CN115364065B — 富马酸伏诺拉生片
Assigned to Ningbo High Tech Zone Menova Medical Innovation Research Institute Co ltd · Expires 2024-03-15 · 2y expired
What this patent protects
本发明公开了富马酸伏诺拉生片,本方案中去除了常规有机酸组分,以酸性碱土金属盐给API提供微酸性环境,同时碱土金属盐还起到填充剂的作用,并针对性调整了辅料的量比,在上述配方下成型的片剂在稳定性上可得到保证,且在制备工艺上可直接通过粉末直压成型片剂,工艺流程简化,生产耗能及材料成本等降低。此外,经检测,片剂的可满足产品CQA的标准,包括含量、溶出度、含量均匀度、降解产物要求等。
USPTO Abstract
本发明公开了富马酸伏诺拉生片,本方案中去除了常规有机酸组分,以酸性碱土金属盐给API提供微酸性环境,同时碱土金属盐还起到填充剂的作用,并针对性调整了辅料的量比,在上述配方下成型的片剂在稳定性上可得到保证,且在制备工艺上可直接通过粉末直压成型片剂,工艺流程简化,生产耗能及材料成本等降低。此外,经检测,片剂的可满足产品CQA的标准,包括含量、溶出度、含量均匀度、降解产物要求等。
Drugs covered by this patent
Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.
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