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By Maria Carvalho, PharmD, MRPharmS, PhD, Manager of PCCA Science
United States Pharmacopeia 43 – National Formulary 38
The United States Pharmacopeia (USP) was created over 200 years ago and, combined with the National Formulary (NF), is now the global leader in setting standards that help ensure quality and safety in medicines. It includes monographs for substances, products and compounded preparations. Monographs for compounded preparations describe formulas (ingredients and quantities), specific directions to correctly compound the particular preparation, packaging and storage information, labelling information, pH, beyond-use dates based on stability studies, and detailed assays (in the majority of monographs). The USP Compounding Compendium is a separate publication that includes sections from USP–NF that are relevant specifically for the practice of compounding.1
The latest versions of the USP (43rd edition) and NF (38th edition), as well as the corresponding USP Compounding Compendium, have recognized the importance of several proprietary PCCA bases by including a total of five monographs in their official texts that use them as vehicles. The PCCA bases perform consistently with formulations for patients needing extended stability data, and these monographs provide further validation of the versatility of our bases in compounded formulations. This USP–NF recognition is of great value for compounding pharmacists in the U.S. and worldwide who demand the highest quality standards for their compounded formulations. The same rigorous testing used for USP Compounded Preparation Monographs is performed on all of our FormulaPlus™ formulas, which are available to PCCA members with Clinical Services support.
The PCCA bases featured in the official compendia are in the table below.
USP–NF Compounded Preparation Monographs with PCCA Bases 1
Monograph
Proprietary PCCA Base
Page Number(s)
Clindamycin Hydrochloride Compounded Oral Solution
SuspendIt® (PCCA #30-4825)
481
Doxycycline Compounded Oral Suspension, Veterinary
Fixed Oil Suspension Vehicle (PCCA #30-4316)
495–497
Estriol Compounded Vaginal Cream
Emollient Cream™ (PCCA #30-3168)
499–500
Ondansetron Compounded Topical Gel
Lipoderm® (PCCA #30-3338)
539
Phenytoin Compounded Topical Gel
Spira-Wash® Gel (PCCA #30-4678)
547–548
U.S. Pharmacist
U.S. Pharmacist is a monthly journal dedicated to providing pharmacists with peer-reviewed clinical articles relevant to the full spectrum of pharmacy-practice settings. The journal includes an open-access column on pharmacy compounding written by contributing editor Loyd V. Allen, Jr., PhD, RPh. Proprietary PCCA bases have been featured in this column as well, namely VersaBase® Cream (PCCA #30-3641), Lipoderm (PCCA #30-3338) and PracaSil®-Plus (PCCA #30-4655) (see table below). The most recent publication, dated January 19, 2021, discusses a formula with baclofen, clonidine HCl, gabapentin and ketamine in Lipoderm. Lipoderm is described in this publication as “an elegant alternative to traditional Pluronic Lecithin Organogels (PLOs), having a smooth and creamy feel rather than the tacky feel of PLOs. It contains a proprietary liposomal component that may increase the permeation of a variety of actives. Lipoderm is a stable system that does not separate upon refrigeration and has great resiliency in the presence of ionic substances.”2 These independent formulas also provide further validation of the versatility of our bases in compounded formulations.
Compounding Formulas with PCCA Bases Published in U.S. Pharmacist
Publication Date
Formula
Issue
September 15, 2017
Progesterone 50 mg/Gm in VersaBase Cream
U.S. Pharmacist vol. 42, iss. 9, p. 47–48
November 20, 2018
Sertraline 4 mg/0.1 mL in Lipoderm
U.S. Pharmacist vol. 43, iss. 11, p. 47–48
October 16, 2019
Clotrimazole 2%, Ibuprofen 2%, Metronidazole 2%, Nifedipine 0.2%, and Dexpanthenol 3% in PracaSil-Plus
U.S. Pharmacist vol. 44, iss. 10, 48–CV
January 19, 2021
Baclofen 2%, Clonidine HCl 0.2%, Gabapentin 10%, and Ketamine HCl 5% in Lipoderm
US Pharmacist vol. 46, iss. 1, p. 44-45
For more information on the science behind PCCA’s proprietary bases, please consult the corresponding technical reports at pccarx.com/science. 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).
References
1. United States Pharmacopeial Convention. (2020). United States pharmacopeia and national formulary (USP 43rd ed. & NF 38th ed.). https://www.uspnf.com/
2. Allen, L. V., Jr. (2021). Baclofen 2%, clonidine HCl 0.2%, gabapentin 10%, and ketamine HCl 5% in Lipoderm. U.S. Pharmacist, 46 (1), 44–45. https://www.uspharmacist.com/article/baclofen-2-clonidine-hcl-02-gabapentin-10-and-ketamine-hcl-5-in-lipoderm