Nifedipine in compounded oral and topical preparations

Area of Science:

• Pharmaceutical Compounding
• Drug Stability
• Formulation Science

Background:

• Nifedipine is a medication susceptible to degradation when exposed to light.
• Understanding optimal compounding conditions is crucial for ensuring medication efficacy.
• Previous studies have not fully elucidated nifedipine's stability during compounding.

Purpose of the Study:

• To evaluate nifedipine oral and topical compounding formulas and procedures.
• To determine the impact of different drug sources and light exposures on nifedipine preparations.
• To identify optimal compounding conditions for nifedipine oral and topical formulations.

Main Methods:

• Compounded topical preparations using Plastibase 50 W with two drug sources and four light exposures.
• Compounded oral preparations with two drug sources, two light exposures, and four suspending vehicles.
• Assessed topical and oral formulations for potency, uniformity, and usability characteristics.

Main Results:

• Preparations compounded entirely under gold-shaded fluorescent light using nifedipine powder USP achieved 90-110% potency.
• Exposure to ambient or red-shaded fluorescent light resulted in sub-potent nifedipine preparations.
• Nifedipine powder USP was a suitable drug source, while commercial soft-gelatin capsules were problematic.

Conclusions:

• Nifedipine is sensitive to specific light wavelengths, leading to rapid degradation.
• Compounding nifedipine requires protection from light, with gold fluorescent lighting being effective.
• Nifedipine powder USP is the preferred source for compounding stable nifedipine preparations.