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Stability of digoxin tablets collected from U.S. hospitals
American Journal of Hospital Pharmacy
|December 1, 1981
Summary
Digoxin tablet stability was assessed in U.S. hospitals. Most samples met standards, with pre-1975 products showing dissolution issues, indicating overall market stability.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Pharmacopeial Standards
Background:
- Digoxin is a critical cardiac medication.
- Assessing the real-world stability of pharmaceutical products is essential for patient safety.
- Hospital storage conditions can impact drug efficacy.
Purpose of the Study:
- To evaluate the stability of digoxin tablets stored in U.S. hospital pharmacies.
- To determine if market conditions affect digoxin tablet quality.
- To compare drug product quality against established pharmacopeial standards.
Main Methods:
- Ninety-two digoxin tablet samples from three manufacturers were collected nationwide.
- Samples underwent laboratory analysis for content uniformity, strength, dissolution, identification, and fluorescing substances.
- Data collection involved contacting all U.S. hospital pharmacies in February 1980.
Main Results:
- Eighty-five out of ninety-two samples (92.4%) met current compendial standards.
- Seven samples failed dissolution specifications.
- The seven failing samples were all manufactured before July 1975, when United States Pharmacopeia (USP) dissolution requirements were revised.
Conclusions:
- Digoxin tablets generally exhibit adequate stability under typical hospital storage conditions.
- The study identified a specific batch of older digoxin products with dissolution issues predating revised USP standards.
- Overall, digoxin products were not adversely affected by marketplace variables.