JP5555425B2 - 薬剤復元または希釈のための塩化ナトリウム溶液 - Google Patents
薬剤復元または希釈のための塩化ナトリウム溶液 Download PDFInfo
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Description
[実施例]
バタフライカテーテルラインおよびシリンジにおけるBeneFIX(登録商標)関連性RBC凝集反応が時折報告されている。血友病のイヌからの血液における最近の研究により、処方緩衝液中で組み換えヒトFIXの不在下で凝集反応が起こることが証明されている。従って、この研究は、標準的抗凝固剤、様々なBeneFIX(登録商標)成分、およびイオン強度がBeneFIX(登録商標)関連性凝集減少に影響を及ぼすかどうかを調べた。
現在市販されているBeneFIX(登録商標)製剤は非イオン性製剤である。sWFI中で復元されたBeneFIX(登録商標)製剤の投与の間、患者の血液が復元されたBeneFIX(登録商標)と例えば静脈内チュービング中で混合された場合に赤血球集合(即ち、凝集反応)はほとんど観察されない。本発明は、赤血球集合がrFIXではなく製剤と関連し、少なくとも約40mMのNaClを含有する希釈剤を用いることにより防止されることを見出した。少なくとも約40mMのNaClを含有するカスタム希釈剤の設計を補助するために、インビトロの赤血球集合を評価するための確立された方法である、赤血球沈降を測定するために使用できる定量化可能な分析を設計した。血液が生理食塩水中4:5で希釈される修飾Westergren法を、塩溶液または試験溶液(即ち、カスタム希釈剤)で1:4または1:8に希釈された血液中の凝集を評価するために適応させた。
NaCl濃度はBeneFIX(登録商標)を復元するために使用されるものである。
現在市販されているBeneFIX(登録商標)の非イオン性製剤は、患者血液が静脈内チュービング中でBeneFIX(登録商標)と混合された場合に、投与の間に起こり得るインビトロ赤血球凝集と関連する。本発明は、赤血球集合が組み換え第IX因子でなく、製剤と関連し、凝集はBeneFIX(登録商標)を、少なくとも40mM NaClを含有する希釈剤で復元することにより防止できることを見出した。
ヒト血液を4人の異なるドナーから静脈穿刺により、標準的ヘパリン化集合管中に集めた。2.6mLの緩衝液または復元されたBeneFIX(登録商標)タンパク質をシリンジ中に抜き取り、続いて0.6mLのヘパリン添加血液を抜き取ることによりRBC凝集物の形成を試験した。凝集物の混合/沈降挙動がこれらのシリンジにおいて長時間にわたって観察され、デジタルカメラを用いて写真に記録した。
Claims (21)
- 静脈注射用第IX因子製剤を調製する方法であって、25mMから150mMの塩化ナトリウム溶液を、塩化ナトリウムを含まない凍結乾燥第IX因子製剤に添加し、それにより静脈注射用に調製された製剤を得ることを含み、ここで調製された製剤が血漿に関して等張である270mOsm/Lから330mOsm/Lのオスモル濃度を有するか、または血漿に関して低張である220mOsm/Lから270mOsm/Lのオスモル濃度を有するまたは高張である330mOsm/Lから600mOsm/Lのオスモル濃度を有し、その調製された製剤が静脈注射において赤血球凝集反応を防止することを特徴とする、方法。
- 調製された製剤が少なくとも25mEq/LのNa+およびCl−イオンのイオン強度を有する請求項1に記載の方法。
- 調製された製剤が少なくとも30mEq/LのNa+およびCl−イオンのイオン強度を有する請求項1に記載の方法。
- 調製された製剤が少なくとも36mEq/LのNa+およびCl−イオンのイオン強度を有する請求項1に記載の方法。
- 調製された製剤が少なくとも40mEq/LのNa+およびCl−イオンであるイオン強度を有する請求項1に記載の方法。
- 調製された製剤が少なくとも40mEq/LのNa+およびCl−イオンであり、150mEq/L未満のNa+およびCl−イオンであるイオン強度を有する請求項1に記載の方法。
- 調製された製剤が、伝導率で測定すると少なくとも2.5mS/cmであるイオン強度を有する請求項1に記載の方法。
- 調製された製剤が、伝導率で測定すると少なくとも4.0mS/cmであるイオン強度を有する請求項1に記載の方法。
- 塩化ナトリウム溶液が40mMから150mMである請求項1〜8のいずれか1項記載の方法。
- 塩化ナトリウム溶液が36mMから44mMである請求項1〜8のいずれか1項記載の方法。
- 塩化ナトリウム溶液が40mMである請求項1〜8のいずれか1項記載の方法。
- 凍結乾燥第IX因子製剤が、水中で復元された後に、5mMより多いイオン化塩を含有しない請求項7記載の方法。
- 凍結乾燥第IX因子製剤が、水中で復元された後に、25mMより多いイオン化塩を含有しない請求項7記載の方法。
- 塩化ナトリウム溶液添加前に、凍結乾燥第IX因子製剤がヒスチジン、グリシン、シュークロース、およびポリソルベートを含む請求項1〜13のいずれか1項記載の方法。
- 塩化ナトリウム溶液の添加前に、凍結乾燥第IX因子製剤がヒスチジン、グリシン、シュークロース、ポリソルベート、および治療用タンパク質を含む請求項1〜13のいずれか1項記載の方法。
- 塩化ナトリウム溶液の添加前に、凍結乾燥第IX因子製剤がヒスチジン、グリシン、シュークロースおよびポリソルベートを含む請求項1〜15のいずれか1項記載の方法。
- 塩化ナトリウム溶液の添加前に、凍結乾燥第IX因子製剤が、水中で復元された後に:
(a)5mMから30mMのヒスチジン;
(b)0.1Mから0.3Mのグリシン;
(c)0.5から2パーセントのシュークロース;および
(d)0.001から0.05パーセントのポリソルベート
を含む請求項1〜15のいずれか1項記載の方法。 - 塩化ナトリウム溶液の添加前に、凍結乾燥第IX因子製剤が、水中で復元された後に:
(e)50IU/mLから2000IU/mLの第IX因子を含む請求項17記載の方法。 - (a)凍結乾燥ケーキが5mLの水中で復元された後に、溶液が:
(i)5mMから30mMのヒスチジン;
(ii) 0.1Mから0.3Mのグリシン;
(iii)0.5から2パーセントのシュークロース;
(iv) 0.001から0.05パーセントのポリソルベート;および
(v)50IU/mLから2000IU/mLの第IX因子
を含むような、凍結乾燥ケーキを含有するバイアル;
(b)25mMから150mMの塩化ナトリウム溶液;および
(c)復元後、得られた溶液が、血漿に関して等張である270mOsm/Lから330mOsm/Lのオスモル濃度であり、静脈注射に際して赤血球凝集を防止するように、凍結乾燥ケーキを塩化ナトリウム溶液で復元するための使用説明書を含む医薬キット。 - (a)凍結乾燥ケーキが4mLの水中で復元された後に、溶液が:
(i)10mMのヒスチジン;
(ii)0.26Mのグリシン;
(iii)1パーセントのシュークロース;
(iv) 0.005パーセントのポリソルベート80;および
(v)50IU/mLから2000IU/mLの第IX因子
を含むような、凍結乾燥ケーキを含有するバイアル;
(b)40mMの塩化ナトリウム溶液;および
(c)復元後に、得られる溶液が:
(i)8mMのヒスチジン;
(ii)208mMのグリシン;
(iii)0.8%のシュークロース;
(iv) 0.004%のポリソルベート80;
(v)50IU/mLから2000IU/mLの第IX因子;
(vi)40mMのNaCl
を含むように、バイアル中の凍結乾燥ケーキを5mL塩化ナトリウム溶液で復元するための使用説明書を含む請求項19に記載の医薬キット。 - 静脈注射に際しての赤血球凝集反応を防止するための、凍結乾燥第IX因子製剤であるBeneFIX(登録商標)の復元における25mMから150mMの塩化ナトリウム溶液の使用であって、ここで復元されたBeneFIX(登録商標)製剤が、血漿に関して等張である270mOsm/Lから330mOsm/Lのオスモル濃度を有するか、または血漿に関して低張である220mOsm/Lから270mOsm/Lのオスモル濃度を有するまたは高張である330mOsm/Lから600mOsm/Lのオスモル濃度を有するものである、使用。
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US73222105P | 2005-11-01 | 2005-11-01 | |
US60/732,221 | 2005-11-01 | ||
PCT/US2006/042258 WO2007053533A2 (en) | 2005-11-01 | 2006-10-27 | Sodium chloride solution for drug reconstitution or dilution |
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US (4) | US20070135343A1 (ja) |
EP (3) | EP3593790A1 (ja) |
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JP5937523B2 (ja) | 2010-03-01 | 2016-06-22 | サイトダイン インコーポレイテッドCytoDyn, Inc. | 濃縮されたタンパク質製剤およびその使用 |
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CN105283202B (zh) | 2013-03-11 | 2019-04-23 | 安都磁学有限公司 | 用于淋巴结检测的低渗溶液 |
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EP2968498A4 (en) * | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | PREPARATIONS CONTAINING FACTOR IX POLYPEPTIDE |
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AU2005225000A1 (en) * | 2004-03-04 | 2005-09-29 | Wyeth | Lyophilization method to improve excipient crystallization |
KR20110128957A (ko) | 2005-11-01 | 2011-11-30 | 와이어쓰 엘엘씨 | 약물 재구성 또는 희석을 위한 염화나트륨 용액 |
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