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by Sam Hamburger, PharmD Candidate, PCCA Clinical Services Intern, and Mark Gonzalez, PharmD, PCCA Clinical Compounding Pharmacist
One of the most valuable benefits of PCCA membership is access to our knowledgeable Research & Development department and their compounding base innovations. Their creativity has led the industry and provided resources that benefit thousands of patients every day. This post focuses on a powerful base launched in 2023, EctoSeal P2G, and its application in one of the most common dermatological conditions — nail fungus (onychomycosis).
EctoSeal P2G (powder to gel) was developed by the PCCA R&D department and released in 2023. It is one of the most innovative and clinically versatile bases in the compounding industry, with seemingly limitless potential. The base itself is available as a powder that can be compounded with a wide variety of active pharmaceutical ingredients (APIs) and dispensed in one of three unique dosage forms: a powder, a powder for reconstitution or a hydrogel. Each dosage form has unique and versatile therapeutic possibilities. Regardless, the end goal of this base is to form a protective film over the affected area, delivering the API while simultaneously shielding the area and enhancing the skin’s local microbiome. It is also easily removed by simply rinsing with water, which causes the film to revert to a liquid gel that will simply wash off.
As a compounder, you are by definition a creative individual. Imagine the possibilities of compounding a preparation that creates a microbiome-enhancing protective film — one that easily washes off with water, easing the discomfort experienced by wound patients during dressing changes or Polyox bandage removal. Coupled with the imagination and ingenuity of PCCA members, we have seen incredible advances beyond wound care in conditions such as acne, diaper rash, excoriated eczema, veterinary infections, vaginal/rectal lesions and most recently, nail fungus (onychomycosis).
For decades, compounders have formulated prescriptions for use on patients with onychomycosis. The condition occurs in 10 percent of the general population, 20 percent of persons older than 60 years and 50 percent of those older than 70 years. Although caused by a variety of organisms, most cases are created by dermatophytes, a pathogenic fungus that causes ringworms and other diseases.1 Topical preparations have often been preferred over oral therapies due to a lower side effect profile.
The vehicle of choice to deliver compounded antifungal agents has traditionally been dimethyl sulfoxide (DMSO) because of its ability to solubilize many APIs and penetrate various tissues. For antifungal preparations to be effective, transungal (through the nail) penetration is crucial to eliminate an infection that resides in the nail and nail bed.
Recognizing EctoSeal P2G’s excellent film-forming property, the PCCA Science team tested and measured the vehicle’s drug delivery potential in the nail using two PCCA formulas containing EctoSeal P2G, then compared those formulations with a standard formula involving APIs and DMSO alone. Five volunteers who met study eligibility criteria provided nail clippings, which were coated with one of the following compounded formulations:
After the compounds were applied to the nail clippings and allowed to dry for 48 hours, the clippings were washed to remove any drug residue. Ultra-Performance Liquid Chromatography (UPLC), a liquid chromatography technique that uses high pressure and new column technologies to separate compounds in complex mixtures, was used to measure the amount of drug in the pulverized nail clippings. When compared to the DMSO solution delivery, both EctoSeal P2G formulations resulted in much higher concentrations of drug (approximately 50 percent more) within the nail plate. This proves that an EctoSeal P2G/DMSO mixture is more effective at delivering drugs into the nail than DMSO alone.2
Compounders now have reliable data to present to dermatologists, podiatrists and general practitioners who have not found success with commercially available options for onychomycosis. Marketing this study may also broaden the practitioner’s imagination regarding the use of the film-forming possibilities of EctoSeal P2G. As compounders, we can take advantage of this data and innovative base vehicle to promote the endless opportunities that compounding can provide to solve medication problems and potentially improve patient outcomes.
Build and market your practice by promoting EctoSeal P2G:
PCCA members may learn more about EctoSeal P2G by watching a free webinar. PCCA members with clinical service access may contact our Clinical Services team for additional information on EctoSeal P2G and other compounding concerns. Members without clinical services access can learn how to connect with the experts on our Clinical Services team HERE.
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These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.