Effect of Solvent and Crystallization Method on Physicochemical Properties of Aceclofenac and Fenofibrate

Aims: Aim of this study was to prepare Aceclofenac and Fenofibrate crystals by cooling crystallization and non-cooling crystallization methods using various solvents. Also to study the effect of crystallization conditions, method of crystallization and type of solvents on physicochemical properties of drug crystals. Study Design: By Crystallization method using various solvents. Place and Duration of Study: The study was performed in Department of Pharmaceutics, Ashokrao Mane College of Pharmacy, Peth-Vadagoan, Tal. Hatkanangale, Dist. Kolhapur, Maharashtra, India-416112 and the duration was two years. Methodology: Study was performed by cooling crystallization and non-cooling crystallization methods using various solvents like Ethanol, Methanol, Dioxane, Ethyl acetate, Tetrahydrofuran, Butanol, Dichloromethane, Cyclohexane, Hexane and 2- Propanol. Results: Aceclofenac and Fenofibrate crystals were successfully prepared by cooling crystallization and non-cooling crystallization methods using various solvents. Obtained crystals have shown different particle size and crystal habit with change in method and solvent along with enhanced solubility and dissolution rate. FTIR, DSC and XRD study has indicated no any chemical modification in the drug during process. Conclusion: Prepared crystals have improved particle size along with enhanced solubility and dissolution than pure drug has signified the commercial applicability of the method in manufacturing the solid dosage forms. Thus optimizing crystallization method in conjunction with appropriate solvent can produce crystals with expected properties for manufacturing ease in pharmaceutical industry.