Quality and Behavior of Glimepiride Generics Versus Amaryl Under Stressed Conditions

Abstract

Background:

The use of generic versions of drugs, such as those for glimepiride [Amaryl^®, Amarel^®, Solosa^® (sanofi-aventis, Paris, France)], a third-generation sulfonylurea, can reduce healthcare costs. However, the quality and performance of these generics should be carefully evaluated.

Methods:

We compared the quality and behavior of 23 marketed generic forms with Amaryl (all 2 mg) under stressed conditions. Deblistered samples were stored at 60°C for 21 days in order to mimic temperature-stressed conditions. Samples were analyzed at Days 0, 7, and 21 for content of active compound, levels of impurities, levels of residual solvent (Day 0 only), and dissolution profile, and results were compared against Amaryl specifications.

Results:

Levels of the degradation product glimepiride sulfonamide were ≤1% in all products at Day 0 but increased to above Amaryl specifications (≤2.5%) in two generics at Day 7 and in four generics at Day 21. Total levels of other impurities and levels of residual solvents were above Amaryl specifications (≤1.0% and >1,400 ppm, respectively) in two generics at Day 0. At Day 0, the dissolution of 12 generics (52%) failed to meet Amaryl specifications (≥85% dissolved in 15 min); this trend was confirmed at Day 21. Overall, 74% (17 of 23) of the generics were not of equivalent quality or performance compared with Amaryl.

Conclusions:

This study indicates that a relevant percentage of glimepiride generics may offer reduced quality and performance when compared with the original drug.