Pre-study of hot melt extrusion by developing a casting method
Poor aqueous solubility is one of the main problems encountered by pharmaceutical industries. Hot melt extrusion is a new technology in manufacturing drug products which can be used to enhance the aqueous solubility of active pharmaceutical ingredients without using any solvent. This research is executed as the prior study to obtain the ratio of active pharmaceutical ingredients and solubilizer in hot melt extrusion process. The purpose of this research is to improve the dissolution rate of fenofibrate with Soluplus® as solubilizer, obtain the optimum ratio and evaluate the economic perspective. This research used solid dispersion technique, which is well known for enhancing poor aqueous solubility API. The experiment was executed with 1:5, 1:9, and 1:13 proportion of fenofibrate and Soluplus®. Ratio 1:13 showed the best result which has the most transparent film and has the highest dissolution rate of 0.4 ppm/min. Even though the production cost using this method is much more expensive than conventional one, there is benefit which is dosage reduction of fenofibrate. Dosage reduction could lead to less toxicity and less side effect for patients who use this medicine as long term medication.
B01256 | (wh) | Available |
No other version available