THE PCCA BLOG

PCCA SuspendIt Presented at International Scientific Conferences

Wed, 09 Nov 2022 13:10:54 GMT

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

PCCA SuspendIt is a contemporary suspending vehicle that offers convenience and dosing flexibility for compounded medications. Throughout the years, the stability of standardized formulations for SuspendIt oral liquids has been studied and validated by PCCA, Eagle Analytical Services and other institutions, such as the College of Pharmacy at Xavier University of Louisiana (XULA).

PCCA SuspendIt is now featured in several United States Pharmacopeia (USP) monographs and it is currently one of the most studied oral vehicles in the compounding industry.

This year, the 80^thFIP (International Pharmaceutical Federation) World Congress of Pharmacy Congress was held in Seville, from September 18-22, in collaboration with the 22^nd Spanish National Pharmacy Congress. Together, there were more than 7,000 participants from over 100 countries attending both congresses, an impressive turnout!

To mark the special celebration of the 80^th FIP World Congress, PCCA presented a scientific poster summarizing the validated stability studies for 40 pediatric oral liquids. This was a great opportunity to demonstrate the science behind PCCA SuspendIt and the quality of the validated stability studies. Our research attracted a lot of attention from pharmacists worldwide who recognized the need to prepare palatable, uniform and stable oral liquids, particularly for pediatric patients.

PCCA members can access Scientific Publications and Formula Plus™ Studies on the PCCA Science webpage. PCCA members can also contact us at pccascience@pccarx.com.

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 has authored and co-authored many scientific publications, including the book Compounding Practices in Europe (ISBN-10:149236925X).

PCCA Science Update - Benefits of Collaboration

Wed, 03 Aug 2022 13:01:00 GMT

by PCCA

Compounding pharmacist and owner of Agbi’s Compounding Pharmacy in Pikesville, Maryland, Kelechi Agbi, PharmD, BCGP, RPh and author of the 2021 International Journal of Pharmaceutical Compounding article, ‘Glycopyrrolate Sorbitol Lollipops for Drooling: Two Case Reports’ discusses his experience and the value he found collaborating with PCCA Science.

What was your reason for developing and executing case studies with PCCA Science?

To demonstrate with consistency the indispensable and unique contribution compounding pharmacists make in the lives of patients and for the healthcare system as a whole. Also, so we could make the information provided by the case studies available to clinicians all over the world for the betterment and benefit of patients. Finally, we wanted to demonstrate the reliability and quality of PCCA pharmaceutical resources.

How have you incorporated the case studies into conversations with practitioners?

Since all of my case studies demonstrate alternative and nonconventional ways of treating diseases, my conversation with practitioners hinges on the fact that my pharmacy is happy to provide physicians and healthcare practitioners in general with alternative therapies based on sound clinical studies when desired clinical outcomes are not achievable by conventional modalities. Nevertheless, we help with conventional therapies as well.

How have you used these studies within your pharmacy practice?

We display copies of the studies in the pharmacy for our patients to witness the uniqueness and quality of practice and services.

What was the impact of these studies on your business growth?

The studies have helped us grow our business by strengthening our confidence based on our previous professional achievements. They have given us exposure— both local and distant clinicians have referred patients to us. With those referrals we have experienced about 20% increase in business growth from the exposure and awareness generated through the studies.

We invite 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, accessed on the PCCA Member website/Science/ Initiate Case Study, or 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 our Science team needs from you and what you can expect from our Science team.

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

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.

LDN Study, Extended BUDs and More from PCCA Science

Mon, 27 Jan 2020 16:42:48 GMT

By Yi Liu, PharmD, PhD, PCCA Research Pharmacist

Peer-reviewed journals have recently published a lot of PCCA’s original research as well as that of independent researchers studying PCCA products. We have been investigating novel therapies, extending beyond-use dates (BUDs) for compounded formulations, evaluating pharmacy compounding equipment and much more. Here is a brief summary.

Naltrexone in Dermatology
The journal Archives of Dermatological Research recently published our study entitled “In Vitro Evaluation of Naltrexone HCl 1% Topical Cream in XemaTop™ for Psoriasis.” We investigated the mechanism of action, in vitro efficacy and stability of this topical cream containing low-dose naltrexone (LDN) in PCCA’s base XemaTop for the treatment of psoriasis. This article provides a basis for potential psoriasis treatment options and may be useful to clinicians who are interested in LDN as well. PCCA members who would like more information about this study can contact PCCA Science for the full text of the article or further discussion.

We were also honored to have this novel research in psoriasis therapy selected as an oral presentation at the 79th International Pharmaceutical Federation World Congress of Pharmacy and Pharmaceutical Science, held in Abu Dhabi, United Arab Emirates, in September 2019. Suki Pramar, PhD, from our Clinical Services team presented the data to a full auditorium. The presentation slides are publicly available online.

Stability of APIs in SuspendIt^®
In its November/December 2019 issue, The International Journal of Pharmaceutical Compounding published a bracketed stability study of amlodipine besylate in SuspendIt, PCCA’s proprietary suspending agent, granting an extended BUD for the formulation in the study. This follows previously published stability studies of common active pharmaceutical ingredients (APIs) in this base. These previous studies have established extended BUDs for naltrexone hydrochloride, ursodiol, trimethoprim and sulfadiazine, spironolactone, fluconazole and clindamycin in SuspendIt.

Minimizing Powder Exposure for USP <800>
To help comply with USP General Chapter <800> and explore more strategies for compounders, Chad Hutson, PharmD, PCCA Clinical Compounding Pharmacist, and A. J. Day, PharmD, PCCA Vice President of Clinical Services, have performed a study to evaluate the efficacy of a containment ventilated enclosure (CVE). They found strong evidence that a properly calibrated CVE for containment of hazardous aerosol-generating compounding activities is effective in minimizing powder chemical exposure to the compounder. This research is also available in the November/December 2019 issue of The International Journal of Pharmaceutical Compounding with the title “Evaluation of Containment Ventilated Enclosure Performance in Absence of Negative Pressure Containment Secondary Engineering Control.”

Case Study: Pain Management for Achilles Tendonitis
We in PCCA Science are still diligently working with members on case studies. On the PCCA Science webpage, we recently published a new case study, “Achilles Tendonitis: Pain Management by Compounding,” submitted by Jim Perry, RPh, from District Drugs & Compounding Center in Rock Island, Illinois. The study evaluated the effectiveness of diclofenac and lidocaine in Lipoderm® for two patients with Achilles tendonitis.

New Independent Compounding Research
Outside PCCA, independent researchers have constantly presented data of PCCA products that are consistent with our findings, which further demonstrate the quality and reliability of our products. In the November/December 2019 issue of The International Journal of Pharmaceutical Compounding, a study validated the compatibility of two PCCA flavors in an omeprazole oral liquid. In another study published in that issue, gabapentin in a Lipoderm formulation once again showed fast release and high skin permeation. Lipoderm was recommended by the authors as “the most practical option for compounding.”¹

PCCA member pharmacies who are interested in conducting and publishing research with PCCA are welcome to contact PCCA Science at pccascience@pccarx.com.

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.

Reference
1. Shakshuki, A., & Agu, R. U. (2019). Compounded topical gabapentin for neuropathic pain: Does choice of base affect efficacy? The International Journal of Pharmaceutical Compounding, 23(6), 496–503. Retrieved from https://www.ijpc.com/

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.