization of side effects, more convenience and consequent improved adherence to treatment regimens, and minimization of risk of abuse and addiction. This review offers an overview of examples to provide evidence of the benefits of transdermal compounded pain medication in the treatment of a number of pain-related conditions, including neuropathic, musculoskeletal, arthritis-related, and postoperative pain, among other conditions.
• The Role of Transdermal Compounding in Opioid Safety Journal of Opioid Management
  Abstract
  Abstract: Since the number of prescriptions for opioid medications have continued to rise, there have been questions about the safety of using opioids in pain management. Traditionally, opioid analgesics were reserved for a few select conditions, such as terminal illness and surgery, but currently opioids have been readily prescribed for multiple conditions. The objective of this manuscript is to clarify the current state of opioid use and to discuss alternative transdermal analgesic therapies in pain management. Transdermal compounded medications are patient-specific and customizable to include different types of drugs, in various dosage strengths, that are to be delivered simultaneously in one application. Due to the different origins and types of pain, treatments may be most beneficial with multiple classes of drugs with various mechanisms of action. In addition, combination drug therapy may include nontraditional pain management options, and has the ability to maximize therapeutic effects of medications through additive or synergistic properties, without increasing the dosage strengths of the drugs. Many of the challenges faced when using oral opioid therapy may be overcome by using transdermal drug delivery since this route of administration reduces adverse effects, increases patient compliance, and limits exposure to potentially abusive drugs. Although prescribing practices surrounding opioids remains to be a controversial topic, the use of compounded pain medications may help healthcare providers effectively treat their patients while avoiding the use of addictive drugs.
• Topical Ketamine with Other Adjuvants: Underutilized for Refractory Cancer Pain: a Case Series and Suggested Revision of the World Health Organization Stepladder for Cancer Pain  Journal of Palliative Medicine
• Topical Methadone: An Alternative for Pain Control in End-of-Life Management  Journal of Palliative Medicine
• Topical Prazosin Attenuates Sensitivity to Tactile Stimuli in Patients with Complex Regional Pain Syndrome European Journal of Pain
• Transdermal Gel in the Treatment of Postoperative Pain International Journal of Pharmaceutical Compounding
• Unique Challenges in Compounding: Managing Severe Musculoskeletal Pain in a Recovered Substance Abuser International Journal of Pharmaceutical Compounding
• Analysis of Diltiazem in Lipoderm Transdermal Gel Using Reversed-Phase High-Performance Liquid Chromatography Applied to Homogenization and Stability Studies Journal of Pharmaceutical and Biomedical Analysis
• Impact of the Chemical and Physical Stability of Ketoprofen Compounded into Various Pharmaceutical Bases on its Topical and Transdermal Delivery Pharmaceutical Development and Technology
• A Pilot Study of Transdermal Gabapentin in Cats Journal of Veterinary Internal Medicine
• Diltiazem 5% in Lipoderm, Veterinary International Journal of Pharmaceutical Compounding
• Drug Exposure and Clinical Effect of Transdermal Mirtazapine in Healthy Young Cats: a Pilot Study  Journal of Feline Medicine and Surgery
• In Vitro Characterization of the Percutaneous Absorption of Tramadol Into Inner Ear Domestic Feline Skin Using the Franz Skin Finite Dose Model Veterinary Medicine and Animal Sciences
  Abstract
  Abstract: Pain, whether it is acute or chronic, can induce stress and reduce overall quality of life for domestic felines. Tramadol, a synthetic opioid that exerts analgesic effects by binding to μ-opioid receptors as well as inhibiting neuronal reuptake of norepinephrine and serotonin, can be used alone or in combination with NSAIDs for the treatment of domestic feline pain. Tramadol can be incorporated into transdermal bases such as PLO or Lipoderm for transdermal delivery. The purpose of this study is to characterize the percutaneous absorption of two tramadol formulations (Tramadol 100 mg/g in PLO and Tramadol 100 mg/g in Lipoderm), when applied to the inner ear of domestic feline skin, In vitro, using the Franz skin finite dose model. A variable finite dose (e.g., 25 μg/cm2) of each formulation was applied to skin sections from two donors and cultured within Franz diffusion cells for 48 hr. Tramadol total absorption, rate of absorption, surface wash, and skin content were quantified using HPLC analysis. Results show that both PLO and Lipoderm were capable of facilitating the percutaneous absorption of tramadol across ex-vivo domestic feline inner ear skin. However, tramadol content within surface wash (3.65%±0.14) was lower for the Lipoderm formulation, which potentially correlates to the higher total absorption (100.40%±3.24) of tramadol when in Lipoderm. Although the rise to peak rate of absorption was approximately 2.5 hr for both formulations, the decline in rate was steadier and more predictable for tramadol in Lipoderm than in PLO. Results of this study can help practitioners and pharmacists predict the in vivo percutaneous absorption of tramadol in domestic felines. The prediction can then guide them in selecting the most favorable transdermal base when prescribing and compounding with tramadol for domestic feline use.
• Methimazole for Feline Hyperthyroidism Australian Pharmacist
• Serum Levetiracetam Concentrations After Transdermal Levetiracetam Administration, 3 Times Daily, to Healthy Cats  Journal of Veterinary Internal Medicine
• Transdermal Amlodipine Besylate in Lipoderm for the Treatment of Feline Hypertension: A Report of Two Cases International Journal of Pharmaceutical Compounding
• Treatment of Feline Hypertension With Transdermal Amlodipine: A Pilot Study Journal of the American Animal Hospital Association
• Unlicensed Transdermal Medications in Feline Patients: Three Case Reports International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: In veterinary clinical practice, conventional pharmacological treatments such as commercial capsules, tablets, or oral liquids may be difficult to administer to feline patients. Noncompliance, which is estimated to account for the majority of treatment failures, may potentially be overcome with alternative, customized treat- ment options such as topically applied, permeation-enhancing (transdermal) unlicensed medications. These medications allow for the percutaneous absorption of drugs into and through the animal’s skin, bypassing the first-pass metabolism, potentially allowing for greater bioavailability, and thus decreasing dosage to achieve therapeutic effects. In these case reports, the efficacy of two unlicensed transdermal medications is demonstrated by the successful treatment of three feline patients, refractory to conventional pharmacotherapy. In case 1, the veterinary physician prescribed gabapentin 10 mg/0.1 mL topical Lipoderm, a permeation-enhancing base, to be applied three times a day inside the cat’s ear, in order to manage the unconscious fits following a road traffic accident. In cases 2 and 3, two cats were prescribed fluoxetine 40-mg/g topical Lipoderm, to be applied once a day, in order to manage the inappropriate behavior (urination and defecation). Following three months of transdermal treatment, the quality of life of the three cats and their owners increased considerably, as demonstrated by the results of the validated, Health Related Quality of Life questionnaires employed before treatment (retrospectively) and after treatment. Permeation-enhancing (transdermal) medications are a promising dosage form in veterinary pharmacotherapy. The benefits and versatility of these alternative, customized treatment options are worth considering in current therapeutics.
• Topical Gabapentin in the Treatment of Localized and Generalized Vulvodynia  Obstetrics and Gynecology
• 2,6-Dithiopurine, a Nucleophilic Scavenger, Protects Against Mutagenesis in Mouse Skin Treated in Vivo with 2-(Chloroethyl) Ethyl Sulfide, a Mustard Gas Analog Toxicology and Applied Pharmacology
• Baclofen 2%, Clonidine HCl 0.2%, Gabapentin 10%, and Ketamine HCl 5% in Lipoderm US Pharmacist: A Jobson Publication
• Diltiazem 5% in Lipoderm, Veterinary International Journal of Pharmaceutical Compounding
• Efficacy of an Experimental Azithromycin Cream for Prophylaxis of Tick-Transmitted Lyme Disease Spirochete Infection in a Murine Model  Antimicrobial Agents and Chemotherapy
• Fluoxetine Hydrochloride 5 mg/g in Lipoderm Transdermal Base US Pharmacist: A Jobson Publication
• Ketamine Hydrochloride 10%, Gabapentin 10%, and Ketoprofen 10% in Lipoderm US Pharmacist: A Jobson Publication
• Sertraline 4 mg/0.1 mL in Lipoderm US Pharmacist: A Jobson Publication
• Topical Ketamine-Amitriptyline-Lidocaine for Chronic Pruritus: A Retrospective Study Assessing Efficacy and Tolerability  Journal of the American Academy of Dermatology
• Topical Nanofat Biocrème Improves Aesthetic Outcomes of Nonablative Fractionated Laser Treatment: A Preliminary Report  Anesthetic Surgery Journal
• Transdermal Delivery of (‐)‐Epigallocatechin‐3‐Gallate, a Green Tea Polyphenol, in Mice Journal of Pharmacy and Pharmacology
• Transdermal Therapeutics Journal of the American Animal Hospital Association

• A Compounded Topical Pain Cream for Wrist Osteoarthritis
• Achilles Tendonitis: Pain Management by Compounding
• Case-based learning: management of complex regional pain syndrome with a transdermal unlicensed medication The Pharmaceutical Journal
• Pain Management: Plantar Fasciitis
• Pediatrics, Dermatological Conditions: Skin Viral Infection
• Topical Pain Relief for Degenerative Disc Disease
• Veterinary: Feline Patient Treated with Transdermal Gabapentin
• Veterinary: Behaviour Disorders in Cats
• Viral-Associated Trichodysplasia of Immunosuppression in a Renal Transplant Patient Journal of Drugs in Dermatology
• Unlicensed Transdermal Medications in Feline Patients: Three Case Reports International Journal of Pharmaceutical Compounding

• Evaluation of the In Vitro Human Trunk Skin Percutaneous Absorption of Ketamine HCl, Gabapentin, Clonidine HCl and Baclofen Using the Franz Skin Finite Dose Model PAINWeek 2013
• Characterization of the Human Skin Percutaneous Absorption of Lorazepam using the Franz Finite Dose In Vitro Permeation Test Model PAINWeek 2014
• Evaluation of the Skin Percutaneous Absorption of Four Drugs American Academy of Pain Management 25th Annual Clinical Meeting
• Compounding Opportunities for Oncology Patients 5th International Science of Nutrition in Medicine Conference (ACNEM)
• Evaluation of the In Vitro Percutaneous Absorption of Ketoprofen Transdermal Formulations PAINWeek 9th Annual Meeting
• In Vitro Characterization of the Percutaneous Absorption of Tramadol into Inner Ear Domestic Feline Skin Using the Franz Skin Finite Dose Model 2015 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition
• Case Report of a Skin Viral Infection Treated with a Topical Extemporaneous Preparation 9th European Paediatric Formulation Initiative (EuPFI) Conference
• The Use of Lipoderm as a Transdermal Base in Veterinary Compounding: A Systematic Literature Review British Small Animal Veterinary Association (BSAVA) Congress 2018

• Evaluation of the In Vitro Human Skin Percutaneous Absorption of Ketoprofen Using the Franz Finite Dose IVPT Model

• Ondansetron Compounded Topical Gel | Official as of 01-Jun-2018

• Evaluation of Compounded Transdermal Analgesic Formulations Using the Franz Finite Dose Model International Journal of Pharmaceutical Compounding

• Evaluation of a Compounding Phospholipid Base for the Percutaneous Absorption Of High Molecular Weight Drugs Using the Franz Finite Dose Model Skin Research & Technology
  Abstract
  Background: Permeation-enhancing compounding bases are aimed to facilitate the penetration of the active pharmaceutical ingredients (APIs) across the skin barrier.
  Objectives: The purpose of this study was to evaluate the percutaneous absorption of radiolabeled human insulin (¹⁴C-isototpe) when incorporated in a proprietary phospholipid base designed to deliver APIs with high molecular weights (HMW). The aim was not to claim the transdermal delivery of insulin with potential therapeutic applications in diabetes but, instead, to evaluate the ability of the compounding phospholipid base to deliver HMW drugs.
  Methods: The percutaneous absorption of ¹⁴C-insulin was determined using human torso skin and the Franz skin finite dose model. Two topical test formulations were prepared for in vitro evaluation: insulin 1% in phospholipid base (standard) and insulin 1% in phospholipid base HMW. The rate of percutaneous absorption (mean flux) and the distribution of ¹⁴C-insulin through the skin were evaluated for both topical test formulations. A two-way ANOVA was used to determine statistical differences.
  Results: The ¹⁴C-insulin was distributed into the stratum corneum, epidermis and dermis. Mean flux values showed a rapid penetration upon application and the maximum flux was achieved at 30 min, followed by a slow decline. Subsequently, a slower decline was observed for the topical test formulation including the phospholipid base HMW.
  Conclusion: The phospholipid base HMW facilitates the percutaneous absorption of HMW drugs across human cadaver skin and, therefore, it may potentially be a useful option for compounding pharmacists and practitioners when considering the skin for the percutaneous delivery of large drugs.

• Symptom Relief and Improved Quality of Life in Allergic Rhinitis Patients After Transdermal Allergy Immunotherapy Annals of Allergy, Asthma & Immunology

• Characterization of the Properties of Powder Excipients Commonly Used in Pharmaceutical Compounding, Particulate Science and Technology  Particulate Science and Technology
  Abstract
  Abstract: Capsules are the most popular and versatile dosage form produced in pharmaceutical compounding. In the preparations of capsules, powder excipients are nonactive ingredients that can be used for the purpose of increasing bulk, enhancing flow, and improving stability of a powder formulation. Flow properties of powder excipients can impact not only the compounding procedure, but also the uniformity and quality of the final product. In this study, an FT4 Powder Rheometer was used to compare dynamic, bulk, and shear properties of the following four powder excipients: Loxoral, Loxasperse, a commercial powder excipient, and lactose monohydrate. Changes in flow energy, measured as the powders are exposed to external conditions such as air, compression, consolidation, and shear forces, were used to compare flow properties of the four excipients. Results show Loxasperse to have superior dynamic properties, indicating more efficient packing potentials. Though Loxoral did not have the most favorable flow in terms of dynamic properties, Loxoral outranked the other excipients when comparing bulk and shear properties. Taking into account processing equipment and the external environment, compounding pharmacists can reevaluate current formulas to include excipients with more favorable flow properties, resulting in more uniform and higher quality products.
• Compounding Pearls - Wound Care: Base Selection International Journal of Pharmaceutical Compounding

• Antimicrobial Effectiveness Testing of Antihistamine and Corticosteroid in LoxaSperse™ Dispersion
• Antimicrobial Effectiveness Testing of a Budesonide LoxaSperse™ Dispersion
• Antimicrobial Effectiveness Testing of a Gentamicin LoxaSperse™ Dispersion
• Characterization of the Physical and Microbiological Properties of LoxaSperse™
• Evaluating the Effects of LoxaSperse™ Using an In Vitro Model of Human Respiratory Tract Tissue
• Microbiological Quality of LoxaSperse™ Dispersion Evaluated by Mikrocount® Combi
• The Antimicrobial Activity of Itraconazole and LoxaSperse™ Against Biofilms of C. albicans

• Respiratory System: Chronic Rhinosinusitis

• Characterization of the Physical and Microbiological Properties of a Powder Excipient Base (Loxasperse) 9th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology (PBP)

• Case Study: Personalized Oral Low-Dose Naltrexone Titration for Pain Management International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Naltrexone is a competitive opioid receptor antagonist indicated to treat opioid and alcohol dependence. In the U.S., naltrexone is commercially available as 50-mg tablets, and the adult dosage strength typically ranges between 50 mg once daily and 100 mg once daily. However, there is evidence to suggest that naltrexone prescribed in low doses, about 1/10th of the daily standard dosage, may be effective in managing a myriad of chronic conditions, including pain refractory to conventional pharmacological treatments. The U.S. Food and Drug Administration recently granted an orphan drug designation for low-dose naltrexone for the treatment of complex regional pain syndrome. This article provides a case study of a patient who was treated with a low dose of naltrexone for pain associated with the diagnosis of idiopathic hypereosinophilic syndrome.
• Characterization of the Properties of Powder Excipients Commonly Used in Pharmaceutical Compounding, Particulate Science and Technology  Particulate Science and Technology
  Abstract
  Abstract: Capsules are the most popular and versatile dosage form produced in pharmaceutical compounding. In the preparations of capsules, powder excipients are nonactive ingredients that can be used for the purpose of increasing bulk, enhancing flow, and improving stability of a powder formulation. Flow properties of powder excipients can impact not only the compounding procedure, but also the uniformity and quality of the final product. In this study, an FT4 Powder Rheometer was used to compare dynamic, bulk, and shear properties of the following four powder excipients: Loxoral, Loxasperse, a commercial powder excipient, and lactose monohydrate. Changes in flow energy, measured as the powders are exposed to external conditions such as air, compression, consolidation, and shear forces, were used to compare flow properties of the four excipients. Results show Loxasperse to have superior dynamic properties, indicating more efficient packing potentials. Though Loxoral did not have the most favorable flow in terms of dynamic properties, Loxoral outranked the other excipients when comparing bulk and shear properties. Taking into account processing equipment and the external environment, compounding pharmacists can reevaluate current formulas to include excipients with more favorable flow properties, resulting in more uniform and higher quality products.
• Combination Therapy of Oral LDN and Topical Pentoxifylline, Rifampin, Clindamycin for Hidradenitis Suppurativa International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease that may have profound effects on the patient’s quality of life. A personalized HS combination therapy treatment was prescribed to a 54-year-old female suffering from multiple painful sores, as follows: naltrexone capsules titrated from 0.5 mg up to 4.5 mg; pentoxifylline 5%, rifampin 2%, clindamycin 1%, and glycolic acid topical cream. Clinical improvements were observed using two disease-specific outcome measures: Hurley Staging System and HS Score. The patient’s HS improved from Stage II (moderate) to Stage I (mild), and the HS score decreased from 103 points with five anatomical regions reported, to 19 points with only three regions affected. Furthermore, the before and after treatment photographs showed a visible reduction in the number of boils/skin abscesses and an overall recovery. Improvements were also observed across all domains of the patient’s self-reported quality of life (Hidradenitis Suppurativa Quality of Life Assessment). The patient did not experience any undesirable effects. Compounded medications may be customized to meet the patient’s special needs and may be adjusted throughout the course of treatment to match the patient’s individual progress. Although further studies are necessary, this personalized, combination therapy may be a key treatment option in HS.
• Investigation of the Bioaccessibility of Progesterone (Micronized and Nonmicronized), Using an In Vitro Model of the Human Gastrointestinal System  International Journal of Applied Science and Technology
  Abstract
  Abstract: The aim of this study is to evaluate the bioaccessibility of two progesterone oral formulations (micronized progesterone 100 mg SR capsules and milled progesterone 100 mg SR capsules), using an in vitro model of the human GI tract. Results show that overall bioaccessibility of micronized progesterone (21.8%) was significantly greater than that of milled progesterone (1.9%), p < 0.001. The higher total bioaccessibility could potentially be due to the smaller particle size of micronized progesterone (< 6 μm), in comparison to that of milled progesterone (approximately 92 μm). One may hypothesize that oral compounded micronized progesterone has the potential for greater bioavailability because of the significantly higher bioaccessibility of micronized progesterone in comparison to milled progesterone. Knowledge of this study’s results may be useful for practitioners when justifying the viability of using micronized progesterone over milled progesterone in the management of postmenopausal symptoms.

• Case Study: Personalized Oral Low-Dose Naltrexone Titration for Pain Management International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Naltrexone is a competitive opioid receptor antagonist indicated to treat opioid and alcohol dependence. In the U.S., naltrexone is commercially available as 50-mg tablets, and the adult dosage strength typically ranges between 50 mg once daily and 100 mg once daily. However, there is evidence to suggest that naltrexone prescribed in low doses, about 1/10th of the daily standard dosage, may be effective in managing a myriad of chronic conditions, including pain refractory to conventional pharmacological treatments. The U.S. Food and Drug Administration recently granted an orphan drug designation for low-dose naltrexone for the treatment of complex regional pain syndrome. This article provides a case study of a patient who was treated with a low dose of naltrexone for pain associated with the diagnosis of idiopathic hypereosinophilic syndrome.

• Comparison of Dissolution Properties of Piroxicam Using Microcrystalline Cellulose and a New Excipient (LoxOral™)
• Effect of LoxOral™ and Lactose on In Vitro Dissolution Studies of Progesterone Sustained Release Capsules
• Effect of Particle Size on the Bioaccessibility of Progesterone from LoxOral™ in an In Vitro Dynamic Gastrointestinal System
• Improvement of Dissolution Properties of Ketoconazole Using a New Excipient (LoxOral™) in Comparison with Microcrystalline Cellulose

• Characterization of the Properties of Powder Excipients Commonly used in Pharmaceutical Compounding 2014 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition
• A Comparison of the Bioaccessibility of Micronized and Milled Progesterone in an In Vitro Model of the Gastrointestinal System 2014 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition
• Dissolution of Piroxicam in Capsule Formulations studied with USP and Real-Time UV Imaging Methods 9th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology (PBP)

• Budesonide 1-mg/10-mL and 2-mg/10-mL Mucolox Oral Suspensions International Journal of Pharmaceutical Compounding
• Case Report of a Human Pappilomavirus Infection Treated with Green Tea Extract and Curcumin Vaginal Compounded Medications  International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: The human papillomaviruses are the most common sexually transmitted infections in the U.S., and the majority of these infections are cleared by the body's natural immune system without causing any harm. The high-risk human papillomavirus types, however, cause approximately 5 percent of all cancers worldwide. A prophylactic vaccine was recently introduced, but there is still no commercially available treatment that targets active infections. This case study discusses a 48-year-old female who was diagnosed as human papillomavirus positive (+) following a routine gynecological examination. Upon discussion with a compounding pharmacist, the obstetrician/gynecologist prescribed Green Tea Extract 15% Vaginal Cream and Curcumin 250 mg Vaginal Suppositories, to be applied on alternate days for a period of 3 months. After only 1 month of treatment, the gynecologic cytology report tested negative for human papillomavirus. The patient was very satisfied with the compounded medications prescribed (treatment satisfaction questionnaire) and the human papillomavirus (+) diagnosis was reported to have only little/moderate impact on the patient’s sexual life (Human Papillomavirus Impact Profile questionnaire). The successful results obtained in this case study confirm the beneficial properties of green tea extract and curcumin against the viruses, and highlight the key role of pharmaceutical compounding in current therapeutics.
• Compounding Pearls - Wound Care: Base Selection International Journal of Pharmaceutical Compounding
• Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases: A Phase II Randomized Clinical Trial Journal of Oral Pathology & Medicine
  Abstract
  Background: Mucolox™ is a mucosal drug delivery system that prolongs the contact time between the oral mucosa and topical corticosteroids, potentially reducing the need for multiple applications daily. This study aimed to assess the clinical efficacy and tolerability of dexamethasone 0.5 mg/5 mL solution in Mucolox™ for the management of oral inflammatory ulcerative diseases.
  
  Methods: Participants were randomly assigned to receive dexamethasone 0.5 mg/5 mL in Mucolox™ (Mucolox™ arm) or dexamethasone 0.5 mg/5 mL solution (standard arm) and instructed to swish/gargle for 5 min three times daily. Changes from pre- to posttreatment patient's sensitivity score (0–10 on a visual analog scale), reticulation/erythema/ulceration score, and oral health-related quality of life were evaluated at baseline and at the end of the study period.
  
  Results: Twenty nine patients (75% females) with a median age of 58 years (range 18–79) were enrolled and randomly allocated to the Mucolox™ or standard arm. One subject was excluded. Although statistically significant in both arms, the pre- to posttreatment sensitivity score reduction was higher in the Mucolox™ arm (6.3 vs. 4.4-point reduction). Both arms showed a decrease in the reticulation/erythema/ulceration score between the two visits (7.2 vs. 4.7 [Mucolox™ arm]; 8.0 vs. 4.8 [standard arm]; p > 0.05). Mucolox™ in dexamethasone 0.5 mg/5 mL solution was better tolerated when taste and level of comfort were considered.
  
  Conclusion: Both treatments were effective in the management of oral inflammatory ulcerative diseases. Dexamethasone 0.5 mg/5 mL in Mucolox™ was better tolerated and was slightly better in controlling patients' oral sensitivity. Larger studies are needed to confirm these findings in oral inflammatory ulcerative diseases patients.
   
• Dexamethasone Solution and Dexamethasone In Mucolox for the Treatment of Oral Lichen Planus: a Preliminary Study Oral Surgery Oral Medicine Oral Pathology Oral Radiology
  Abstract
  Objective: The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP).
  
  Study Design: Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test.
  
  Results: Twenty-four patients (females n = 21; median age 64.5 years; range 45–80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58).
  
  Conclusion: Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.
   
• Effects of Compounded Stanford Modified Oral Rinse (MucoLox) on the Survival and Migration of Oral Keratinocytes and Fibroblasts: Implications for Wound Healing International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Several oral rinses are commercially available to alleviate the symptoms of oral mucositis. Prolonged retention of active pharmaceutical ingredients in the oral cavity is a major problem. In this study, we modified the Stanford oral rinse by including a proprietary mucoadhesive polymer called MucoLox, which we hypothesized would improve active pharmaceutical ingredient mucoadhesion. Characterization of this newly compounded oral rinse showed absence of cytotoxicity in human oral keratinocyte and fibroblast cell lines. The compounded formulation significantly stimulated the migration of these two cell lines in Oris Cell Migration Assay plates, better than the reference commercial product Magic mouthwash. Based on this in vitro study, the new Stanford modified oral rinse with MucoLox is safe and may promote healing of oral mucositis.
• Evaluation of the Safety, Cell Migration and Mucoadhesive Properties of a Mucoadhesive Polymer Blend in Human Oral Mucosa AAPS PharmSciTech
  Abstract
  Abstract: The efficacy of active pharmaceutical ingredients (API) in compounded medications for oral mucosa greatly depends on the composition of the base. Here, we assessed the safety, facilitation of cell migration, and mucoadhesive properties of a newly developed mucoadhesive polymer blend (MPB) which contains pullulan, tamarindus indica polysaccharide, and sodium hyaluronate. No cell death was observed when human oral keratinocyte (HOK) and fibroblast (HOrF) cells were exposed to 1% MPB for 24 h. Epithelial cells in a 3D buccal tissue model (EpiOral) were unaffected when exposed to 50% MPB for 20 h whereas 1% Triton X-100 killed 93% cells after 4.5 h. The expressions of cytokines IL1α and IL1β and cell proliferation markers PCNA, CYCLIN A, and CYCLIN D1 in EpiOral tissue did not increase suggesting that MPB is neither an irritant nor a mitogen. Markers of apoptosis such as cleavage of CASPASES 8/9, upregulation of pro-apoptosis NOXA protein, and downregulation of anti-apoptosis XIAP protein were observed in Triton X-100-treated cells but not in cells exposed to MPB. The migration of HOK and HOrF cells was stimulated by MPB, and the expression of E-CADHERIN in the EpiOral tissues was unaffected. Moreover, MPB showed stronger mucoadhesion on the human EpiOral tissue model compared with a reference product. We conclude that MPB can safely deliver API within the oral mucosa, facilitate cell migration, and may increase drug efficacy through its strong mucoadhesive property.
• Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox) International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Budesonide is a corticosteroid that has been shown effective in the treatment of eosinophilic esophagitis, but there are currently no commercial medicines to treat this chronic allergic/immune condition, despite its prevalence in the U.S. Therefore, pharmaceutical compounding is the alternative choice to meet the therapeutic need of eosinophilic esophagitis patients. Two budesonide mucoadhesive oral suspensions (1 mg/10 mL and 2 mg/10 mL) were developed using the compounding vehicle MucoLox, a proprietary mucoadhesive polymer blend that promotes mucosal adhesion. The physical and chemical stability of the oral suspensions was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH and density, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both oral suspensions were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the budesonide 1-mg/10-mL and 2-mg/10-mL mucoadhesive oral suspensions (MucoLox), in amber plastic bottles, is six months at both room temperature and refrigerated conditions.

• Assessment of the Mucoadhesive Properties of MucoLox™ Using a 3D Model of the Human Oral Mucosa
• Evaluation of the Safety and Toxicological Profile of MucoLox™: Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa (Part 1/3)
• Evaluation of the Safety and Toxicological Profile of MucoLox™: Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa (Part 2/3)
• Evaluation of the Safety and Toxicological Profile of MucoLox™: Human Oral Mucosa, Nasal Mucosa and Vaginal Mucosa (Part 3/3)

• Case Report of a Human Pappilomavirus Infection Treated with Green Tea Extract and Curcumin Vaginal Compounded Medications  International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: The human papillomaviruses are the most common sexually transmitted infections in the U.S., and the majority of these infections are cleared by the body's natural immune system without causing any harm. The high-risk human papillomavirus types, however, cause approximately 5 percent of all cancers worldwide. A prophylactic vaccine was recently introduced, but there is still no commercially available treatment that targets active infections. This case study discusses a 48-year-old female who was diagnosed as human papillomavirus positive (+) following a routine gynecological examination. Upon discussion with a compounding pharmacist, the obstetrician/gynecologist prescribed Green Tea Extract 15% Vaginal Cream and Curcumin 250 mg Vaginal Suppositories, to be applied on alternate days for a period of 3 months. After only 1 month of treatment, the gynecologic cytology report tested negative for human papillomavirus. The patient was very satisfied with the compounded medications prescribed (treatment satisfaction questionnaire) and the human papillomavirus (+) diagnosis was reported to have only little/moderate impact on the patient’s sexual life (Human Papillomavirus Impact Profile questionnaire). The successful results obtained in this case study confirm the beneficial properties of green tea extract and curcumin against the viruses, and highlight the key role of pharmaceutical compounding in current therapeutics.
• Palliative Care: Chemoradiation Therapy-Induced Oral Mucositis

• Evaluation of the Mucosal Retention Properties of Mucoadhesive Polymers Using a 3D Model of the Human Oral Mucosa 2015 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition

• Ketamine Compounded Oral Solution | Official as of 01-Dec-2021

• A Topical Naltrexone Formulation for Surgical Wound Healing: A Case Report Journal of Cosmetic Dermatology
  Abstract
  Background: In current guidelines, there is no specific therapeutic recommendation for promoting surgical wound healing. Proper postsurgical wound care regimen can speed up wound healing and prevent abnormal scarring.
  
  Aims: The purpose of this case study was to evaluate the effectiveness of a compounded topical formulation containing naltrexone in managing surgical wound in a patient after Mohs micrographic surgery (MMS).
  
  Patients/Methods: A patient started to apply the topical naltrexone formulation two days after the MMS on his hand. Images of the wound and a Patient Scar Assessment Questionnaire (PSAQ) were used to evaluate the clinical outcomes.
  
  Results: The wound completely healed, and the hand function was fully recovered following application of the formulation for 2 weeks. No abnormal scarring was formed, and the scar was only slightly noticeable after 2 months.
  
  Conclusion: This case study demonstrated the effectiveness of the topical naltrexone formulation in surgical wound management.
• Case Reports on the Use of Aloe Vera, Naltrexone, and Topiramate for the Treatment of Scars International Journal of Pharmaceutical Compounding
• Case Report: Diabetic Foot Ulcer Infection Treated With Topical Compounded Medications International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: An adult diabetic male with three toes amputated on his right foot presented with an ulcer infection on his left foot, unresponsive to conventional antifungal oral medication for over two months. The ulcerated foot wound had a large impairment on the patient’s quality of life, as determined by the Wound-QoL questionnaire. The compounding pharmarcist recommended and the physician prescribed two topical compounded medicines, which were applied twice a day, free of charge at the compounding pharmacy. The foot ulcer infection was completely resolved following 13 days of treatment, with no longer any impairment on the patient’s quality of life. This scientific case study highlights the value of pharmaceutical compounding in current therapeutics, the importance of the triad relationship, and the key role of the compounding pharmacist in diabetes care.
• Clotrimazole 2%, Ibuprofen 2%, Metronidazole 2%, Nifedipine 0.2%, and Dexpanthenol 3% in PracaSil-Plus US Pharmacist: A Jobson Publication
• Compounding Pearls - Wound Care: Base Selection International Journal of Pharmaceutical Compounding
• Pitch Ointment: Applications in Scar and Wound Management  International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: There is a high incidence of household knife-related injuries requiring emergency department treatment in the U.S. The Pitch Ointment, a named formula developed by a compounding pharmacist, was used separately by two patients who suffered a knife injury in a finger and a foot. This formula combines Pinene (L-Alpha) 0.5% and Canada Balsam 5% in PracaSil-Plus, special ingredients with applications in scar and wound healing. The patients’ level of satisfaction with the Pitch Ointment was very high since all 4 treatment satisfaction domains by the Treatment Satisfaction Questionnaire for Medication (effectiveness, side effects, convenience, global satisfaction) were rated over 85. These results are consistent with the clinical improvements observed in the before and after treatment photographs. The success of these case reports is evidence to suggest that the Pitch Ointment may be recommended by compounding pharmacists as a viable treatment option in scar and wound management.

• In Vitro Evaluation of the Safety Profile of PracaSil™-Plus on Human Melanoma Tissue

• A Topical Naltrexone Formulation for Surgical Wound Healing: A Case Report Journal of Cosmetic Dermatology
  Abstract
  Background: In current guidelines, there is no specific therapeutic recommendation for promoting surgical wound healing. Proper postsurgical wound care regimen can speed up wound healing and prevent abnormal scarring.
  
  Aims: The purpose of this case study was to evaluate the effectiveness of a compounded topical formulation containing naltrexone in managing surgical wound in a patient after Mohs micrographic surgery (MMS).
  
  Patients/Methods: A patient started to apply the topical naltrexone formulation two days after the MMS on his hand. Images of the wound and a Patient Scar Assessment Questionnaire (PSAQ) were used to evaluate the clinical outcomes.
  
  Results: The wound completely healed, and the hand function was fully recovered following application of the formulation for 2 weeks. No abnormal scarring was formed, and the scar was only slightly noticeable after 2 months.
  
  Conclusion: This case study demonstrated the effectiveness of the topical naltrexone formulation in surgical wound management.
• Case Report: Diabetic Foot Ulcer Infection Treated With Topical Compounded Medications International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: An adult diabetic male with three toes amputated on his right foot presented with an ulcer infection on his left foot, unresponsive to conventional antifungal oral medication for over two months. The ulcerated foot wound had a large impairment on the patient’s quality of life, as determined by the Wound-QoL questionnaire. The compounding pharmarcist recommended and the physician prescribed two topical compounded medicines, which were applied twice a day, free of charge at the compounding pharmacy. The foot ulcer infection was completely resolved following 13 days of treatment, with no longer any impairment on the patient’s quality of life. This scientific case study highlights the value of pharmaceutical compounding in current therapeutics, the importance of the triad relationship, and the key role of the compounding pharmacist in diabetes care.
• Case Reports on the Use of Aloe Vera, Naltrexone, and Topiramate for the Treatment of Scars International Journal of Pharmaceutical Compounding
• Pitch Ointment: Applications in Scar and Wound Management  International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: There is a high incidence of household knife-related injuries requiring emergency department treatment in the U.S. The Pitch Ointment, a named formula developed by a compounding pharmacist, was used separately by two patients who suffered a knife injury in a finger and a foot. This formula combines Pinene (L-Alpha) 0.5% and Canada Balsam 5% in PracaSil-Plus, special ingredients with applications in scar and wound healing. The patients’ level of satisfaction with the Pitch Ointment was very high since all 4 treatment satisfaction domains by the Treatment Satisfaction Questionnaire for Medication (effectiveness, side effects, convenience, global satisfaction) were rated over 85. These results are consistent with the clinical improvements observed in the before and after treatment photographs. The success of these case reports is evidence to suggest that the Pitch Ointment may be recommended by compounding pharmacists as a viable treatment option in scar and wound management.
• Second-degree Skin Burn Injury Following a Domestic Incident
• Surgical Scar Management with Topical Treatment

• Case Report: Treatment of Diabetic Ulceration with Compounded Medicines West Coast Pharmacy Exchange
• Case Study: Pediatrics Wound Healing with Topical Compounded Formulations 15th European Paediatric Formulation Initiative (EuPFI) Conference
• Compounding Opportunities for Oncology Patients 5th International Science of Nutrition in Medicine Conference (ACNEM)

• Amlodipine Besylate 0.5-mg/mL to 10-mg/mL in SuspendIt Oral Suspension International Journal of Pharmaceutical Compounding
• Clindamycin 10-mg/mL Oral Suspension International Journal of Pharmaceutical Compounding
• Clindamycin Hydrochloride 10-mg/mL Oral Suspension International Journal of Pharmaceutical Compounding
• Comparison of Rheological and Sedimentation Behavior of Commercially Available Suspending Vehicles for Oral Pharmaceutical Preparations International Journal of Pharmaceutical Compounding
• Microbiological Stability of Allopurinol, Clindamycin Hydrochloride, Naltrexone Hydrochloride, Spironolactone and Ursodiol Oral Liquids Compounded in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Naltrexone Hydrochloride 0.5 mg/mL and 5.0 mg/mL in SuspendIt Suspension International Journal of Pharmaceutical Compounding
• Physicochemical and Microbiological Stability of Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical and Microbiological Stability of Azathioprine Suspensions in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical and Microbiological Stability of Compounded Bethanechol Chloride Oral Suspensions in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Bethanechol chloride is a cholinergic agent used to treat acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. It is available in the United States as tablets for oral administration in four dosage strengths: 5 mg, 10 mg, 25 mg, and 50 mg. A review of the therapeutic uses of bethanechol chloride reveals the need for flexibility in dosing. This flexibility is readily achieved using an oral liquid dosage form. However, no commercial liquid dosage form of bethanechol chloride currently exists. An extemporaneously compounded suspension from pure drug powder or commercial tablets would provide a flexible, customizable option to meet unique patient needs with convenient and accurate dosing options. The purpose of this study was to determine the physicochemical and microbiological stability of extemporaneously compounded bethanechol chloride suspensions using two brands of commercially available tablets (Amneal and Upsher-Smith) in the PCCA Base, SuspendIt. This base is a sugar-free, paraben-free, dye-free, and gluten-free thixotropic vehicle containing a natural sweetener obtained from the monk fruit. The study design included two bethanechol chloride concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stability-indicating ultra-high-performance liquid chromatographic assay for the determination of the chemical stability of bethanechol chloride in PCCA SuspendIt was validated. Suspensions of bethanechol chloride were prepared from the tablets in PCCA SuspendIt at 1-mg/mL and 5-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in amber plastic prescription bottles at room temperature (25°C). Samples were assayed initially, and on the following time points (days): 14, 30, 60, 90, and 180. Physical data such as pH and appearance were also noted. Microbiological stability was tested. A stable extemporaneous product is defined as one that retains at least 90% of the initial drug concentration throughout the sampling period and is protected against microbial growth. Using this criterion, no significant degradation of the bethanechol chloride was observed over the 180-day test period for either concentration at room temperature. Drug concentrations were at, or above 93% of initial values for both brands of commercially available tablets. No microbial growth was observed. pH values remained fairly constant. This study demonstrates that bethanechol chloride tablets are physically, chemically, and microbiologically stable in PCCA SuspendIt for 180 days at room temperature at both concentrations studied, thus providing a viable, compounded alternative for bethanechol chloride in a liquid dosage form, with an extended BUD to meet patient needs.
• Physicochemical and Microbiological Stability of Compounded Clonidine Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical and Microbiological Stability of Compounded Metronidazole Suspensions in PCCA SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical and Microbiological Stability of Extemporaneously Compounded Hydrocortisone Oral Suspensions in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical and Microbiological Stability of Pyrimethamine in Paraben-free PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical Stability of an Oral Suspension of Trimethoprim 20 mg/mL in Combination with Sulfadiazine 200 mg/mL in PCCA Base SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical Stability of Compounded Allopurinol Suspensions in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base Suspendlt International Journal of Pharmaceutical Compounding
• Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt  International Journal of Pharmaceutical Compounding
• Physicochemical Stability of Extemporaneously Prepared Oral Suspension of Fluconazole 50 mg/mL in SuspendIt™  Pharmaceutical Technology in Hospital Pharmacy
  Abstract
  Background: There is a lack of an age-appropriate formulation of fluconazole. The extemporaneous preparation of an oral suspension with an extended beyond-use-date may represent a good therapeutic alternative for the paediatric population.
  
  Methods: A fluconazole 50 mg/mL oral suspension was prepared and evenly distributed into twenty amber plastic bottles: ten bottles were stored in controlled room temperature (25 °C) whereas the remainder ten bottles were stored in refrigerated temperature (5 °C). The physical characteristics (colour/appearance, odor, pH and density) and chemical characteristics [fluconazole concentration using Ultra High Performance Liquid Chromatography (UPLC)] of the oral suspension were tested at nine pre-determined time-points over a period of 182 days.
  
  Results: The density, pH and mean concentration of the oral suspension did not change significantly. The recovery of fluconazole ranged from 92.67 % to 98.79 % (5 °C) and from 94.31 % to 100.02 % (25 °C), both within the specification limits.
  
  Conclusion: A palatable, sugar-free formula was developed for fluconazole 50 mg/mL in the oral suspending vehicle SuspendIt™ to allow an easy and rapid extemporaneous preparation in the hospital setting. The beyond-use-date of the formula was determined using a valid, stability-indicating analytical method and it was concluded that the extemporaneously prepared oral suspension is stable for 6 months at refrigerated and controlled room temperature.
   
• Spironolactone 5 mg/mL in SuspendIt Oral Suspension (Mar/Apr 2018) International Journal of Pharmaceutical Compounding
• Spironolactone 5 mg/mL in SuspendIt Oral Suspension (Nov/Dec 2017) International Journal of Pharmaceutical Compounding
• Stability of Clindamycin Hydrochloride in PCCA Base SuspendIt International Journal of Pharmaceutical Compounding
• Stability of Compounded Ursodiol Suspensions in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Stability of Spironolactone Oral Suspension in PCCA Base, SuspendIt International Journal of Pharmaceutical Compounding
• Trimethoprim 20 mg/mL and Sulfadiazine 100 mg/mL in Suspendit Oral Suspension International Journal of Pharmaceutical Compounding

• Evaluation of the Content Uniformity of 8 SuspendIt™ Formulations

• Physical and Chemical Stability of Phenobarbital 1 mg/mL and 50 mg/mL Oral Suspensions (SuspendIt™) 9th European Paediatric Formulation Initiative (EuPFI) Conference
• Physicochemical Stability of Allopurinol, Amitriptyline Hydrochloride, Amlodipine Besylate, Clindamycin Hydrochloride, Hydrocortisone, Metronidazole, Naltrexone Hydrochloride, Spironolactone, Trimethoprim with Sulfadiazine, and Ursodiol Extemporaneously Compounded Oral Suspensions in PCCA Base, SuspendIt 80th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2022
• Physicochemical and Microbiological Stability of Compounded Amitriptyline Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt American Pharmacists Association (APhA) 2022 Annual Meeting & Exposition
• Physicochemical and Microbiological Stability of Compounded Bethanechol Chloride Oral Suspensions in PCCA Base, SuspendIt 82nd FIP World Congress of Pharmacy and Pharmaceutical Sciences 2024
• Physicochemical and Microbiological Stability of Compounded Clonidine Hydrochloride Oral Liquid Dosage Forms in PCCA Base, SuspendIt 81st FIP World Congress of Pharmacy and Pharmaceutical Sciences 2023
• Physicochemical and Microbiological Stability of Melatonin 5 mg/mL Oral Compounded Suspension 81st FIP World Congress of Pharmacy and Pharmaceutical Sciences 2023
• Physicochemical and Microbiological Stability of Pyrimethamine in the Paraben-Free PCCA Base, SuspendIt American Pharmacists Association (APhA) 2023 Annual Meeting & Exposition 
• Physicochemical and Microbiological Stability of Tacrolimus Oral Extemporaneous Suspensions 15th European Paediatric Formulation Initiative (EuPFI) Conference
• Physicochemical and Microbiological Stability of Ursodiol Oral Compounded Suspensions 2022 American Society of Health-System Pharmacists (ASHP) Summer Meeting
• Physicochemical Stability of Chloral Hydrate 25 mg/mL and 100 mg/mL Oral Suspensions in SuspendIt® 13th European Paediatric Formulation Initiative (EuPFI) Conference
• Physicochemical Stability of Lansoprazole 3 mg/mL and 10 mg/mL Oral Suspensions in SuspendIt® 10th European Paediatric Formulation Initiative (EuPFI) Conference
• Physicochemical Stability of Omeprazole 2 mg/mL and 10 mg/mL Oral Suspensions in SuspendIt® 10th European Paediatric Formulation Initiative (EuPFI) Conference
• Physicochemical Stability of Pantoprazole 2 mg/mL Oral Suspension in SuspendIt® 14th European Paediatric Formulation Initiative (EuPFI) Conference
• Stability Study of Pediatric Oral Suspensions Indicated in the Treatment of Cardiovascular Disease 16th European Paediatric Formulation Initiative (EuPFI) Conference
• Validated Stability Studies for 40 Paediatric Extemporaneously Compounded Oral Solutions and Suspensions (SuspendIt) 80th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2022

• Clindamycin Hydrochloride Compounded Oral Solution | Official as of 01-Aug-2019
• Hydroxychloroquine Sulfate Compounded Oral Suspension | Official as of 01-Aug-2023
• Spironolactone Compounded Oral Suspension | Official as of 01-May-2021
• Ursodiol Compounded Oral Suspension | Official as of 01-Dec-2021

• Physicochemical Stability of Allopurinol, Amitriptyline Hydrochloride, Amlodipine Besylate, Clindamycin Hydrochloride, Hydrocortisone, Metronidazole, Naltrexone Hydrochloride, Spironolactone, Trimethoprim with Sulfadiazine, and Ursodiol Extemporaneously Compounded Oral Suspensions in Suspendit Base Pharmacy Education
• Validated Stability Studies for 40 Paediatric Extemporaneously Compounded Oral Solutions and Suspensions (SuspendIt) Pharmacy Education

• Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids Pharmaceutics
  Abstract
  Abstract: The paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt® Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.
• New SuspendIt Anhydrous Base US Pharmacist: A Jobson Publication

• Science Manual 2022

• Case Study: Absorption of Testosterone Cream Via Scrotal Delivery International Journal of Pharmaceutical Compounding
• Evaluation of the in-vitro Human Skin Percutaneous Absorption of Progesterone in Versabase Using-the Franz Skin Finite Dose Model Journal of Women’s Health Care 
  Abstract
  Abstract: Women may benefit from hormone replacement therapy to alleviate undesirable menopausal symptoms such as hot flashes, disruption of sleep and fatigue. Transdermal hormone replacement therapy consists in the delivery of hormones through the skin and into the blood stream, avoiding gastrointestinal drug absorption difficulties and the first pass effect. Transdermal compounded medications may be customized to meet the individual needs of women by changing the hormones used, the respective concentrations and the medicine’s formulation. Two compounded medications were prepared for progesterone 50 mg/g, as follows: Progesterone in VersaBase® Cream and progesterone in VersaBase® Cream Gel. The purpose of this study is to determine the in vitro human skin percutaneous absorption of progesterone for both test formulations. The Franz Skin Finite Dose Model was the methodology used to evaluate the total absorption, the rate of absorption and the skin content of progesterone applied to the outer surface of ex vivo skin. This model has proven to be a valuable tool for the study of percutaneous absorption of topically applied drugs and to accurately predict in vivo permeation kinetics. The skin samples were obtained within 24 h to 48 h of death from three adult Caucasian donors and a total of 17 Franz diffusion chambers were prepared for testing. Results are presented as the mean ± standard error per parameter, for each test formulation. The rate of percutaneous absorption, presented as mean flux, was similar for the two test formulations and characterized by 2 peaks at approximately 6 hours and 28 hours after dose application, followed by a decline in flux over time. The total absorption and the skin content of progesterone were also similar: 21.6% and 21.8% of the applied doses for the test formulations 1 and 2, respectively. Although in vitro, these results suggest that progesterone in VersaBase® is likely to be delivered through the skin and into the general circulation for systemic effects. Practitioners may then consider transdermal progesterone as a viable route of drug administration for menopausal women.
• Intravaginal Testosterone Improves Sexual Satisfaction and Vaginal Symptoms Associated With Aromatase Inhibitors The Journal of Clinical Endocrinology and Metabolism
• Physical and Chemical Stability of Estriol 0.025% to 1% Vaginal Creams (VersaBase) International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Estrogen replacement therapy is often recommended when female patients present with lower than normal physiologic levels, such as patients going through menopause. The physical and chemical stability of estriol 0.25 mg/g and 10 mg/g vaginal creams (VersaBase) was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both vaginal creams were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the estriol 0.025% to 1% vaginal creams (VersaBase), in electronic mortar and pestle plastic jars, is six months at both room temperature and refrigerated conditions.
• Pilot Study: Absorption and Efficacy of Multiple Hormones Delivered in a Single Cream Applied to the Mucous Membranes of the Labia and Vagina Gynecologic and Obstetric Investigation
• Progesterone 50 mg/g in VersaBase Cream US Pharmacist: A Jobson Publication

• Case Study: Absorption of Testosterone Cream Via Scrotal Delivery International Journal of Pharmaceutical Compounding

• Evaluation of the In Vitro Percutaneous Absorption of Progesterone, Testosterone, Estriol and Estradiol Topical Compounded Formulations 2021 SID Virtual Meeting

• Diltiazem Hydrochloride Compounded Cream | Official as of 01-Aug-2022

• Case Study: Testosterone Replacement Therapy in a Premenopausal Woman 2021 Annual Meeting of the North American Menopause Society

• 476. Evaluation of the In Vitro Percutaneous Absorption of Progesterone, Testosterone, Estriol and Estradiol Topical Compounded Formulations Journal of Investigative Dermatology
• 1120 In Vitro Percutaneous Absorption of Extemporaneously Compounded Estradiol Formulations Journal of Investigative Dermatology

• Evaluation of an Anhydrous Permeation-Enhancing Vehicle for Percutaneous Absorption of Hormones AAPS PharmSciTech
  Abstract
  Abstract: The efficiency and safety of hormone delivery through the skin partly depend on the appropriate choice of vehicle and the type of formulation. The present study reports the skin cytotoxicity, irritancy, and safety of a newly developed anhydrous permeation-enhancing base (APEB) and the percutaneous absorption of progesterone, testosterone, estriol, and estradiol in APEB formulations. Using the human skin EpiDerm model, cell death was not observed after 4 h of exposure to APEB and was 48% after 24 h, indicating its mild to non-irritating property. APEB did not change the expression level of skin cell proliferation markers including PCNA, MCL-1, iNOS, and NFκB proteins, and apoptosis was minimal after 8-h exposure. The in vivo skin irritation and sensitization evaluation of APEB using a Human Repeat Insult Patch Test showed no adverse reaction of any kind during the course of the study. These results indicate the safety of APEB on skin tissues. The hormone percutaneous absorption was performed using human cadaver abdomen skin tissues and the Franz diffusion system, and hormone concentrations were determined by ELISA. Absorption was observed as early as 2 h of application and accumulated after 24 h to 2851 ± 66 ng/cm2, 2338 ± 594 ng/cm2, 55 ± 25 ng/cm2, and 341 ± 122 ng/cm2 for progesterone, testosterone, estriol, and estradiol, respectively. A steady flux rate of absorption of the hormones was observed within 24 h of application. These results suggest that APEB can be used as a vehicle to deliver these hormones through the skin and into the bloodstream for hormone replacement therapy.
• In vitro Evaluation of the Percutaneous Absorption of Progesterone in Anhydrous Permeation-Enhancing Base Using the Franz Skin Finite Dose Model and Mass Spectrometry Archives of Dermatological Research
  Abstract
  Abstract: Progesterone is used for hormone replacement therapy through various routes of administration. This study was conducted to (a) evaluate the stability of progesterone in a proprietary anhydrous permeation-enhancing base (APEB) and the efficiency of its skin permeation, and (b) determine the appropriateness of mass spectrometry as a method of analysis for permeated progesterone. Using a proven stability-indicating ultra-performance liquid chromatographic method, the compounded hormone (100 mg progesterone/g APEB gel) was determined to be physically and chemically stable at room temperature for six months. Skin permeation analysis using the Franz skin finite dose model and mass spectrometry imaging showed an optical density of 1699 for the permeated progesterone compounded in APEB and 550 for the permeated progesterone in a water containing VBC, which is a statistically significant different (P = 0.029). The study suggests that APEB can be used as a compounding base for effective skin permeation of progesterone, and mass spectrometry is a reliable method for visualization and quantitative analysis of permeated progesterone.

• Case Study: Testosterone Replacement Therapy in a Premenopausal Woman 2021 Annual Meeting of the North American Menopause Society
• Evaluation of the In Vitro Percutaneous Absorption and Stability of Progesterone Topical Compounded Medications 20th International Conference for Restorative Reproductive Medicine
• Evaluation of the In Vitro Percutaneous Absorption of Progesterone, Testosterone, Estriol and Estradiol Topical Compounded Formulations 2021 SID Virtual Meeting
• In Vitro Percutaneous Absorption of Extemporaneously Compounded Estradiol Formulations 2023 SID Meeting

• Evaluation of Safety and Skin Irritancy of VersaBase Anhydrous HRT in Human Epidermis Model
• Evaluation of the in vitro Human Skin Percutaneous Absorption of Estriol and Estradiol in PCCA VersaBase® Anhydrous HRT
• Evaluation of in vitro Human Skin Percutaneous Absorption of Progesterone in VersaBase Anhydrous HRT
• Evaluation of in vitro Human Skin Percutaneous Absorption of Testosterone in VersaBase Anhydrous HRT

• Evaluation of the Efficacy and Stability of Compounded Pentoxifylline-Containing XemaTop™ for Psoriasis International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Psoriasis is an inflammation-mediated skin disorder for which an efficacious topical treatment is yet to be identified. A new compounded topical formulation containing 10% pentoxifylline in XemaTop base was recently developed for psoriasis. Prior to its use in humans, an in vitro evaluation was performed to determine its efficacy in attenuating molecular markers associated with psoriasis using a three-dimensional psoriasis tissue model. After 5 days of topical exposure to the formulation, the levels of inflammatory cytokines IL-1ß, IL-6, and GM-CSF decreased by 20%, 94%, and 96%, respectively. The production of pro-collagen type I and fibronectin essential for cellular proliferation was also significantly inhibited with a concomitant thinning of the epidermis. These results suggest that 10% pentoxifylline in XemaTop is efficacious in inhibiting the biomarkers associated with psoriasis. Pentoxifylline in XemaTop was stable within 91 days when stored under refrigerated or ambient conditions. These biochemical and stability studies suggest that 10% pentoxifylline in XemaTop may be evaluated now in psoriasis patients.
• In Vitro Evaluation of Naltrexone HCl 1% Topical Cream in XemaTop™ for Psoriasis Archives of Dermatological Research
  Abstract
  Abstract: Psoriasis is a multifactorial skin disease involving abnormal cell proliferation and inflammation; an efficacious topical treatment is yet to be identified. A formulation containing 1% Naltrexone HCl in XemaTop™ base was compounded, characterized and evaluated in vitro as a possible treatment for psoriasis. A three-dimensional psoriasis tissue model was exposed to the formulation for 2 or 5 days and analyzed for the level of markers of cellular proliferation, and inflammatory cytokine IL-6. Using immunohistochemical staining, the level of Ki67 protein significantly decreased in the drug-treated tissues. Western blot analysis showed 86% and 53% down-regulation of other proliferation markers PCNA and CYCLIN D1, respectively, after 5-day exposure. The pro-survival Wnt/β-catenin pathway was compromised as indicated by 57% decrease in the level of β-CATENIN and down-regulation of its down-stream targets including CYCLIN D1 (decreased by 53%), c-MYC (63%), c-JUN (92%) and MET (96%) proteins. Likewise, the PI3K/AKT/mTOR pathway was significantly inhibited by 1% Naltrexone HCl in XemaTop™, suggesting protein synthesis was affected. The production of IL-6 was inhibited by 70% in drug-treated tissues. These results suggest that the compounded drug is efficacious in down-regulating molecular markers associated with the pathogenesis of psoriasis. Low-dose Naltrexone in XemaTop™ was stable within 180 days when stored under refrigerated or ambient conditions. These results provide a basis for a clinical evaluation of 1% Naltrexone HCl in XemaTop™ in psoriasis patients.
• Management of Psoriasis with a XemaTop Topical Compounded Formula: A Case Report  International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Skin conditions such as psoriasis and eczema negatively impact the patient’s quality of life; the primary goal of topical treatments is to minimize the disease-specific symptoms. This case report discusses the management of two refractory psoriasis skin lesions in an adult male using a topical compounded formula. The psoriasis symptoms were assessed quantitatively using two validated research instruments, the Psoriasis Symptom Inventory, and an adapted Numeric Rating Scale. A qualitative assessment was also performed by evaluating the digital photographs taken by the patient during the course of treatment. The compounded formula containing zinc pyrithione, clobetasol propionate, and cyanocobalamin in the Professional Compounding Centers of America’s proprietary base PCCA XemaTop, applied topically for three weeks, significantly reduced the patient’s self-reported psoriasis symptoms and improved his overall condition by 81.2%. This successful case report is important evidence for healthcare professionals when considering new, innovative topical compounded formulas for managing skin conditions such as psoriasis and eczema.

• Hand-Foot Syndrome Induced by Chemotherapy
• Management of Psoriasis with a XemaTop Topical Compounded Formula: A Case Report  International Journal of Pharmaceutical Compounding
  Abstract
  Abstract: Skin conditions such as psoriasis and eczema negatively impact the patient’s quality of life; the primary goal of topical treatments is to minimize the disease-specific symptoms. This case report discusses the management of two refractory psoriasis skin lesions in an adult male using a topical compounded formula. The psoriasis symptoms were assessed quantitatively using two validated research instruments, the Psoriasis Symptom Inventory, and an adapted Numeric Rating Scale. A qualitative assessment was also performed by evaluating the digital photographs taken by the patient during the course of treatment. The compounded formula containing zinc pyrithione, clobetasol propionate, and cyanocobalamin in the Professional Compounding Centers of America’s proprietary base PCCA XemaTop, applied topically for three weeks, significantly reduced the patient’s self-reported psoriasis symptoms and improved his overall condition by 81.2%. This successful case report is important evidence for healthcare professionals when considering new, innovative topical compounded formulas for managing skin conditions such as psoriasis and eczema.

• Compounding for Atopic Eczema and Psoriasis 6th International Science of Nutrition in Medicine Conference (ACNEM)
• In Vitro Evaluation of Naltrexone HCl 1% Topical Cream in Xematop for Psoriasis 77th SID Annual Meeting

• Naltrexone Hydrochloride Compounded Cream | Official as of 01-Dec-2021