New Peer-Reviewed Journal Articles on MucoLox, Lipoderm and More

Wed, 22 Jul 2020 15:59:05 GMT

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

A lot has changed since our last publication update in January — research institutions worldwide are struggling to keep studies going amid lockdowns, remote working and supply disruptions. Despite the current circumstances, PCCA Science has been honored with great publications in peer-reviewed scientific journals. Here’s what we’ve got so far in 2020:

Dexamethasone and MucoLox^™

“ 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 (Impact Factor 1.601)

This is a randomized, phase II clinical study that compares the safety and efficacy of dexamethasone 0.1 mg/mL solution with and without MucoLox for the treatment of oral lichen planus (OLP). The results showed that dexamethasone in MucoLox was more effective for the management of OLP compared with dexamethasone alone. This study was conducted by researchers at Brigham and Women’s Hospital (Boston, Massachusetts) in collaboration with Gus Bassani, PharmD, PCCA Chief Scientific Officer.

Naltrexone and PracaSil^®-Plus

“ A Topical Naltrexone Formulation for Surgical Wound Healing: A Case Report ”

Journal of Cosmetic Dermatology (Impact Factor 1.621)

This case report discusses the effectiveness of a topical compounded formulation (naltrexone hydrochloride 1%, aloe vera 0.2% and β-glucan 0.2% in PracaSil-Plus ) in wound healing. The patient underwent hand surgery and, following two weeks of topical treatment, the wound was completely healed, the hand function was fully recovered and there was no abnormal scarring. PCCA member Jasper Drug Store (Jasper, Georgia) conducted this study in collaboration with PCCA Science and Sebastian Denison, RPh, FAARM (candidate), PCCA Clinical Compounding Pharmacist.

Pentoxifylline and XemaTop™

“ Evaluation of the Efficacy and Stability of Compounded Pentoxifylline-Containing XemaTop for Psoriasis ”

International Journal of Pharmaceutical Compounding

This in vitro study evaluates the efficacy of a compounded topical formulation containing 10% pentoxifylline in XemaTop using a three-dimensional psoriasis tissue model. The study also presents the physicochemical stability of pentoxifylline 5% and 15% in XemaTop over three months. The results obtained suggest that the topical formulation is efficacious in inhibiting the biomarkers associated with psoriasis. This study was conducted by PCCA’s Research and Development team. PCCA members can contact us at pccascience@pccarx.com to access the full text of this journal article.

Multiple APIs and Lipoderm^®

“ 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

This journal article by external researchers presents a case series of topical ketamine with other active pharmaceutical ingredients (APIs) in Lipoderm that successfully controlled pain and reduced opioid dosing in cancer patients.

“ Hair Regrowth in 2 Patients with Recalcitrant Central Centrifugal Cicatricial Alopecia after Use of Topical Metformin ”

Journal of the American Academy of Dermatology (JAAD) Case Reports

This case series by external researchers discusses the visible hair regrowth in two patients with alopecia following the topical application of metformin 10% in Lipoderm.

Other Scientific Publications

“ Clinical Efficacy of a Topical Compounded Formulation in Male Androgenetic Alopecia: Minoxidil 10%, Finasteride 0.1%, Biotin 0.2%, and Caffeine Citrate 0.05% Hydroalcoholic Solution ”

International Journal of Pharmaceutical Compounding

This is a prospective case series that investigates the clinical efficacy and patient satisfaction of a topical compounded formulation (minoxidil 10%, finasteride 0.1%, biotin 0.2% and caffeine citrate 0.05% hydroalcoholic solution) in male androgenetic alopecia. Although moderate, the clinical improvements were visually noticeable, as most patients had thicker, more voluminous hair; improved scalp coverage; and improved general hair appearance. PCCA member VLS Pharmacy & New Drug Loft (New York, New York) conducted this study in collaboration with Marotta Plastic Surgery Specialists (Smithtown, New York) and Maria Carvalho, PharmD, MRPharmS, PhD, PCCA Science Manager.

In addition to these peer-reviewed journal articles, PCCA’s Research and Development team has published another technical report on VersaBase^®Anhydrous HRT to complete the series of in vitro skin permeation studies on this base: “ Evaluation of the in Vitro Human Skin Percutaneous Absorption of Estriol and Estradiol in PCCA VersaBase Anhydrous HRT .” Some of the results are below.

Across donor summary: Mean flux rate of estriol (ng/cm²/hr) in two compounded formulations during 24 hours diffusion. Absorption values were reported at midpoint of sample collection (e.g. mean flux rate at 18-hour time-point represents the rate of flux during 12 to 24 hours). Results were plotted as mean ± standard error.

Across donor summary: Mean flux rate of estradiol (ng/cm² /hr) in two compounded formulations during 24 hours diffusion. Absorption values were reported at midpoint of sample collection (e.g. mean flux rate at 18-hour time-point represents the rate of flux during 12 to 24 hours). Results were plotted as mean ± standard error.

PCCA member District Drugs & Compounding Center (Rock Island, Illinois) also worked with PCCA Science on a very interesting Lipoderm case study: “ Topical Pain Relief for Degenerative Disc Disease .” Following six months of treatment with a topical pain cream containing baclofen 2%, bupivacaine hydrochloride 1% and ketoprofen 10% in Lipoderm, the patient reported a decreased level of pain and improved daily functionality.

PCCA members, would you like to show prescribers and patients the effectiveness of your compounds? PCCA Science can work with you to develop a publishable case study. Learn more in our blog post “ PCCA Science Update: Share Your Case, Share Your Knowledge .”

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 (UCL). Maria has worked in community pharmacy, hospital pharmacy and the pharmaceutical industry in Europe and the United States. She was a teaching assistant at the UCL School of Pharmacy (UK) and an invited teacher at the University Fernando Pessoa (Portugal). Maria is also a reviewer of compounding articles for peer-reviewed journals and has authored or co-authored several scientific publications.

PCCA Science Update: Share Your Case, Share Your Knowledge

Wed, 31 Jul 2019 14:22:43 GMT

By Yi Liu, PharmD, PhD, PCCA Research Pharmacist

PCCA never stops initiating and working with others on a variety of research projects, keeping up with the cutting-edge compounding technology, sharing evidence-based knowledge, and turning innovative ideas into practice. PCCA Science is here not only to present the scientific research conducted by our very own Research and Development, Formulation Development and Clinical Services teams, but also to support PCCA member pharmacies in preparing and publishing their clinical findings, ultimately to promote our profession and meet more patients’ needs.

Currently, PCCA has ongoing research activities at different levels ranging from cell biology to patient studies. We combine knowledge from basic, foundational science all the way to advanced clinical practice. To that end, we are inviting PCCA members to work with us: Tell us about your patient’s story, your plan for a potential study or even your innovative idea. PCCA Science will work with you to translate it into a scientific publication to spread the benefits to more patients while promoting your practice. Contact us at pccascience@pccarx.com.

Check our PCCA Science webpage often and stay tuned to our latest publications on PCCA products, compounded therapies and case studies. Here are recent publications:

Recent Publications

Pediatric Compounding Pharmacy: Taking on the Responsibility of Providing Quality Customized Prescriptions
Journal article by PCCA, published in Children (May 2019). Read the full text here.

Compounded Gabapentin for Neuropathic Pain: Stability and Beyond-Use Date (BUD) in Some Commonly Used Bases
Journal article by independent researchers using PCCA’s base Lipoderm^®, published in the Journal of the American Pharmacists Association (July-August 2019). Read the abstract here.

Veterinary: Feline Patient Treated with Transdermal Gabapentin
Case study by a veterinary practice, published by PCCA Science. Read it here.

In Vitro Evaluation of Naltrexone HCl 1% Topical Cream in XemaTop for Psoriasis
Conference poster and abstract by PCCA, presented at the Society for Investigative Dermatology 77th Annual Meeting in Chicago, Illinois, May 8–11, 2019. Access the poster here and the conference abstract (#691) here.

Yi Liu, PharmD, PhD, is a research pharmacist in the Research and Development department at PCCA. She joined PCCA as a clinical pharmacy researcher in the Clinical Services department in 2018 and started her current role in 2019. Yi graduated from Ohio University with a PhD in molecular and cellular biology in 2012. She also worked as a postdoctoral research fellow in the Houston Methodist Research Institute for three years prior to starting pharmacy school. Yi received her PharmD from the University of Houston College of Pharmacy in 2019.

THE PCCA BLOG

New Peer-Reviewed Journal Articles on MucoLox, Lipoderm and More

PCCA Science Update: Share Your Case, Share Your Knowledge