Comparative dissolution performance of internationally available piroxicam products

Area of Science:

• Pharmaceutical Sciences
• Drug Dissolution Testing
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

Background:

• Piroxicam is a globally utilized NSAID available under numerous brand names.
• The United States Pharmacopeial Convention (USP) set dissolution standards for piroxicam in 1985.
• Ensuring consistent drug product quality is crucial for patient safety and therapeutic efficacy.

Purpose of the Study:

• To assess and contrast the dissolution profiles of various international piroxicam products.
• To evaluate compliance with the USP dissolution test for piroxicam capsules.

Main Methods:

• Utilized the official USP dissolution test method designed for piroxicam capsules.
• Tested 25 brands of piroxicam capsules and 5 brands of piroxicam tablets.
• Applied the capsule dissolution test to tablet formulations in the absence of a specific tablet test.

Main Results:

• A significant majority (72%) of evaluated piroxicam capsule brands failed to meet USP dissolution requirements.
• A high percentage (80%) of tested piroxicam tablet brands also failed to meet the USP capsule dissolution standards.
• Several products exhibited substantial deviations from the established dissolution criteria.

Conclusions:

• Widespread non-compliance with USP dissolution standards among international piroxicam products.
• Observed formulation disparities indicate potential variations in bioavailability across different piroxicam products.
• Healthcare providers should consider these dissolution performance differences when prescribing multisource piroxicam.