Stability of nitroglycerin tablets submitted by U.S. hospitals

Area of Science:

• Pharmaceutical Sciences
• Drug Stability
• Quality Control

Background:

• Nitroglycerin tablets are crucial for treating angina.
• Assessing drug stability under real-world conditions is vital for patient safety.
• Previous studies highlighted potential variability in nitroglycerin tablet performance.

Purpose of the Study:

• To evaluate the stability and quality of nitroglycerin tablets stored in U.S. hospitals.
• To assess the performance of the United States Pharmacopeia (USP) disintegration test for nitroglycerin.
• To determine if storage conditions impact nitroglycerin tablet efficacy.

Main Methods:

• A voluntary survey collected data on nitroglycerin tablets from hospital pharmacies nationwide.
• 167 samples from three manufacturers were analyzed for content uniformity, strength, identification, and disintegration.
• Dissolution testing was performed on select samples with unusual disintegration characteristics.

Main Results:

• All analyzed nitroglycerin tablets met USP requirements for content uniformity, strength, and disintegration.
• Six samples exhibited slow dissolution despite passing standard disintegration tests.
• The USP disintegration test did not reliably differentiate between rapidly and slowly dissolving tablets.

Conclusions:

• Nitroglycerin tablets demonstrate stability when stored under actual clinical conditions.
• The current USP disintegration test may be insufficient for predicting nitroglycerin tablet dissolution performance.
• Further investigation into dissolution testing methods for nitroglycerin is warranted.