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In vitro dissolution studies on nifedipine capsules

A C Mehta1, S Hart-Davies, E A Kay

  • 1Department of Pharmacy, General Infirmary, Leeds, Yorkshire, U.K.

Journal of Clinical Pharmacy and Therapeutics
|August 1, 1995
PubMed
Summary
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Dissolution testing of nifedipine capsules from eight suppliers showed satisfactory performance for all fourteen products. All nifedipine formulations achieved over 80% drug release within 20 minutes in simulated gastric fluid.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Pharmacokinetics

Background:

  • Nifedipine is a crucial calcium channel blocker for managing hypertension and angina.
  • Ensuring consistent in vitro drug release is vital for predictable in vivo therapeutic outcomes.
  • Generic nifedipine products must demonstrate bioequivalence to innovator products.

Purpose of the Study:

  • To evaluate the in vitro dissolution performance of nifedipine capsules from multiple suppliers.
  • To compare the dissolution profiles of 5 mg and 10 mg nifedipine capsules.
  • To assess compliance with regulatory dissolution specifications.

Main Methods:

  • In vitro dissolution testing was performed on 14 nifedipine capsule products (5 mg and 10 mg) from 8 different suppliers.

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  • The rotating paddle apparatus was utilized according to established pharmacopeial methods.
  • Simulated gastric fluid (pH 1.2) was used as the dissolution medium.

    • Main Results:

    • All fourteen nifedipine capsule products met the acceptance criterion of > 80% drug release within 20 minutes.
    • No significant differences in dissolution performance were observed between the different suppliers or dosage strengths.
    • The dissolution rates were consistent and indicative of adequate drug release.

    Conclusions:

    • The tested nifedipine capsules from eight suppliers exhibit satisfactory in vitro dissolution profiles.
    • These findings suggest comparable drug release characteristics across multiple generic nifedipine products.
    • The study supports the quality and consistency of available nifedipine capsule formulations.