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Stability of stabilized nitroglycerin tablets in typical distribution and administration systems
American Journal of Hospital Pharmacy
|August 1, 1975
Summary
Newer stabilized nitroglycerin tablets maintain potency under normal use and some stress conditions. One brand demonstrated superior stability, suggesting less restrictive packaging may be feasible for patient care.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Formulation Development
Background:
- Current packaging regulations for nitroglycerin tablets are stringent.
- Advancements in tablet stabilization may allow for less restrictive packaging.
Purpose of the Study:
- To evaluate the necessity of extreme packaging restrictions for stabilized nitroglycerin tablets.
- To assess the stability of different nitroglycerin tablet formulations under various conditions.
Main Methods:
- Baseline testing of weight variation, content uniformity, potency, and friability.
- Stability testing including simulated patient use, open plate exposure, strip packaging, medication cup exposure, and repackaging.
- Evaluation of potency retention across different packaging scenarios.
Main Results:
- All tested nitroglycerin tablet brands retained potency during normal use in original containers.
- One specific brand exhibited superior stability under stress conditions, including open plate exposure.
- This superior brand maintained labeled potency in medication cups, various strip packaging, and common prescription containers.
Conclusions:
- A specific brand of stabilized nitroglycerin tablets may be suitable for less restrictive packaging in hospital settings.
- Handling this brand like other solid dosage forms could be possible without compromising patient safety.
- Any deviations from current packaging restrictions require approval from the Food and Drug Administration.