FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF CYCLODEXTRIN INCLUSION COMPLEXED WATER INSOLUBLE DRUG: GLIMIPIRIDE

Glimepiride (GMP) is a Third Generation Sulphonylureas used for treatment of type 2 diabetes. Poor water solubility is the main constraint for its oral bioavailability. The rationale of this study was to enhance the solubility and dissolution of the drug by preparing its complex with β-cyclodextrin and Hydroxypropyl Betacyclodextrin-β-cyclodextrin. In the present study attempt has been made to prepare, formulate and characterize inclusion complexes of Glimepiride with β-cyclodextrin and Hydroxypropyl Betacyclodextrin-β-cyclodextrin. The inclusion complexes were prepared by three different methods viz. Physical, Kneading and Co-precipitation method. The inclusion complex containing Glimepiride: β-cyclodextrin and Hydroxypropyl Betacyclodextrin-β-cyclodextrin was further formulated into Fast Dissolving Tablets (FDT) by Direct Compression Technique using Super-disintegrants like Crosscarmelose Sodium, Crospovidone and Sodium Starch Glycolate were used. The prepared Complexes were characterized using FT-IR and Differential Scanning Calorimetry and finally the prepared Fast Dissolving Tablets were Evaluated for various pharmaceutical characteristics viz. Hardness, % Friability, Weight Variation, Wetting Time, Drug Content and In-vitro Dissolution profiles. The results of stability studies revealed no change in physical appearance, hardness, drug content and in-vitro dissolution profiles, thus indicating that formulation was stable.