THE PRESENT RESEARCH WORK WAS CARRIED OUT TO DEVELOP A BI-LAYER TABLET OF TOLBUTAMIDE HCL AS EXTENDED RELEASE LAYER AND ACARBOSE AS IMMEDIATE RELEASE LAYER FROM THEIR RESPECTIVE SOLID DISPERSIONS.

摘要

The present investigation studied a novel Bilayer tablet having Extended Release system of Tolbutamide with Eudragit RS 100 and RL 100 and Immediate Release system of Acarbose with PVP K30 and PEG 6000 in different ratios using solvent evaporation and cogrinding techniques. SDs was characterized by Fourier-transformed Infrared Spectroscopy (FT-IR), Differential Scanning Calorimetry (DSC), Powder X-Ray Diffractometry (XRD), Scanning Electron Microscopy (SEM) as well as by content uniformity, in-vitro dissolution studies and release kinetics. Selected SD system was subjected to Bilayer tablet preparation by direct compression. Compressed tablets were evaluated for drug content, weight variation, friability, hardness, thickness, and in-vitro dissolution studies. The progressive disappearance of IR, X-Ray and thermotropic drug signals in SDs and physical mixtures were related to increasing amount of polymers. SEM studies suggested the homogenous dispersion of drug in polymers. FT-IR studies confirmed the formation of hydrogen bonding between drug and polymer. All tablet formulations showed compliance with pharmacopoeial standards and were of acceptable quality with regard to hardness, friability and tensile strength. In-vitro dissolution studies were carried out in a USP apparatus II. The formulations gave an initial burst effect to provide the loading dose of the drug followed by extended release for 12 hrs. In-vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. Stability studies conducted for optimized formulation did not show any change in physical properties, drug content, and in-vitro drug release. The present study concluded that Bilayer tablets of Tolbutamide and Acarbose as an alternative to the conventional dosage form.