Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan

Muhammad Mohsin Ansari, Muhammad Zain Amin, Usman Ashraf, Muhammad Noman Ehsan, Muhammad Farhan, Hina Aasil,Hina Ahsan

DISSOLUTION TECHNOLOGIES(2023)

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摘要
The purpose of this study was to perform a comparative dissolution study of various brands of valsartan tablets marketed in Pakistan. This drug belongs to BCS class II, which has high permeability and low solubility. Four different brands of valsartan tablets (80 mg) were collected from the local market of Rawalpindi and Islamabad, labeled as A, B, C, and D. All brands were evaluated for weight variation, hardness, friability, disintegration, and dissolution. Brand A (multinational brand) was selected as a reference for having a good dissolution profile. A model independent approach, f1 (difference factor),f2 (similarity factor), and dissolution efficiency were used to compare the brands. Results of the dissolution study showed that f1 and f2 for all brands were within the specified limits of 0-15 for f1 and 50-100 for f2. Mean dissolution efficiency and 95% confidence intervals were within the acceptable range of +/- 10% for all brands. All other quality control test results were within the acceptable ranges, except hardness of brand C. Dissolution profiles of brands B, C, and D were comparable with brand A (and have much lower prices). Therefore, brands B, C, and D can be prescribed in place of brand A, which will be more cost-effective for the patients.
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关键词
Valsartan, dissolution, f1 and f2 factor analysis, dissolution efficiency, bioavailability
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