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Related Experiment Videos

Generic tolbutamide tablet dissolution: intralot and interlot variation.

J W Ayres, H P Huang, K Albert

    Journal of Pharmaceutical Sciences
    |November 1, 1984
    PubMed
    Summary
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    Manufacturing quality control for tolbutamide tablets varies significantly between brands. Dissolution testing reveals substantial differences in drug release, with some generic products showing poor performance, especially after humidity exposure.

    Area of Science:

    • Pharmaceutical Sciences
    • Drug Delivery Systems
    • Quality Control

    Background:

    • Tolbutamide is an oral hypoglycemic agent used to manage type 2 diabetes.
    • Ensuring consistent drug release from generic formulations is crucial for therapeutic efficacy.
    • Variability in manufacturing can impact drug dissolution and bioavailability.

    Purpose of the Study:

    • To characterize dissolution profiles of tolbutamide tablets from multiple manufacturers.
    • To assess the impact of manufacturing variability and environmental factors on drug release.
    • To compare USP paddle-stirrer and rotating-basket dissolution methods.

    Main Methods:

    • Dissolution testing of 62 tolbutamide tablet lots using the USP paddle-stirrer apparatus.
    • Correlation analysis between paddle-stirrer and USP rotating-basket dissolution results.

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  • Evaluation of tablet stability under varying humidity conditions (60%, 75%, 98% RH).
  • Assessment of dissolution after pretreatment with simulated gastric fluid.

    • Main Results:

    • Paddle-stirrer dissolution correlated well with rotating-basket results (r² = 0.7444).
    • Significant interlot and intralot variability in dissolution was observed, highly dependent on the manufacturer.
    • One lot failed to meet dissolution specifications across both methods.
    • Humidity aging significantly depressed dissolution in some generic tablets, while the innovator's product remained stable.
    • Simulated gastric fluid pretreatment improved dissolution for one poorly performing lot.

    Conclusions:

    • Manufacturing quality control for tolbutamide tablets is inconsistent across different brands.
    • Generic tolbutamide tablet performance, particularly under humid conditions, can be unreliable.
    • Dissolution testing is a critical tool for identifying manufacturing inconsistencies and ensuring product quality.