COMPOUND WITH CONFIDENCE: PCCA Membership, $795/month.
Stay current on PCCA news and events, market trends, and all things compounding!
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 ”
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.