Formulation and Evaluation of Glimepiride Solid Dispersion Tablets for Their Solubility Enhancement

Abstract

Glimepiride (GMP) is poorly water soluble drug, so solubility is the main constraint for its oral bioavailability. The objective of the research project is to enhance of the solubility of Glimepiride by using solid dispersion technique. The polymers used were Poloxamer 188 and Poloxamer 407 and solid dispersions were prepared by kneading method. The solubility study was carried out to study the effect of polymers on solubility of Glimepiride. The prepared solid dispersions were characterized by In-vitro solubility Study, %Drug content; Fourier transforms spectroscopy (FTIR), In vitro drug dissolution to identify the physicochemical interaction between drug and excipients. The dissolution studies of solid dispersion were performed by using USP II apparatus. The solid dispersion prepared with Poloxamer 188 showed better drug release as compared to solid dispersion prepared with Poloxamer 407. The drug release profile of F5 batch with Poloxamer 188 was 98.20±0.19 in 60 min. and drug release profile of F11 batch with Poloxamer 407 was 97.39±0.18 in 60 min. in pH 7.4. The results of dissolution studies and stability study the kneading method prepared solid dispersion by using Poloxamer 188 (Batch F5) was selected for tablet formulation. Tablet formulations were prepared by direct compression technique and developed tablet formulations were evaluated for various pharmaceutical characteristics viz. hardness, % friability, weight variation, drug content, in-vitro dissolution profiles. Thus Results showed that the solid dispersion technique by using poloxamer successfully used for enhancing the solubility of Glimepiride.