FORMULATION AND EVALUATION OF MITIGLINIDE GASTRO RETENTIVE DRUG DELIVERY SYSTEM
Journal: International journal of Pharmaceuticals and Health care research (Vol.02, No. 1)Publication Date: 2014-03-30
Authors : Kranthi Kumar P; Padmabhushanam P;
Page : 39-47
Keywords : Mitiglinide; Gastro retentive drug delivery system; In vivo studies; HPMC; Ethyl cellulose.;
Abstract
The objective of the present work is to design and evaluate gastroretentive drug delivery systems of mitiglinide to improve the type II diabetic mellitus therapy. In this work gastro retentive drug delivery systems of are prepared by using 24 factorial design employing hydrophilic polymers such as hydroxy propyl methyl cellulose K4M (HPMC K4M), hydroxy ethyl cellulose (HEC), hydrophobic fatty base, cetyl alcohol and effervescent material sodium bi carbonate (NaHCO3). The effects of all independent variables (HPMC K4M, HEC, Cetyl alcohol and NaHCO3) on drug release were determined. The sixteen formulations of optimization phase were categorized into five groups for ease of analysis as Group I, Group II, Group III, Group IV and Group IV by changing all variable at different levels. Parameters of evaluation are such as angle of repose, density, compressibility index, hausner’s ratio and primary evaluation parameters of such as thickness, hardness, friability, weight variation and swelling index. The angle of repose of F1 and F4 were highest and lowest for 28.38º and 24.02º respectively. The bulk density id highest for F9 and lowest for F11, while the Carr’s index is highest for F4 and lowest for F15, indicating that low value has the highest compressibility. Highest content was loss on friability test for F9.Hardness is highest for F10 and lowest for F11. Swelling index is more observed for F16 as a best formulation and these differences were insignificant and the best retards formulation was optimized by factorial plots and it has the swelling ration of 22.81 for F16 formulation. The floating abilities of single tablets were determined in 400mL of 0.1N Hcl. The drug release studies were carried out using dissolution media 0.1N Hcl buffer pH 1.2 at 235nm. The results clearly indicate that the content as well as the release of mitiglinide from the tablets is strongly affected by the variables selected for the study. The main effects of A, B, C, and D represent the average result of changing one variable at a time from its low level to its high level. The interaction terms (AB, AC, AD, BC, BD, CD, ABC, ABD, ACD, BCD, and ABCD) show how the dependent variables change when two, three and four independent variables are simultaneously changed.
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