Albendazole generics--a comparative in vitro study.

Abstract

PURPOSE: We sought to determine whether disintegration and dissolution behavior differs among various albendazole generic formulations obtained from third world countries and to compare them with the innovator's product. METHODS: Dissolution behavior of various albendazole formulations was studied with USP Apparatus 2 in SGFsp and in a modified SGFsp which contained 0.1% of the nonionic surfactant Triton X 100. Disintegration was tested according to the European Pharmacopoeia. RESULTS: Dissolution experiments in SGFsp showed a wide range in rate and extent of albendazole dissolution. The innovator product released 81 percent within two hours, a profile matched by only one other formulation. For other formulations 32 to 64% was released within two hours. Use of a modified SGFsp, containing 0.1% Triton X 100 to simulate the surface tension of gastric juice, resulted in less discrimination between products. The innovator product again showed the fastest and most complete dissolution, with ninety percent released within two hours. The generic formulations released between 67 and 82%, except for one formulation which achieved only 43% release. The results in SGFsp plus Triton X 100 may be more meaningful than in SGFsp since the surface tension of the medium is closer to the physiological value. All formulations passed the disintegration test according to the European Pharmacopoeia, with disintegration times ranging from 2.5 to 11 minutes. CONCLUSIONS: Generic albendazole products vary widely in their dissolution behavior. Differences among products were greater in SGFsp than in SGFsp plus Triton X 100. These differences were not reflected in the disintegration behavior of the products.