POLYMORPHISM AND SOLID STATE TRANSITION OF ANTIHYPERLIPIDEMIC DRUG SIMVASTATIN: PREPRATION, CHARACTERIZATION AND OPTIMIZATION BY USING CCD & RSM
AbstractRecently it has been growing interest in investing solid state transition forms prepared by different technique. The majority of drugs are administered in solids form. Among all newly discovered chemical entities about 40% drugs are lipophillic and fail to reach market due to their poor aqueous solubility. Problem of solubility is a major challenge for formulation scientist, which can be resolved by different technological approaches. Simvastatin belong to class of antihyperlipidemic drugs having very low solubility and falls in category II Class of BCS. Polymorphism and solid state transitions change the solid-state property which is significantly influence the performance of the final product such as solubility, Melting Point, Dissolution Rate and flow property. Optimization process like RCM and CCD design was used to study the effect of variables such as solubility and melting point for quality determination of formulation. Solvent evaporation method is used in this study to prepare new transition form. This technique has more advantages and it is preferred method over others such as spray drying, sonication and homogenization. Through the characterized analysis (SEM, XRD, ATR, DSC, Solublity and melting point) of optimised form, given reliably confirmation data that the new solid state transition forms is amorphous form. It is more soluble than crystalline form.