THE PCCA BLOG

Leveraging PCCA Science to Benefit Physicians & Patients

Wed, 25 May 2022 15:09:42 GMT

Fabiana Banov, RPh, MS, PCCA Senior Formulation Pharmacist

PCCA Science, a division of our Research & Development department, is made up of pharmacists with real-world experience who diligently work to provide scientific studies and scholarly articles curated specifically for compounding pharmacists. With easy access to more than 300 published articles at PCCA Science, pharmacists can quickly provide evidence-based research and scientific data to physicians. Articles are categorized by Scientific Publications for a specific base, and by Formula Plus™ stability studies on relevant active ingredients.

Our Science team focuses on publishing scientific case studies using PCCA proprietary products. Case studies are extremely valuable, show evidence-based results and how compounded therapies help fill the unique needs of a unique patient. Case studies are also a great way to initiate conversations with physicians, as well as to clarify and show the impact a compounded formula had on a challenging health issue.

Our Science team also helps compounding pharmacists develop and potentially publish case studies using validated research tools. In fact, we want you to collaborate with PCCA Science and turn your patients’ success stories using PCCA products into case studies.

All you need to do is complete the Case Studies form, which is accessed on the PCCA Member website/Science/ Initiate Case Study or PCCA Member website/Resources/Documents/Search document number 99237. After you submit the case study request, a member of our Science team will contact you and explain all steps, including what is needed from you and what you can expect from our Science team.

PCCA Science does the heavy lifting—from supplying consent forms and questionnaires to conducting research and evaluations—for accepted case studies. If your study is accepted and published, you and the doctor may have the opportunity for your and the prescribing doctor’s names included with study authors.

Now more than ever, case studies are vital to preserving the compounding industry’s integrity, reputation and future. In addition to publishing evidence-based research and scientific data for physicians, case studies may have a positive impact on federal and state regulations and work to ensure patients maintain access to personalized medications.

For additional information, please contact our Science team at pccascience@pccarx.com

Glycopyrrolate Lollipops for Adults and Topical Fluoxetine for Cats: New Case Studies

Wed, 26 Jan 2022 19:11:16 GMT

By Maria Carvalho, PharmD, MRPharmS, PhD, Manager of PCCA Science

Compounding case studies describe successful patient treatments and provide scientific evidence to support the safety and efficacy of compounded medications. When case studies are published in peer-reviewed journals, pharmacists and clinicians worldwide become aware of innovative ways to treat their patients. One case study alone may improve the lives of many patients. That’s why we on the PCCA Science team work with compounders around the world to develop clinical case studies and publish them.

PCCA member Dr. Kelechi Agbi recently published two case studies featuring PCCA Sorbitol Lollipop^™ base in the International Journal of Pharmaceutical Compounding. Researchers at PCCA’s United Kingdom location also completed a case study on two veterinary patients who were successfully treated with a Lipoderm^® formula. You can find summaries of these studies below. More journal articles related to compounding will soon be published — stay tuned for more PCCA Science updates here on The PCCA Blog!

Glycopyrrolate Lollipops for Drooling in Two Adults

Study : Glycopyrrolate Sorbitol Lollipops for Drooling: Two Case Reports

Authors : Kelechi E. Agbi (Agbi’s Compounding Pharmacy, Pikesville, Maryland), Maria Carvalho and Fabiana Vieira-Banov (PCCA, Houston, Texas)

Publication : International Journal of Pharmaceutical Compounding, 25(6), 464-467

Summary : A patient with dementia and a patient with cancer both experienced persistent drooling, an issue that negatively affected their quality of life. They were both prescribed glycopyrrolate 0.5 mg sorbitol lollipops. During treatment, each of them experienced substantial decreases in the severity and frequency of drooling without any adverse effects. These two case reports demonstrate the safety and efficacy of compounded glycopyrrolate lollipops for managing excessive salivation.

For more information on the technology behind the base used in this study, visit the PCCA Sorbitol Lollipop product page on PCCA’s website.

Topically Applied Fluoxetine for Behavioral Issues in Two Cats

Study : Veterinary: Behaviour Disorders in Cats

Author : PCCA United Kingdom

Publication : PCCA Website (PCCA Document #99918)

Summary : Two cats, Charlie and Isobelle, tended to urinate and defecate in inappropriate locations around their house in the absence of their owner. These behavior issues, commonly attributed to separation-related problems, happened up to 10 times a day. Their veterinarian prescribed fluoxetine as tablets and as an oral liquid, but the cats refused both dosage forms. The veterinarian then prescribed a permeation-enhancing topical compounded medicine (fluoxetine 40 mg/Gm in Lipoderm) to be applied 0.1 mL inside the ear of the cats once daily. Following one month of treatment, the cats were no longer showing signs of emotional distress, and their behavior and wellbeing improved considerably.

For more information on the technology behind the base used in this study, visit the PCCA Lipoderm product page on our website.

The full list of PCCA case studies, and many others scientific publications, is available on the PCCA Science webpage under “ Scientific Publications .”

How We Can Help You Develop Your Own Case Study

Compounding pharmacists are on the therapeutic front lines every day and commonly hear success stories from their patients. Don’t miss the opportunity to share these stories! PCCA Science provides our members with full support in developing and writing clinical case studies. For more information on how to start a case study with us, please visit the PCCA Science webpage and click “ Initiate Case Study ” or contact us at PCCAScience@pccarx.com.

Also on The PCCA Blog: Scientific Posters Supporting the Safety and Efficacy of Compounds

Maria Carvalho, PharmD, MRPharmS, PhD, is the manager of PCCA Science. She is a certified pharmacist in Portugal and the United Kingdom with a PhD in pharmaceutical compounding from the University College of London. Maria has worked in community pharmacy, hospital pharmacy and the pharmaceutical industry in Europe and the United States. Maria has authored and co-authored many scientific publications, including the book Compounding Practices in Europe (ISBN-10:149236925X).

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.

Recent Product Development, Clinical Research and Formulation Studies from PCCA

Wed, 04 Aug 2021 13:34:56 GMT

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