{"title":"采用β - cd淀粉1500和溶液加成剂制备缬沙坦片剂","authors":"Chowdary K. P. R.","doi":"10.20959/WJPPS20179-10116","DOIUrl":null,"url":null,"abstract":"The objective of the present study is optimization of Valsartan tablet formulation employing βCD, Starch 1500, and Soluplus by 2 3 factorial design to achieve NLT 85% dissolution in 10 min. Eight Valsartan tablet formulations were prepared using selected combinations of the three factors as per 2 3 factorial design. Valsartan tablets were prepared by direct compression method and were evaluated. The individual and combined effects of the three factors βCD, Starch 1500 and Soluplus are highly significant (P < 0.01) in influencing the dissolution rate of Valsartan tablets. Valsartan tablet formulations Fb,Fab, Fbc and Fabc disintegrated rapidly and gave very rapid dissolution of Valsartan, 92.4%, 99.4%, 96.2% and 99.2% in 10 min respectively. The increasing order of dissolution rate (K1) observed with various formulations was F1< Fc< Fa< Fac< Fb< Fbc< Fab <Fabc. The polynomial equation describing the relationship between the response, percent drug dissolved in 10min (Y) and the levels of βCD (X1), Starch 1500 (X2) and Soluplus (X3) based on the observed results was found to be Y = 68.625 + 4.375(X1) + 27.375(X2) 2.375(X1 X2)+ 3.375(X3) + 0.125(X1 X3) 1.875(X2 X3) 0.625(X1 X2 X3) Based on the above equation, the formulation of optimized Valsartan tablets with NLT 85% dissolution in 10 min require βCD at 1:3.5 ratio of drug: βCD, Starch 1500 at 24.37% of drug and βCD content, and Soluplus at 1% of drug and βCD content. The optimized Valsartan tablet formulation gave 85.75% dissolution in 10min fulfilling the target dissolution requirement. Hence formulation of Valsartan tablets with NLT 85% dissolution in 10 min could be optimized by 2 3 factorial design. WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES SJIF Impact Factor 6.647 Volume 6, Issue 9, 1674-1683 Research Article ISSN 2278 – 4357 *Corresponding Author Prof. Chowdary K. P. R. Chairman, BOS in","PeriodicalId":23975,"journal":{"name":"World journal of Pharmacy and pharmaceutical sciences","volume":"51 1","pages":"1674-1683"},"PeriodicalIF":0.0000,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"FORMULATION DEVELOPMENT AND OPTIMIZATION OF VALSARTAN TABLETS EMPLOYING βCD STARCH 1500 AND SOLUPLUS\",\"authors\":\"Chowdary K. P. R.\",\"doi\":\"10.20959/WJPPS20179-10116\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The objective of the present study is optimization of Valsartan tablet formulation employing βCD, Starch 1500, and Soluplus by 2 3 factorial design to achieve NLT 85% dissolution in 10 min. Eight Valsartan tablet formulations were prepared using selected combinations of the three factors as per 2 3 factorial design. Valsartan tablets were prepared by direct compression method and were evaluated. The individual and combined effects of the three factors βCD, Starch 1500 and Soluplus are highly significant (P < 0.01) in influencing the dissolution rate of Valsartan tablets. Valsartan tablet formulations Fb,Fab, Fbc and Fabc disintegrated rapidly and gave very rapid dissolution of Valsartan, 92.4%, 99.4%, 96.2% and 99.2% in 10 min respectively. The increasing order of dissolution rate (K1) observed with various formulations was F1< Fc< Fa< Fac< Fb< Fbc< Fab <Fabc. The polynomial equation describing the relationship between the response, percent drug dissolved in 10min (Y) and the levels of βCD (X1), Starch 1500 (X2) and Soluplus (X3) based on the observed results was found to be Y = 68.625 + 4.375(X1) + 27.375(X2) 2.375(X1 X2)+ 3.375(X3) + 0.125(X1 X3) 1.875(X2 X3) 0.625(X1 X2 X3) Based on the above equation, the formulation of optimized Valsartan tablets with NLT 85% dissolution in 10 min require βCD at 1:3.5 ratio of drug: βCD, Starch 1500 at 24.37% of drug and βCD content, and Soluplus at 1% of drug and βCD content. The optimized Valsartan tablet formulation gave 85.75% dissolution in 10min fulfilling the target dissolution requirement. Hence formulation of Valsartan tablets with NLT 85% dissolution in 10 min could be optimized by 2 3 factorial design. WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES SJIF Impact Factor 6.647 Volume 6, Issue 9, 1674-1683 Research Article ISSN 2278 – 4357 *Corresponding Author Prof. Chowdary K. P. R. Chairman, BOS in\",\"PeriodicalId\":23975,\"journal\":{\"name\":\"World journal of Pharmacy and pharmaceutical sciences\",\"volume\":\"51 1\",\"pages\":\"1674-1683\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"World journal of Pharmacy and pharmaceutical sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.20959/WJPPS20179-10116\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"World journal of Pharmacy and pharmaceutical sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20959/WJPPS20179-10116","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
FORMULATION DEVELOPMENT AND OPTIMIZATION OF VALSARTAN TABLETS EMPLOYING βCD STARCH 1500 AND SOLUPLUS
The objective of the present study is optimization of Valsartan tablet formulation employing βCD, Starch 1500, and Soluplus by 2 3 factorial design to achieve NLT 85% dissolution in 10 min. Eight Valsartan tablet formulations were prepared using selected combinations of the three factors as per 2 3 factorial design. Valsartan tablets were prepared by direct compression method and were evaluated. The individual and combined effects of the three factors βCD, Starch 1500 and Soluplus are highly significant (P < 0.01) in influencing the dissolution rate of Valsartan tablets. Valsartan tablet formulations Fb,Fab, Fbc and Fabc disintegrated rapidly and gave very rapid dissolution of Valsartan, 92.4%, 99.4%, 96.2% and 99.2% in 10 min respectively. The increasing order of dissolution rate (K1) observed with various formulations was F1< Fc< Fa< Fac< Fb< Fbc< Fab
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