Design development and characterization of modified release dosage forms containing anti diabetic drug combination

Abstract

quotBackground: Multiple drug therapies are necessary for disease like diabetes and they must be administered in an orderly manner. The drug regimen often leads to non-compliance. Therapies need more than one drug to be administered working through various mechanisms of action. Thus, a variety of customized dosage forms have been created especially for disorders related to a sedentary lifestyle. newlineAim: Aim of the present study was to combine frequently co-administered drugs in diabetes in form of bilayer tablet (Pioglitazone HCl and Vildagliptin) and sustain release tablet (Nateglinide and Vildagliptin). Bilayered tablets where, in one drug is sustained release (SR) and one immediate release (IR) and in second dosage form Sustain release tablets working by reducing dose related side effects, reducing dosing frequency, cost of manufacturing and improving patient compliance. newlineMaterials and Methods: In Bilayered tablets immediate layer was prepared in by different superdisintegrants like cross carmellose sodium, sodium starch glycolate and crospovidone and the sustain layer was prepared with polymers like HPMC K4 M, HPMC K100 M and Carbopol 934 as release retarding polymers by wet granulation method. While in second dosage form chitosan, xanthan gum, HPMC K15 and HPMC K100 M were used as sustained release polymers and prepared by wet granulation method. The blends of immediate and sustained release were subjected to pre compression parameters like angle of repose, bulk and tapped density, Carr s index and Hausner s ratios. The Bilayered tablets were evaluated for pre and post-compression characteristics like hardness, weight variation, thickness, friability test, drug content and in vitro dissolution study. Bilayer tablets were optimized using 32 factorial designs and sustain release tablets by central composite design by using design expert software. The optimized batch of both the formulation was subjected to stability studies as per ICH guidelines. newlineResults and Discussion: FTIR and studies showed no interaction between