SIROLIMUS-CONTAINING GRANULAR PREPARATION, AND METHOD FOR PRODUCING THE SAME

• Main Authors: YASUZAWA TORU, NOMURA TATSUO
• Format: Patent
• Language: English; Japanese
• Published: 10.06.2021
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

To provide a sirolimus-containing powder granular preparation that ensures bioabsorptivity and has improved stability.SOLUTION: A sirolimus-containing granular preparation contains sirolimus and tocopherol and contains no hydroxypropyl cellulose. A method for producing a sirolimus-containing granular preparation includes the step (1) for mixing a solution containing sirolimus and tocopherol with a core particle to be a core of a granular preparation in the absence of hydroxypropyl cellulose, and the step (2) for drying the mixture obtained in the step (1).SELECTED DRAWING: Figure 1 【課題】生体吸収性が担保され、かつ安定性が向上した、シロリムス含有粉末顆粒製剤を提供する。【解決手段】シロリムスとトコフェロールとを含有し、ヒドロキシプロピルセルロースを含まない、シロリムス含有顆粒製剤、並びに、（１）シロリムスとトコフェロールとを含有した溶液と、顆粒製剤の核となるコア粒子とをヒドロキシプロピルセルロースの不存在下で混合する工程、及び（２）工程（１）で得られた混合物を乾燥させる工程を含むことを特徴とする、シロリムス含有顆粒製剤の製造方法。【選択図】図１