Quality assessment of nifedipine cream compounded by retail pharmacies in Tehran

• Published in: Journal of pharmaceutical health services research 2019-09, Vol.10 (3), p.359-364
• Main Authors: Tavakoli Moghaddam, Noushin, Mahboubi, Arash, Afshar, Minoo
• Format: Article
• Language: English
• Subjects: compounding; Drug stores; extemporaneous; microbial limit test; nifedipine; Pharmacy; potency; Prescriptions
• ISSN: 1759-8885; 1759-8893
• DOI: 10.1111/jphs.12269

Objectives It has been shown that nifedipine cream 0.5% is effective in the treatment of anal fissure and in reducing facial wrinkles. However, no commercially manufactured formulation of this product is available in some countries and prescriptions for the medication need to be extemporaneously compounded by retail pharmacies. So, the aim of this study was to evaluate the quality of the compounded nifedipine cream 0.5%. Methods Twenty‐one compounding pharmacies within Tehran area were randomly included in this study. A physician wrote the prescriptions for compounded nifedipine in dexpanthenol cream (0.5%) for fictitious patients, with two refills allowed per prescription. The extemporaneous products were analysed for potency and microbial limit using validated methods. Key findings There was a significant variability both within and between pharmacies with respect to the potency of the compounded products. By contrast, no microbial contamination was detected in these products. Of 63 prescriptions, nifedipine concentration of 21 products (33.33%) was within ±20% of the prescribed dose. Thirty‐ nine (61.90%) were sub‐potent, which ranged in potency from 24.33–77.57%. One pharmacy provided products with essentially no nifedipine. Conclusion Compounded nifedipine obtained from pharmacies in this study did not raise safety concerns when assessed for microbial contamination. However, compounded products may be misbranded, which may negatively impact the management of anal fissure and facial wrinkles.