Premium
Variability of compounded topical 0.2% nifedipine formulations
Author(s) -
Barak Nir,
Rice Howard,
Kamsler Ariel
Publication year - 2019
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/jppr.1470
Subject(s) - compounding , nifedipine , medicine , potency , medical prescription , pharmacy , pharmacopoeia , pharmacology , family medicine , alternative medicine , calcium , biochemistry , chemistry , pathology , in vitro
Background This aim of the study was to conduct a quality analysis of compounded formulations of topical nifedipine 0.2% obtained from retail compounding pharmacies. Methods Nifedipine preparations were purchased in triplicate (refills two weeks apart) from nine commercial compounding pharmacies and assessed for: (1) label and information in compliance with regulations; (2) content homogeneity, determined by content assessment of samples from the top, middle and bottom of each preparation and microscopic assessment of crystals; (3) prescription uniformity (i.e. determining the content of each of the refills compared with the first prescription dispensed); and (4) microbiological contamination. Results Only two providers labelled the product as a compounded product, and only one compounder included a lot or batch number and storage instructions. Of the 81 samples (from nine pharmacies) analysed, only 22 complied with the US Pharmacopoeia standard for potency being 90–115% of label claim; the lowest potency detected was 48.5% and the highest was 157.5%. Conclusion Patients prescribed topical 0.2% nifedipine received compounded formulations that were incorrectly or inappropriately labelled and with considerable variability in potency and content uniformity.