Pharmaceutical composition or a solid pharmaceutical composition for treating hyperproliferative disorder, comprises amorphous solid dispersion of enzalutamide as active agent in a mixture of hydroxypropyl methylcellulose phthalate and cellulose acetate phthalate as excipients
	STAVER R; HARTWIG K; RACHAKONDA V R; NADELLA N P; JOSHI A R; MANKALA S K; TUNGUTURI M M
	2023-12-06
专利权人	TIEFENBACHER GMBH & CO KG ALFRED E (TIEF-Non-standard) ; TIEFENBACHER GMBH & CO KG ALFRED E (TIEF-Non-standard)
申请日期	2023-12-06
专利号	IN202311083018-A; EP4520322-A1
成果简介	NOVELTY - Pharmaceutical composition comprises: an amorphous solid dispersion of enzalutamide as active agent in a mixture of hydroxypropyl methylcellulose phthalate and cellulose acetate phthalate as excipients. USE - Pharmaceutical composition or a solid pharmaceutical composition for treating hyperproliferative disorder, preferably treatment of adult men with non-metastatic castration-resistant prostate cancer (CRPC), adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated, or adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy (all claimed). No biological data given. ADVANTAGE - The pharmaceutical composition, preferably tablet or film-coated tablet, have less disintegration time of up to 10 minutes, alternatively of up to 5 minutes, thus active agent be dissolved in the aqueous environment and, thus may resorbed. DETAILED DESCRIPTION - An INDEPENDENT CLAIM is included for a method for preparing a solid pharmaceutical composition prepared according to hot melt extrusion containing enzalutamide as active ingredient and excipients in an amorphous solid dispersion comprising: (a) mixing a pharmaceutical amount of enzalutamide as active ingredient together with excipients comprising or consisting of hydroxypropyl methylcellulose phthalate and cellulose acetate phthalate; (b) heating the mixture to form a melt and extruding the formed melt followed by subsequent cooling the extrudate to form an amorphous solid dispersion comprising enzalutamide, hydroxypropyl methylcellulose phthalate and cellulose acetate phthalate; (c) optionally further processing the amorphous solid dispersion to form a solid pharmaceutical formulation selected from a powder, granules, pellets, and beads; (d) optionally further processing the solid pharmaceutical formulation with one or more further excipients selected from diluent agent, flow enhancer agent, disintegrant agent, binder agent, solubilizer agent, and lubricant agent to form a solid pharmaceutical unit dosage formulation selected from tablets, film-coated tablets, capsules, caplets, and multiple unit pellet systems.
IPC 分类号	A61K-031/17 ; A61K-031/415 ; A61K-031/4166 ; A61K-047/32 ; A61K-047/38 ; A61K-009/10 ; A61K-009/14 ; A61K-009/00 ; A61K-009/16
国家	印度
专业领域	医药卫生
语种	英语
成果类型	专利
文献类型	科技成果
条目标识符	http://119.78.100.226:8889/handle/3KE4DYBR/19037
专题	中国科学院新疆生态与地理研究所
作者单位	1.TIEFENBACHER GMBH & CO KG ALFRED E (TIEF-Non-standard) 2.TIEFENBACHER GMBH & CO KG ALFRED E (TIEF-Non-standard)
推荐引用方式 GB/T 7714	STAVER R,HARTWIG K,RACHAKONDA V R,et al. Pharmaceutical composition or a solid pharmaceutical composition for treating hyperproliferative disorder, comprises amorphous solid dispersion of enzalutamide as active agent in a mixture of hydroxypropyl methylcellulose phthalate and cellulose acetate phthalate as excipients. IN202311083018-A; EP4520322-A1[P]. 2023.

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