Preparation of irbesartan tablets and consistency study of their dissolubility

VernacularTitle:厄贝沙坦片的制备工艺与溶出度一致性研究
Author: Jinqing LI ; Danzhao LUO ; Ning LI ; Chongkai GAO
Keywords: irbesartan; consistency; dissolution profile; similar factor (f2)
From: Drug Evaluation Research 2017;40(5):600-606
CountryChina
Language:Chinese
Abstract: Objective To prepare generic irbesartan tablets and to evaluate its consistency of dissolution tests.Methods Using the original drugs (irbesartan) as reference drug,the single factor experiments were applied to investigating the type and amount of adhesive,tablet hardness,water content of tablets,and coating weight.ZRS-8G Dissolution Tester was used to conduct the dissolution tests which were carried on four different dissolution media.Then the similar factor (f2) was adopted to evaluate the similarity of dissolution between the original drug and generic drug.Results As the stabilizer,3％ HPMC-E5 was more stable than 5％ PVP K30.It had no difference of dissolution between original and generic drugs when the amount of adhesive,tablets hardness and water content were within the range of investigation.And the coating weight was 2％ to 3％.Moreover,the f2 values of original drug and generic drug were all greater than 50 in different dissolution media.Conclusion Thef2 results indicate a similarity in the dissolution behavior of reference drug and generic irbesartan tablets prepared by the single factor experiments.And the preparation process of generic irbesartan tablets is stable.