JP2022510864A - 凍結乾燥物容器および点滴キット - Google Patents
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Abstract
Description
Claims (16)
- 凍結乾燥物容器(3;30;36;37;38;39)であって、
コンパートメントと、
前記コンパートメントを限定する壁(31、32、33;310、320、330;336;318、328;3119、3129)と、
前記コンパートメント内側に配された凍結乾燥物(34;350;326;317;338;379)とを備え、
前記壁(31、32、33;310、320、330;336;318、328;3119、3129)の少なくとも一部分が、半透過性であり、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記コンパートメントから出る一方向の蒸気透過を可能にし、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記コンパートメントに入る反対方向の蒸気透過を防止する、凍結乾燥物容器(3;30;36;37;38;39)。 - 前記壁(31、32、33;310、320、330;336;318、328;3119、3129)が、前記一方向に蒸気透過性であり、他方向に蒸気密封性である半透過性膜を備える、請求項1に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 前記壁(31、32、33;310、320、330;336;318、328;3119、3129)が、フレーム構造(3119)を備え、該フレーム構造(3119)によって前記半透過性膜が広げられる、請求項2に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 外側収納部(329)と、前記外側収納部(329)内側に配置された内側収納部(319)とを備え、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)が、前記内側収納部(319)の一部分である、請求項1から3のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 前記コンパートメントが、前記外側収納部(329)と前記内側収納部(319)との間に配され、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)の前記少なくとも一部分が、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記コンパートメントから前記内側収納部(319)への前記一方向の蒸気透過を可能にし、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記内側収納部(319)から前記コンパートメントへの前記反対方向の蒸気透過を防止するように配向される、請求項4に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 前記コンパートメントが、前記内側収納部(319)内に配され、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)の前記少なくとも一部分が、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記コンパートメントから前記外側収納部(329)と前記内側収納部(319)との間への前記一方向の蒸気透過を可能にし、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記外側収納部(329)と前記内側収納部(319)との間から前記コンパートメントへの前記反対方向の蒸気透過を防止するように配向される、請求項4に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 前記外側収納部(329)または前記内側収納部(319)が、円錐状の横方向領域を有する、請求項4から6のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 孔を有する剛性本体(31;310)を備え、前記孔は、前記本体の一方の端側において開き、前記本体の前記一方の端側から前記本体の他の端側に延び、前記孔は前記コンパートメントを形成し、前記半透過性膜は、前記本体(31;310)に取り付けられ、それによって前記本体(31;310)の前記一方の端側において前記孔を閉じる、請求項2または3に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 高い熱伝導率を有する不透過性ホイル(33;330;336)を備え、前記ホイルは、前記本体(31;310)に取り付けられ、それによって前記本体(31;310)の前記他方の端側において前記貫通孔を閉じる、請求項8に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 前記本体(31;310)が、円錐状の横方向領域を有する、請求項8または9に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- パッド様構造であり、前記コンパートメントが、2つのシート(318、328)間に形成され、前記2つのシートの少なくとも1つが、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)である、請求項1から3のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 前記凍結乾燥物(34;350;326;317;338;379)が、凍結乾燥された薬物製剤であり、特に、前記凍結乾燥物(34;350;326;317;338;379)は、極めて効能がある薬物製剤であり、より具体的には、前記凍結乾燥された薬物製剤は、生物学的成分を含む、請求項1から11のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)。
- 請求項1から12のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)と、前記凍結乾燥物容器(3;30;36;37;38;39)内に配置された凍結乾燥された薬物製剤と、再構成液体で充填された第1のコンパートメント(21;216;217;219)およびポート(23;240;226;256;247)を有する可撓性容器(2;20;26;27)とを備える点滴キットであって、具体的には、前記可撓性容器は、脆弱シール(230)によって前記第1のコンパートメント(21;216;217;219)から分離された第2のコンパートメント(220;229)を備え、前記凍結乾燥物容器(3;30;36;37;38;39)は、前記可撓性容器(2;20;26;27)の前記第2のコンパートメント(220;229)内に配され、より具体的には、前記凍結乾燥物容器(3;30;36;37;38;39)は、前記可撓性容器(2;20;26;27)の前記ポート(23;240;226;256;247)内に取り入れられる、点滴キット。
- 前記ポートが、第1の装着構造を有し、前記凍結乾燥物容器(3;30;36;37;38;39)が、対応する第2の装着構造を有し、それによって前記凍結乾燥物容器(3;30;36;37;38;39)は、前記凍結乾燥物容器(3;30;36;37;38;39)を通して液体を排出するために前記可撓性容器(2;20;26;27)に装着可能となる、請求項13に記載の点滴キット。
- 請求項1から12のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)を準備する方法であって、
前記凍結乾燥物容器(3;30;36;37;38;39)のコンパートメントを限定する壁(31、32、33;310、320、330;336;318、328;3119、3129)によって限定された前記コンパートメント内側に湿性物質を配置することであって、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)の少なくとも一部分は、半透過性であり、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記コンパートメントの内側から出る一方向の蒸気透過を可能にし、前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて前記コンパートメントの内側に入る反対方向の蒸気透過を防止する、湿性物質を配置することと、
前記凍結乾燥物容器(3;30;36;37;38;39)の前記コンパートメントを閉じることと、
蒸気が前記壁(31、32、33;310、320、330;336;318、328;3119、3129)を通り抜けて透過して前記コンパートメントの内側から出るように、前記コンパートメント内で前記湿性物質を凍結乾燥することとを含む、方法。 - 請求項1から12のいずれか一項に記載の凍結乾燥物容器(3;30;36;37;38;39)の使用であって、前記凍結乾燥物容器(3;30;36;37;38;39)の凍結乾燥物(34;350;326;317;338;379)を前記凍結乾燥物容器(3;30;36;37;38;39)のコンパートメント内において液体中で再構成することと、前記再構成された凍結乾燥物(34;350;326;317;338;379)を含む液体溶液を前記コンパートメントの壁(31、32、33;310、320、330;336;318、328;3119、3129)を通して濾過することとを含む、凍結乾燥物容器(3;30;36;37;38;39)の使用。
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