SPRAY DRYING METHOD FOR MANUFACTURING MEDICINE POWDER COMPOSITION BEING COMPRESSABLE DIRECTLY TO TABLET

摘要

PURPOSE: To provide both a method for producing naproxen and a naproxen sodium powdery composition suitable for direct compression into a tablet and a method for producing the tablet of the naproxen and naproxen sodium using the powdery composition. CONSTITUTION: This method for producing a pharmaceutical powdery composition comprises carrying out the spray-drying of an aqueous slurry/solution of naproxen and/or naproxen sodium (the slurry may directly be obtained without drying in a synthetic process for the agent) alone or mixing the aqueous slurry/ solution with an aqueous mixture of an excipient substance and performing the spray-drying of the mixture in a controlled manner. The resultant powder is coated with an excipient uniformly distributed therein and has a uniform particle size. The powdery composition is prepared according to the method for production and a tablet formula is obtained by adding a lubricant to the powdery medicine. The powdery composition can readily and directly be compressed to easily form a tablet. The table thus formed by using the spray-dried powdery composition can readily be eluted and is stable under normal preserving conditions and severe conditions of temperature and relative humidity.