By Gus Bassani, PharmD, PCCA Chief Scientific Officer

The last 18 months were unique and challenging to say the least. Despite the pandemic and the disruption it caused, I am incredibly proud of our Research and Development (R&D), Formulation Development, PCCA Science and Clinical Services teams’ accomplishments.

We were able to advance several ongoing R&D projects related to new products, clinical research and formulation studies, while seamlessly continuing to field our member pharmacies’ technical questions via our decentralized Clinical Services team. Our scientists remained in the labs and separated into split shifts to mitigate risk. This all resulted in us getting a lot done in the face of significant uncertainty!

With much excitement, last year we finalized development and launched our new product, Ellage^®, an anhydrous vaginal base with mucoadherent and self-emulsifying properties, giving compounders the ability to extend beyond-use dates (BUDs) and provide better delivery and adhesion to the vaginal mucosa. Feedback on this new delivery system has been incredibly positive.

Because of the pandemic, you may not be aware that our PCCA Science team published a terrific clinical study evaluating the efficacy of dexamethasone in our base MucoLox^™ as a treatment for oral lichen planus (OLP). The study was supported by PCCA and performed through the Division of Oral Medicine & Dentistry at Brigham & Women’s Hospital in Boston as well as the Harvard School of Dental Medicine. It was published in the widely read journal Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. The study concluded that “a dexamethasone 0.1 mg/mL solution in MucoLox was more effective for the management of OLP compared with the commercial dexamethasone 0.1 mg/mL solution.”¹ A follow-up study is now underway with the same principal investigator at the University of California, San Francisco, looking at the impact of this MucoLox preparation on oral inflammatory ulcerative diseases. There is also an ongoing MucoLox study being conducted by the Levine Cancer Institute in North Carolina, which is focused on oral mucositis. The ultimate goal of these studies is to generate data that will benefit patients and show the value that pharmacy compounding can bring to patients with these conditions.

Our Formulation Development team grew our library of BUD studies under the FormulaPlus^™ umbrella, finalizing 26, many of which were bracketed. This past year, our dedicated team of scientists created 307 new formulas and revised 3,959, adding significant value for PCCA members. This is an impressive feat, especially in light of the pandemic conditions.

Behind the scenes, PCCA R&D has been in the process of changing several of our bases’ preservative systems in response to growing preferences regarding the avoidance of methylisothiazolinone in topical products. We completed this work on VersaBase^® Cream last year, which was a huge multi-year undertaking, since we had to reperform all of the associated BUD studies in addition to the extensive numbers of microbiological tests. As consumer and practitioner preferences change, we must adapt as well. The R&D team has done a wonderful job navigating this project.

The PCCA innovation pipeline is currently full of projects and research intended to make a difference in patients’ lives, and to put pharmacists in a better position to maintain an active role in personalized medicine. The world of pharmaceutical compounding has seen an abundance of change, but there are still patient needs unmet by commercially available options. Additionally, the science surrounding pharmacogenomics, metabolomics and biomarkers-of-response is accelerating the development of therapies that are precise and individualized. We envision pharmacists who are trained in compounding and equipped with the necessary formulation technology to be a critical component of providing these therapies in the future. With this vision in mind, our scientific teams are keeping their “hands on the plow” and pushing forward with purpose!

Also on The PCCA Blog: USP-NF and U.S. Pharmacist Featuring Proprietary PCCA Bases

Gus Bassani, PharmD, PCCA Chief Scientific Officer, has been with PCCA since September 2002. Prior to that, he was a formulation pharmacist in the product development lab of a veterinary pharmaceutical company. He has worked in multiple pharmacy practice settings in Alaska, Iowa and Kansas, and has taught extemporaneous compounding principles to pharmacy students in Drake University's Pharmaceutics Laboratory course. Gus earned his Doctor of Pharmacy degree from the Drake University College of Pharmacy and Health Sciences. He is a member of the 2020–2025 United States Pharmacopeia Compounding Expert Committee, and has been on the committee since 2010. He served on the 2012–2014 Drake University College of Pharmacy and Health Sciences National Advisory Council. He is a member of the American Pharmacists Association (APhA), Alliance for Pharmacy Compounding (APC), American Association of Pharmaceutical Scientists (AAPS) and National Community Pharmacists Association (NCPA).

Reference

1. Villa, A., Sankar, V., Bassani, G., Johnson, L. B., & Sroussi, H. (2020). Dexamethasone solution and dexamethasone in MucoLox for the treatment of oral lichen planus: A preliminary study.Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 129(6), 585–590. https://doi.org/10.1016/j.oooo.2020.02.014