Collaborative study of the USP dissolution test for prednisone tablets with Apparatus 2

Area of Science:

• Pharmaceutical Sciences
• Drug Formulation and Delivery

Background:

• Prednisone tablets are widely used for various medical conditions.
• Ensuring consistent drug release is crucial for therapeutic efficacy.
• Standardized dissolution testing is essential for quality control.

Purpose of the Study:

• To assess the performance of USP Apparatus 2 for prednisone tablet disintegration.
• To evaluate the reproducibility and repeatability of the dissolution method across multiple laboratories.

Main Methods:

• Five lots of prednisone tablets with rapid disintegration (<5 min) were tested.
• Eleven laboratories participated in a collaborative study.
• United States Pharmacopeia (USP) Apparatus 2 was used under controlled conditions.

Main Results:

• One lot exhibited complete dissolution within the specified timeframe.
• For the remaining four lots, the reproducibility was 2.6% of label claim.
• The repeatability of the method was 1.6% of label claim across laboratories.

Conclusions:

• USP Apparatus 2 is a reliable method for evaluating prednisone tablet dissolution.
• The dissolution testing method shows acceptable variability for quality control.
• The study confirms the suitability of the method for ensuring prednisone tablet quality.