JP6649246B2 - タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法 - Google Patents
タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法 Download PDFInfo
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Description
本出願は、米国特許法第119条の下で、2013年3月14日に出願された米国仮特許出願第61/786,035号の利益を主張し、その全体が参照され本明細書に盛り込まれている。
タンパク質
賦形剤
生分解性ポリマーマトリックス
微小球
実施例1
実施例2
実施例3
実施例4
実施例6
実施例7
実施例8
Claims (3)
- 粒子を含む組成物であって、
前記粒子は、タンパク質と、生分解性ポリマーと、スルホブチルエーテル−β−シクロデキストリンと、アルギニンと、
を含み、
前記粒子は2ヶ月以上の期間前記タンパク質を送達するように構成されており、
前記生分解性ポリマーは、0.5dL/g〜0.70dL/gの範囲内の固有粘度を有する、75:25のポリ(d,l−ラクチド−コ−グリコリド)を含み、
前記タンパク質は、ベバシズマブ又はアンチカリンである、
前記組成物。 - 前記タンパク質は10kDa〜150kDaの範囲の分子量を有する、請求項1記載の組成物。
- 水性製剤であって、
タンパク質と、
生分解性ポリマーと、
緩衝剤と、
スルホブチルエーテル−β−シクロデキストリン及びアルギニンと、
を含み、
スルホブチルエーテル−β−シクロデキストリン及びアルギニンは、前記タンパク質のモル濃度に関して、10/1〜200/1の範囲のモル比で前記水性製剤中に存在し、
前記タンパク質は、ベバシズマブ又はアンチカリンであり、
前記生分解性ポリマーは、0.5dL/g〜0.70dL/gの範囲内の固有粘度を有する、75:25のポリ(d,l−ラクチド−コ−グリコリド)を含む、
前記水性製剤。
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