JP6489485B2 - 押し出し増強因子を含んでいる乾燥組成物 - Google Patents
押し出し増強因子を含んでいる乾燥組成物 Download PDFInfo
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Description
a.粉末型の生体適合性ポリマー、1つ以上のポリオール類、押し出し増強因子および水性媒体を提供する工程と、
b.上記生体適合性ポリマー、1つ以上のポリオール類、押し出し増強因子および水性媒体を混合して、ペーストを得る工程と、
c.上記ペーストを乾燥する工程と、
を包含する、方法に関する。
「生物活性剤」とは、インビボまたはインビトロで実証可能な、ある程度の薬理作用(有益なものである場合が多い)を提供する任意の作用剤(因子)、薬物、化合物、組成物、または混合物である。したがって、ある作用剤(因子)がヒトまたは動物の身体で細胞組織と相互作用するか、または細胞組織に影響を及ぼすならば、それは生物活性であるとみなされる。本明細書において用いる場合、この用語はさらに、個体において局所的または全身的な作用をもたらす任意の生理学的または薬理学的活性物質を包含する。生物活性剤は、酵素などのタンパク質であってもよい。生物活性剤のさらなる例としては、限定するものではないが、オリゴ糖、多糖、必要に応じてグリコシル化されたペプチド、必要に応じてグリコシル化されたポリペプチド、オリゴヌクレオチド、ポリヌクレオチド、脂質、脂肪酸、脂肪酸エステル、および二次代謝産物を含むか、またはそれらからなる作用剤が挙げられる。生物活性剤は、ヒトまたは他の任意の動物などの個体の処置に関連して、予防、治療のいずれで用いてもよい。
本開示は、適切な量の水性媒体が添加される際に、止血手当に使用するのに適した実質的に均質なペーストを形成する、乾燥組成物に関する。このペーストは、液体成分の添加の際に自然に形成され、すなわちこのようなペーストを形成するのに機械的な撹拌は不要である。
a.粉末型の生体適合性ポリマー、1つ以上のポリオール類、押し出し増強因子、および水性媒体を提供する工程と、
b.生体適合性ポリマー、1つ以上のポリオール類、押し出し増強因子、および水性媒体を混合してペーストを得る工程と、
c.上記ペーストを乾燥させる工程、を包含する方法により調製してもよい。
・ペーストを調製するのにかかる時間が短くなり、例えば出血をより早く止めることができる。
・作業工程が少なくなるので、調製中にペーストの無菌性が損なわれる危険性が低下する。
・ペースト調製が単純になるので、調製中に間違いを起こす危険性が低下する。
・毎回、最適なコンシステンシーのペーストが得られる。
・ペーストの押し出しが容易になり(例えば、シリンジから止血性ペーストを絞り出すのに必要な力が減り)、これによって止血性ペーストの塗布の正確性が向上する。
・溶液中で不安定な生物活性剤を乾燥前のペーストに添加してもよく、これによって、そのような剤が本開示の乾燥組成物中に存在する。
例えば、トロンビンを乾燥前のペーストに添加してもよく、そうすることで、時間がかかり間違いを起こしやすいトロンビン希釈工程が回避される。
本発明の開示は、粉末状の生体適合性剤(この剤を用いてペーストを作る)に関連する。次いで、ペーストを乾燥させて、止血および創傷治癒手当に使用するのに適した乾燥組成物を得る。
本開示の水性媒体は、当業者に公知の止血用途に適したペーストを調製するのに適する任意の水性媒体、例えば水、生理食塩水、塩化カルシウム溶液、または緩衝化水性媒体であってもよい。水は、WFI(注射用水)であってもよい。再構成されたペースト生成物の等張性が、ヒトまたは動物の被験体に用いるのに適するように、水性媒体を選択する。
本開示に従って、組成物を乾燥する前の組成物に1つ以上のポリオール類が添加される。1つ以上のポリオール類は、水性媒体の形態で液体(水など)を添加すると、どのような種類の機械混合も撹拌も用いることなく、自然に再構成されて止血目的に最適なコンシステンシーのペーストを形成する、乾燥組成物を得る上で役割を果たす。
特定の押し出し増強因子、例えば、適切な量のアルブミンの提供によって、例えば、それによって、例えば、シリンジからゼラチンペースト組成物を押し出すために必要な力の量が減るので、より高濃度のゼラチン使用が可能になる。より高濃度のゼラチンの使用は、やがて、このような生成物の止血性特性を改善し得る。押し出し増強因子を適切な量で提供することが必要である。この量は、止血性ペースト組成物が、例えば、アプリケーター先端部を備えるシリンジを用いて外科医によって正確に塗布され得るように、押し出し効果を得るために、すなわち、比較的大量の生体適合性ポリマー、例えば、架橋ゼラチンについてさえ流動性のペーストを可能にするために、十分高くあるべきであり、もう一方では、その量は、止血性組成物の負の機能的な特性を妨げるほど低くあるべきである。
本開示の一実施形態において、乾燥組成物は、1つ以上の生物活性剤を含む。生物活性剤がその生物活性を保持すること、すなわち生物活性剤が乾燥組成物の再構成後のペーストにおいて生物活性であることが、必須である。多くの生物活性剤が溶液中で不安定であり、特に酵素および他のタンパク質は、水が存在すると、分解してしまうか、その二次構造を失ってしまう可能性がある。
本開示の乾燥組成物は、以下:DMSO(ジメチルスルホキシド)、2−メチル−2,4−ペンタンジオール(MPD)のうち1つ以上、および/または以下の表に挙げられる化合物のうち1つ以上を、さらに含んでもよい。
本開示の方法に従って、生体適合性ポリマー、押し出し増強因子および1つ以上のポリオール類を、適切な水性媒体と混合してペーストを得る。混合は、当業者に公知の任意の適切な方法で、例えば、内容物を手作業で混合することにより、または電動混合装置(ハンドミキサー、キッチンミキサー、または業務用ミキサーなど)を用いることより、行ってもよい。
ペーストの調製および乾燥中のペーストの保持には、当業者に公知の任意の適切な容器(バイアル、ジャー、チューブ、トレイ、カートリッジ、またはシリンジなど)を用いてもよい。
一実施形態において、上記乾燥組成物は、シート型、すなわち、実質的に平坦な組成物である。
本開示に従って、上記ペーストを乾燥させて、乾燥組成物を得る。このペーストは、当業者に公知の任意の適切な方法で乾燥させてもよい。適切な乾燥方法の例としては、凍結乾燥および噴霧乾燥が挙げられる。
ある別の実施形態において、本開示の乾燥組成物は、噴霧乾燥によって得られる。当業者に公知の任意の噴霧乾燥技術および装置が適用されてもよい。
一実施形態において、乾燥組成物は、例えばシリンジまたは他の収容ユニットに収容された状態で、さらに外側包装材に収容され、それにより、その乾燥製品は使用時まで無菌に保たれる。そうすると、使用者は、外側包装を取り去って乾燥組成物を無菌の場所へ移すことが可能になる。そこで、適切な量の水性媒体を加えてもよく、添加されると、すぐに使えるペーストが、機械的な振盪、撹拌、または混合をまったく必要とせずに、数秒以内に自然に形成される。
本開示の乾燥組成物は、好ましくは、無菌である。当該分野で公知の任意の適切な滅菌技術を利用してもよい。滅菌は、好ましくは、包装工程後、すなわち乾燥組成物が外側包装材に収容されたときに行われる。したがって、好適な実施形態において、滅菌は、最終滅菌である。
本開示の乾燥組成物は、適切な量の水性媒体の添加によって再構成され得る。ペーストを再構成するために用いられる水性媒体は、例えば、水、生理食塩水、CaCl2溶液または緩衝化水溶液から選択されてもよい。
a.必要に応じて押し出し増強因子を含んでいる、本明細書に記載の乾燥組成物を提供する工程と、
b.水性媒体を乾燥組成物に添加する工程と、
を包含する、方法に関する。
本開示はさらに、乾燥組成物またはその乾燥組成物から得られるペーストの、止血および/または創傷治癒を促進するための使用に関する。
本開示はさらに、乾燥組成物および乾燥組成物の量に合致した量の水性媒体を備えており、水性媒体が添加されると、適したコンシステンシーのペーストが自然に、すなわち数秒以内に形成されるような、キットに関する。好ましくは、このキットは、止血の促進で使用するため、またはその必要な個体において創傷、骨、腱および/もしくは組織の治癒に使用するためである。
a)本開示の方法により得られた乾燥組成物の入った容器と、
b)水性媒体の入った容器と、
c)必要に応じて外側包装材と。
材料
50gのゼラチン粉末(架橋ゼラチンスポンジを微粉砕したもの)
200mlの緩衝液
ポリオール類
50%塩化ベンザルコニウム(BAC)
0.9%生理食塩水
凍結乾燥機:Leybold−Heraus、Lyovac GT2またはChrist Alpha 1−4 LSC
ミキサー:Kenwood、Major KM616
緩衝液:
2.0g±0.1gのBAC(50%)を青キャップの250mLビンに入れる
BACに98.0g±0.5gの生理食塩水を加える
磁気撹拌子を用いて2分間混合する−これがBACストック溶液である
123.0g±0.5gのグリセロールを2000mLメスフラスコに入れる
10g±0.5gのBACストック溶液を加える
2000mLの印まで生理食塩水を加える
フラスコに栓をして、数回上下をひっくり返す
磁気撹拌子で5±1分間混合する。
ミキサーで撹拌しながら、緩衝液200mlにxgのポリオール(類)を溶解する。溶解したポリオール(類)に50gのゼラチン粉末を加え、均質なペーストが得られるまで、約5分間、混合する。ペーストの混合は、室温(約20℃)で行った。
得られるペーストを、10mlの使い捨てプラスティックシリンジに充填し(シリンジ1本あたり5.5ml)、最低でも4時間−30℃下に置く。凍結したペーストを凍結乾燥機に移し、乾燥するまで15時間凍結乾燥させる。
各シリンジに液体8mlを加えること、すなわち、凍結乾燥プロセス中に組成物から除去された量の水を加えることによって、乾燥組成物を再構成させる。機械的な混合または撹拌は行わなかった。水を乾燥組成物に単に加えただけであって、ペーストが再形成されるまで組成物には手を触れずに放置した。
様々な配合について、再構成にかかる時間、すなわちどのような種類の機械的振盪撹拌もせずに、止血目的に適したペーストが自然に形成されるのに必要な時間を試験した。*3連で決定。
配合5は、5秒で自然に再構成された。配合5の内容を、それぞれ、ペースト(湿潤下)および乾燥組成物(乾燥下)について、以下の表に明記する。
実施例1に記載の方法に従って、ペーストを作り、乾燥させ、再構成させた。ペーストの内容を以下の表に示す。
実施例1に記載の方法に従って、ペーストを作り、乾燥させ、再構成させ、ただし実施例1の緩衝液の代わりに水を用いた。ペーストの内容を以下の表に示す。
実施例1に記載の方法に従って、ペーストを作り、乾燥させ、再構成させた。ペーストの内容を以下の表に示す。
実施例1の配合5のペーストには、トロンビンを、2500IU/生成物(8ml)の理論濃度で含んだ。そのペーストは、実施例1に記載のとおり、室温(約20℃)で作って、混合した。
基本的に実施例1に記載のとおり、様々なポリオール類を含むペーストを作り、乾燥させ、再構成させ、ただし実施例1の緩衝液の代わりにBACを含むH2Oを用いた。ペーストの内容を以下の表に示す。
Claims (21)
- 10%(w/w)〜60%(w/w)の1つ以上の糖アルコールを含む、止血および創傷治癒に用いるための乾燥組成物を調製する方法であって:
a.粉末型の架橋された生体適合性ポリマー、1つ以上の糖アルコール、アルブミンおよび水性媒体を提供する工程と、
b.生体適合性ポリマー、1つ以上の糖アルコール、アルブミンおよび水性媒体を混合して、ペーストを得る工程と、
c.前記ペーストを凍結乾燥する工程と、
いう連続工程を包含する、方法。 - アルブミンがヒト血清アルブミンである、請求項1に記載の方法。
- 乾燥前の前記ペーストが、0.1%(w/w)〜10%(w/w)の量でアルブミンを含む、請求項1または2に記載の方法。
- 乾燥前の前記ペーストが、0.5%(w/w)〜5.0%(w/w)の量でアルブミンを含む、請求項1から3のいずれか一項に記載の方法。
- 前記乾燥組成物が、20%(w/w)〜50%(w/w)の1つ以上の糖アルコールを含む、請求項1〜4のいずれか1項に記載の方法。
- 乾燥前の前記ペーストが、3%(w/w)〜20%(w/w)の1つ以上の糖アルコールを含む、請求項1〜5のいずれかに記載の方法。
- 前記生体適合性ポリマーが、架橋されたスポンジから得られる、請求項1〜6のいずれか1項に記載の方法。
- 前記生体適合性ポリマーがゼラチンである、請求項1〜7のいずれか1項に記載の方法。
- 乾燥前の前記ペーストが:
a.5%(w/w)〜20%(w/w)の1つ以上の糖アルコールと、
b.0.5%(w/w)〜5%(w/w)のアルブミンと、
c.15%(w/w)〜25%(w/w)の生体適合性ポリマーと、
d.60%(w/w)〜80%(w/w)の水と、
を含む、請求項1〜8のいずれか1項に記載の方法。 - 前記乾燥組成物が、5%(w/w)未満の水を含む、請求項1〜9のいずれか1項に記載の方法。
- 前記1つ以上の糖アルコール類が、グリコール、グリセロール、エリスリトール、トレイトール、アラビトール、キシリトール、リビトール、マンニトール、ソルビトール、ズルシトール、フシトール、イジトール、イノシトール、ボレミトール、イソマルト、マルチトール、ラクチトール、およびポリグリシトールからなる群より選択される、請求項1〜10のいずれか一項に記載の方法。
- 前記1つ以上の糖アルコールが、マンニトールおよび必要に応じて1つ以上のさらなるポリオール類である、請求項1〜11のいずれか1項に記載の方法。
- 前記乾燥組成物がさらに、止血、または創傷、骨、腱および/または組織治癒を刺激する1つ以上の生理活性剤を含む、請求項1〜12のいずれか1項に記載の方法。
- 前記生理活性剤がトロンビンである、請求項13に記載の方法。
- 前記水性媒体が、水、生理食塩水、塩化カルシウム溶液、および緩衝化水性媒体からなる群より選択される、請求項1〜14のいずれか1項に記載の方法。
- 前記方法が、外側包装材中へ乾燥組成物を入れるさらなる工程を包含する、請求項1〜15のいずれか1項に記載の方法。
- 前記方法が、乾燥組成物を滅菌するさらなる工程を包含する、請求項1〜16のいずれか1項に記載の方法。
- 前記ペーストが、ペースト型で組成物を分散させるために適切なアプリケーターへ充填され、アプリケーター内で乾燥される、請求項1〜17のいずれか1項に記載の方法。
- 前記乾燥組成物が、再構成して、30秒未満で、機械的混合なしにペーストを形成する、請求項1〜18のいずれか1項に記載の方法。
- 乾燥組成物を再構成するための方法であって、
a.請求項1〜19のいずれか一項に記載の方法で得られる乾燥組成物を提供する工程と、
b.前記乾燥組成物に水性媒体を添加することでペーストを形成する工程と、
を包含する、方法。 - 前記乾燥組成物が、シリンジ内に存在する、請求項20に記載の方法。
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