CN Patent

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

Patent Metadata

Patent number
CN115364065B
Jurisdiction
CN
Classification
Expires
2024-03-15
Drug substance claim
No
Drug product claim
No
Assignee
Ningbo High Tech Zone Menova Medical Innovation Research Institute Co ltd
Source
FDA Orange Book + USPTO grounding via Google Patents

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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