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Solid-State Stability Testing of Drugs by Isothermal Calorimetry

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Abstract

A new technique has been developed to calculate rapidly the solid-state room-temperature degradation rate of drugs and drug candidates. The technique utilizes measurements of the initial rate of heat output at several elevated temperatures by isothermal calorimetry and the degradation rate of the compound determined at a single elevated temperature by chromatography. The activation energies and degradation rates at 25°C calculated by conventional methods and by isothermal calorimetry are compared and discussed. The compounds studied were phenytoin, triamterene, digoxin, tetracycline, theophylline, diltiazem, and several proprietary ICI compounds.

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Authors and Affiliations

  1. A Business Unit of ICI Americas, ICI Pharmaceuticals Group, Wilmington, Delaware, 19897

    Michael J. Koenigbauer, Stephen H. Brooks, Gregory Rullo & Richard A. Couch

  2. Pfizer Pharmaceuticals Inc., P.O. Box 628 Barceloneta, Puerto Rico, 00617

    Stephen H. Brooks

Authors
  1. Michael J. Koenigbauer
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  2. Stephen H. Brooks
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  3. Gregory Rullo
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  4. Richard A. Couch
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Koenigbauer, M.J., Brooks, S.H., Rullo, G. et al. Solid-State Stability Testing of Drugs by Isothermal Calorimetry. Pharm Res 9, 939–944 (1992). https://doi.org/10.1023/A:1015865319250

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  • DOI: https://doi.org/10.1023/A:1015865319250

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