Preparation of Valsartan Tablets and evaluation of quality consistency / 药物评价研究

Objective To develop a formulation of generic Valsartan Tablets and evaluate the quality consistency in vitro.Methods Diovan(R)~ HCT (80 mg) was used as the reference drug.In order to determine the best formulation and the best preparation processing,the single factor experiments were applied to determining the best formulation and the best preparation processing.And dissolution test was used as the evaluation index in the single factor experiments.Meanwhile the dissolubility of generic Valsartan Tablets and original preparation was investigated in four different media to evaluate the similarity of dissolution by calculating similar factor (f2).Results The dissolution was above 85％ of three batches of generic Valsartan Tablets in the phosphate buffer (pH 6.8).The similar factors were all more than 50 in the water,hydrochloric acid solution (pH 1.2),and acetate buffer solution (pH 4.5).Conclusion The f2 similarity factor results indicate a similarity in the reference drug and generic Valsartan Tablets which were developed by single factor experiments,which means the quality of genetic Valsartan Tablets is qualified.

Preparation of irbesartan tablets and consistency study of their dissolubility / 药物评价研究

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.