METHODS OF PRODUCING PARATHYROID HORMONES-CONTAINING PREPARATIONS

• Main Authors: MATSUDA KENSAKU, YAMAWAKI NORIHIKO, TAGUCHI CHIHO, NISHIYAMA KANAME, MURAKAMI TAKUHIRO
• Format: Patent
• Language: English; Japanese
• Published: 20.04.2017
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

PROBLEM TO BE SOLVED: To provide methods of producing parathyroid hormones-containing preparations which are preparations having good quality immediately after production and which can maintain storage stability.SOLUTION: A method of producing a parathyroid hormones-containing preparation for freeze-drying comprises the steps of: preparing a solution containing parathyroid hormones; and cooling the solution under preparation and/or the obtained solution before a freeze-drying step. In the cooling step, preferably the solution is cooled to 15°C or less in a container which is filled with nitrogen and which has a wetted part made of polyethylene or polypropylene. Preferably, the freeze-dried preparation is contained in a container, a free-oxygen absorber is arranged outside the container, and further packaging with a resin bag having an oxygen permeability of 1 mL/m*day*atom or less and/or a water vapor permeation rate of 1 g/m*day or less is performed.SELECTED DRAWING: None 【課題】製造直後の品質が良好な製剤であり、かつ、保存安定性を維持することができるパラサイロイドホルモン類含有製剤の製造方法の提供。【解決手段】パラサイロイドホルモン類を含有する溶液を調製する工程、調製途中の溶液及び／又は得られた溶液を凍結乾燥工程の前に冷却する工程を含む凍結乾燥用パラサイロイドホルモン類含有製剤の製造方法。前記冷却工程において、窒素充填容器で接液部がポリエチレン又はポリプロピレンからなる容器で１５℃以下に冷却することが好ましい製造方法。凍結乾燥した制剤は容器に収容し、容器の外側に脱酸素剤を配置し、更に酸素透過性が１ｍＬ／ｍ２・日・ａｔｍ以下及び／又は水蒸気透過速度が１ｇ／ｍ２・日以下の樹脂製の袋で包装することが好ましい製造方法。【選択図】なし