CN115671074B — 一种甲磺酸仑伐替尼制剂及其制备方法
Assigned to Zhengzhou Antu Industrial Group Co ltd · Expires 2024-06-04 · 2y expired
What this patent protects
本发明公开了一种甲磺酸仑伐替尼制剂及其制备方法，属于药物制剂技术领域。本发明所述的甲磺酸仑伐替尼制剂，包括以下成分：甲磺酸仑伐替尼、碳酸钙、甘露醇、低取代羟丙基纤维素、羟丙基纤维素、微晶纤维素和滑石粉。所述甲磺酸仑伐替尼中C晶型占15wt％～30wt％，其余为无定型。本发明通过控制制剂中甲磺酸仑伐替尼中C晶型的含量，使得所述制剂具有最佳的溶出效果，批间质量差异也更小，同时对原料药甲磺酸仑伐替尼粒径的要求更低，当甲磺酸仑伐替尼的粒径为D90≤40μm时即可获得粒度分布均匀、装量差异小、溶出效果佳的甲磺酸仑伐替尼制剂。
USPTO Abstract
本发明公开了一种甲磺酸仑伐替尼制剂及其制备方法，属于药物制剂技术领域。本发明所述的甲磺酸仑伐替尼制剂，包括以下成分：甲磺酸仑伐替尼、碳酸钙、甘露醇、低取代羟丙基纤维素、羟丙基纤维素、微晶纤维素和滑石粉。所述甲磺酸仑伐替尼中C晶型占15wt％～30wt％，其余为无定型。本发明通过控制制剂中甲磺酸仑伐替尼中C晶型的含量，使得所述制剂具有最佳的溶出效果，批间质量差异也更小，同时对原料药甲磺酸仑伐替尼粒径的要求更低，当甲磺酸仑伐替尼的粒径为D90≤40μm时即可获得粒度分布均匀、装量差异小、溶出效果佳的甲磺酸仑伐替尼制剂。
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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