Solubilized Felodipine Containing Sustained Release Preparations and it's Manufacturing Process

摘要

PURPOSE: A method for producing the titled formulation by solubilizing felodipine as a drug sparingly soluble in water in methylene chloride and ethanol and then spray drying is provided. Whereby, the formulation permits sustained release of a drug for a specified time to increase a therapeutic effect. CONSTITUTION: An effective amount of felodipine is solubilized with 0.5 to 20% by weight of polyvinylpyrrolidone as a water soluble polymer compound in a mixed solvent of methylene chloride and ethanol and then spray dried to produce solid dispersants. Thereafter, the dispersants are mixed with a sustained release base comprising 40 to 70% by weight of lactose, 5 to 40% by weight of Eudragit, 10 to 30% by weight of dicalcium phosphate dihydrate, 0.1 to 3% by weight of a lubricating agent and 0.1 to 3% by weight of magnesium stearate.