{"title":"格列吡嗪-盐酸二甲双胍聚合物双层基质片的研制及评价","authors":"Lakshmana Prabu S","doi":"10.23880/beba-16000139","DOIUrl":null,"url":null,"abstract":"The objective of the present study was to develop Bilayer tablets of Glipizide and metformin hydrochloride from polymeric matrices of HPMC K4M and Eudragit L-100. Drugs Glipizide and metformin hydrochloride are frontline anti-diabetic drugs prescribed in combination. Tablets were prepared by wet granulation method using different ratios of HPMC K4M and Eudragit L-100 and evaluated for its physicochemical properties, in vitro release profile and stability studies. The prepared granules physiochemical property results were within the limits and the formulated tablets hardness, friability and content uniformity was found to be between 5.1±0.1 and 5.9±0.3; 0.21 ±0.02 and 0.49±0.02%; 98.99 ±1.06 and 100.45±0.52 %w/w respectively. The invitro release was found to be observed for 12 hours in phosphate buffer pH 6.8 and compared with market formulation. The dissolution release of formulation was comparable with market formulation and the difference factor and similarity factor f1 and f2 were found to be 3.75 and 79.46 for metformin hydrochloride; 8.74 and 65.78 for glipizide respectively. Stability studies were carried out as per ICH guidelines and tested for its physicochemical properties and in vitro release studies. The stability study result reveals that the prepared formulation was stable.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Formulation and Evaluation of Polymeric Bilayer Matrix Tablet Containing Glipizide and Metformin Hydrochloride\",\"authors\":\"Lakshmana Prabu S\",\"doi\":\"10.23880/beba-16000139\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The objective of the present study was to develop Bilayer tablets of Glipizide and metformin hydrochloride from polymeric matrices of HPMC K4M and Eudragit L-100. Drugs Glipizide and metformin hydrochloride are frontline anti-diabetic drugs prescribed in combination. Tablets were prepared by wet granulation method using different ratios of HPMC K4M and Eudragit L-100 and evaluated for its physicochemical properties, in vitro release profile and stability studies. The prepared granules physiochemical property results were within the limits and the formulated tablets hardness, friability and content uniformity was found to be between 5.1±0.1 and 5.9±0.3; 0.21 ±0.02 and 0.49±0.02%; 98.99 ±1.06 and 100.45±0.52 %w/w respectively. The invitro release was found to be observed for 12 hours in phosphate buffer pH 6.8 and compared with market formulation. The dissolution release of formulation was comparable with market formulation and the difference factor and similarity factor f1 and f2 were found to be 3.75 and 79.46 for metformin hydrochloride; 8.74 and 65.78 for glipizide respectively. Stability studies were carried out as per ICH guidelines and tested for its physicochemical properties and in vitro release studies. The stability study result reveals that the prepared formulation was stable.\",\"PeriodicalId\":8995,\"journal\":{\"name\":\"Bioequivalence & Bioavailability International Journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bioequivalence & Bioavailability International Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.23880/beba-16000139\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bioequivalence & Bioavailability International Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.23880/beba-16000139","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Formulation and Evaluation of Polymeric Bilayer Matrix Tablet Containing Glipizide and Metformin Hydrochloride
The objective of the present study was to develop Bilayer tablets of Glipizide and metformin hydrochloride from polymeric matrices of HPMC K4M and Eudragit L-100. Drugs Glipizide and metformin hydrochloride are frontline anti-diabetic drugs prescribed in combination. Tablets were prepared by wet granulation method using different ratios of HPMC K4M and Eudragit L-100 and evaluated for its physicochemical properties, in vitro release profile and stability studies. The prepared granules physiochemical property results were within the limits and the formulated tablets hardness, friability and content uniformity was found to be between 5.1±0.1 and 5.9±0.3; 0.21 ±0.02 and 0.49±0.02%; 98.99 ±1.06 and 100.45±0.52 %w/w respectively. The invitro release was found to be observed for 12 hours in phosphate buffer pH 6.8 and compared with market formulation. The dissolution release of formulation was comparable with market formulation and the difference factor and similarity factor f1 and f2 were found to be 3.75 and 79.46 for metformin hydrochloride; 8.74 and 65.78 for glipizide respectively. Stability studies were carried out as per ICH guidelines and tested for its physicochemical properties and in vitro release studies. The stability study result reveals that the prepared formulation was stable.