JP2018202126A - 軟質複室バッグおよびその使用方法 - Google Patents
軟質複室バッグおよびその使用方法 Download PDFInfo
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- JP2018202126A JP2018202126A JP2017219188A JP2017219188A JP2018202126A JP 2018202126 A JP2018202126 A JP 2018202126A JP 2017219188 A JP2017219188 A JP 2017219188A JP 2017219188 A JP2017219188 A JP 2017219188A JP 2018202126 A JP2018202126 A JP 2018202126A
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Abstract
【解決手段】薬学的製剤を液体状態で第1のポートを通じて軟質バッグの第1の隔室に導入する。軟質バッグの第1の隔室内で薬学的製剤を凍結乾燥することで、凍結乾燥された薬学的製剤を得る。軟質バッグは第2の隔室を有し、第1の隔室と第2の隔室とは破ることが可能なシールで隔離されている。第2の隔室は、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液をさらに含む。ユーザーは、薬学的製剤を患者に投与するために、圧力を軟質バッグに加えることでシールを破り、凍結乾燥された薬学的製剤と再構成溶液とを混合することができる。
【選択図】図1
Description
凍結乾燥された薬学的製剤を保持するように構成された第1の隔室、および
第1の隔室から隔離されており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成された、第2の隔室
を有する、薬学的軟質バッグを含みうる。
バッグは、
第1の隔室と第2の隔室との間に配置されており、第1の隔室を第2の隔室から隔離および封鎖する、シール
をさらに含みうる。
第1のポートは、第1の隔室に取り付けられており、薬学的製剤を第1の隔室に導入するようにかつ薬学的製剤の凍結乾燥中に薬学的製剤からの水蒸気の通過を可能にするように構成されている。
第2の隔室は、
第2の隔室に取り付けられており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を導入するように構成された、第2のポート
を含みうる。
医療従事者は、シールを破ることで、凍結乾燥された薬学的製剤と再構成溶液とを混合することができる。
[1]
軟質複室バッグ中に薬学的製剤を準備する方法であって、
薬学的製剤を液体状態で第1のポートを通じて軟質バッグの第1の隔室に導入する段階; および
軟質バッグの第1の隔室内で薬学的製剤を凍結乾燥することで、凍結乾燥された薬学的製剤を得る段階
を含み、
軟質バッグが第2の隔室を有し、第1の隔室と第2の隔室とが破ることが可能なシールで隔離されている、方法;
[2]
再構成溶液を軟質バッグの第2の隔室に導入する段階をさらに含む、[1]記載の方法;
[3]
第1の隔室内の薬学的製剤が凍結乾燥された後に、ガスを第1の隔室に導入し、第1のポートを封鎖する段階をさらに含む、[1]記載の方法;
[4]
所定量の圧力を軟質バッグに加えることで第1の隔室と第2の隔室との間の破ることが可能なシールを破る段階; および
第1の隔室内で再構成溶液と凍結乾燥された薬学的製剤とを混合することで、再構成された薬学的製剤を作り出す段階
をさらに含む、[1]記載の方法;
[5]
軟質バッグに配置された投与ポートを通じて最終の薬学的製剤を患者に投与する段階をさらに含む、[4]記載の方法;
[6]
軟質バッグの前面と軟質バッグの背面とを接合することで、破ることが可能なシールが第1の隔室と第2の隔室との間に形成される、[1]記載の方法;
[7]
破ることが可能なシールが弱点部を含み、弱点部において、破ることが可能なシールが、破ることが可能なシールの残りの部分ほど幅広くはなく、
圧力が軟質バッグに加えられる際に、破ることが可能なシールの破れが弱点部において始まる、
[6]記載の方法;
[8]
薬学的製剤が細胞毒性薬である、[1]記載のバッグ;
[9]
細胞毒性薬が、アザシチジン、ベリノスタット、ベンダムスチン、ブレンツキシマブベドチン、ブレオマイシン、ボルテゾミブ、ブスルファン、カルボプラチン、シクロホスファミド、シタラビン、ダカルバジン、ダクチノマイシン、ダウノルビシン、デシタビン、デフェロキサミン、ドキソルビシン、塩酸エピルビシン、フルダラビン、ホテムスチン、フルベストラント、ゲムシタビン、イダルビシン、イホスファミド、塩酸イリノテカン、イクサベピロン、メルファラン、メトトレキサート、オキサリプラチン、パクリタキセル、ペメトレキセド、ペントスタチン、ラルチトレキセド、ロミデプシン、テモゾロミド、チオテパ、トポテカン、トラベクテジン、トラスツズマブ、およびビンブラスチンからなる群より選択される、[8]記載のバッグ;
[10]
再構成溶液が0.9%生理食塩水である、[2]記載のバッグ;
[11]
バッグがポリオレフィン/スチレンブロック共重合体系フィルムから作製される、[1]記載の方法;
[12]
凍結乾燥された薬学的製剤を保持するように構成された第1の隔室;
第1の隔室から隔離されており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成された、第2の隔室;
第1の隔室と第2の隔室との間に配置されており、第1の隔室を第2の隔室から隔離および封鎖する、シール; ならびに
第1の隔室に取り付けられており、薬学的製剤を第1の隔室に導入するように、かつ薬学的製剤の凍結乾燥中に薬学的製剤からの水蒸気の通過を可能にするように構成された、第1のポート
を含む、薬学的軟質バッグ;
[13]
第2の隔室に取り付けられており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を第2の隔室に導入するように構成された、第2のポートをさらに含む、[12]記載の薬学的バッグ;
[14]
シールが、薬学的バッグの前面と薬学的バッグの背面との間の接続部である、[12]記載の薬学的バッグ;
[15]
シールが第1の隔室と第2の隔室との間で薬学的バッグの長さに沿って伸びている、[12]記載の薬学的バッグ;
[16]
薬学的バッグに加えられる所定量の圧力によってシールが破れ、第2の隔室が第1の隔室に接続される、[12]記載の薬学的バッグ;
[17]
シールが、所定量の圧力が薬学的バッグに加えられる際に最初に破れる点を提供する弱点部をさらに含む、[12]記載の薬学的バッグ;
[18]
薬学的製剤が細胞毒性薬である、[12]記載の薬学的バッグ;
[19]
細胞毒性薬が、アザシチジン、ベリノスタット、ベンダムスチン、ブレンツキシマブベドチン、ブレオマイシン、ボルテゾミブ、ブスルファン、カルボプラチン、シクロホスファミド、シタラビン、ダカルバジン、ダクチノマイシン、ダウノルビシン、デシタビン、デフェロキサミン、ドキソルビシン、塩酸エピルビシン、フルダラビン、ホテムスチン、フルベストラント、ゲムシタビン、イダルビシン、イホスファミド、塩酸イリノテカン、イクサベピロン、メルファラン、メトトレキサート、オキサリプラチン、パクリタキセル、ペメトレキセド、ペントスタチン、ラルチトレキセド、ロミデプシン、テモゾロミド、チオテパ、トポテカン、トラベクテジン、トラスツズマブ、およびビンブラスチンからなる群より選択される、[18]記載の薬学的バッグ;
[20]
再構成溶液が0.9%生理食塩水である、[12]記載の薬学的バッグ;
[21]
ポリオレフィン/スチレンブロック共重合体系フィルムから作製される、[12]記載の薬学的バッグ;
[22]
摂氏121度に耐える、[12]記載の薬学的バッグ;
[23]
摂氏-45度に耐える、[12]記載の薬学的バッグ;
[24]
第2の隔室が、凍結乾燥された薬学的製剤と再構成溶液とを混合した結果である再構成された薬学的製剤を投与するための投与ポートをさらに含む、[12]記載の薬学的バッグ;
[25]
前面フィルム;
背面フィルム;
薬学的バッグの周囲で前面フィルムを背面フィルムに接合する、外側シール; ならびに
外側シールの内側で前面フィルムと背面フィルムとを接合し、第1の隔室、および第1の隔室から隔離された第2の隔室を画定する、破ることが可能なシール
を含み、
第1の隔室が、凍結乾燥された薬学的製剤を保持するように構成され、
第2の隔室が、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成され、
所定量の圧力が薬学的軟質バッグに加えられる際に、破ることが可能なシールが外側シールよりも先に破れる、
薬学的軟質バッグ;ならびに
[26]
第1の隔室および第2の隔室が、外側シールおよび破ることが可能なシールによって画定されている、[25]記載の薬学的軟質バッグ。
本発明を、添付図面に示すその態様を参照してここで詳細に説明する。添付図面において、同様の参照数字は、同一または機能的に同様の要素を示すように使用される。「1つの態様」、「一態様」、「例示的な一態様」などに対する言及は、記載される態様が特定の特徴、構造、または特性を含み得るが、すべての態様が特定の特徴、構造、または特性を必ずしも含まないことがあることを示す。さらに、そのような語句は、必ずしも同じ態様を指しているわけではない。さらに、一態様との関連で特定の特徴、構造、または特性が記載されている場合、明示的に記載されている場合であれ、そうでない場合であれ、他の態様との関連でそのような特徴、構造、または特性を実行することが当業者の知識の枠内であると考えられる。
凍結乾燥された薬学的製剤を保持するように構成された第1の隔室、
第1の隔室から隔離されており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成された、第2の隔室、
第1の隔室と第2の隔室との間に配置されており、第1の隔室を第2の隔室から隔離および封鎖する、シール、ならびに
第1の隔室に取り付けられており、薬学的製剤を第1の隔室に導入するように、かつ薬学的製剤の凍結乾燥中に薬学的製剤からの水蒸気の通過を可能にするように構成された、第1のポート
を含む、薬学的軟質バッグを含み得る。
第2の隔室に取り付けられており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を第2の隔室に導入するように構成された、第2のポート
をさらに含み得る。
前面フィルム、背面フィルム、薬学的バッグの周囲で前面フィルムを背面フィルムに接合する、外側シール、ならびに
外側シールの内側で前面フィルムと背面フィルムとを接合し、第1の隔室、および第1の隔室から隔離された第2の隔室を画定する、破ることが可能なシール
を含み得る、薬学的軟質バッグを含み得る。第1の隔室は、凍結乾燥された薬学的製剤を保持するように構成され、第2の隔室は、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成され、所定量の圧力が薬学的軟質バッグに加えられる際に、破ることが可能なシールが外側シールよりも先に破れる。
102 外側シール
104 内側シール
110 第1の隔室
112 ポート
114 コネクタ
116 管
120 第2の隔室
122 ポート
124 ポート
126 ポート
130 シール
132 弱点部
140 ラベル領域
150 孔
500 薬学的製剤
600 凍結乾燥された薬学的製剤
700 再構成溶液
900 再構成された薬学的製剤
Claims (26)
- 軟質複室バッグ中に薬学的製剤を準備する方法であって、
薬学的製剤を液体状態で第1のポートを通じて軟質バッグの第1の隔室に導入する段階;および
軟質バッグの第1の隔室内で薬学的製剤を凍結乾燥することで、凍結乾燥された薬学的製剤を得る段階
を含み、
軟質バッグが第2の隔室を有し、第1の隔室と第2の隔室とが破ることが可能なシールで隔離されている、方法。 - 再構成溶液を軟質バッグの第2の隔室に導入する段階をさらに含む、請求項1記載の方法。
- 第1の隔室内の薬学的製剤が凍結乾燥された後に、ガスを第1の隔室に導入し、第1のポートを封鎖する段階をさらに含む、請求項1記載の方法。
- 所定量の圧力を軟質バッグに加えることで第1の隔室と第2の隔室との間の破ることが可能なシールを破る段階; および
第1の隔室内で再構成溶液と凍結乾燥された薬学的製剤とを混合することで、再構成された薬学的製剤を作り出す段階
をさらに含む、請求項1記載の方法。 - 軟質バッグに配置された投与ポートを通じて最終の薬学的製剤を患者に投与する段階をさらに含む、請求項4記載の方法。
- 軟質バッグの前面と軟質バッグの背面とを接合することで、破ることが可能なシールが第1の隔室と第2の隔室との間に形成される、請求項1記載の方法。
- 破ることが可能なシールが弱点部を含み、弱点部において、破ることが可能なシールが、破ることが可能なシールの残りの部分ほど幅広くはなく;
圧力が軟質バッグに加えられる際に、破ることが可能なシールの破れが弱点部において始まる、請求項6記載の方法。 - 薬学的製剤が細胞毒性薬である、請求項1記載のバッグ。
- 細胞毒性薬が、アザシチジン、ベリノスタット、ベンダムスチン、ブレンツキシマブベドチン、ブレオマイシン、ボルテゾミブ、ブスルファン、カルボプラチン、シクロホスファミド、シタラビン、ダカルバジン、ダクチノマイシン、ダウノルビシン、デシタビン、デフェロキサミン、ドキソルビシン、塩酸エピルビシン、フルダラビン、ホテムスチン、フルベストラント、ゲムシタビン、イダルビシン、イホスファミド、塩酸イリノテカン、イクサベピロン、メルファラン、メトトレキサート、オキサリプラチン、パクリタキセル、ペメトレキセド、ペントスタチン、ラルチトレキセド、ロミデプシン、テモゾロミド、チオテパ、トポテカン、トラベクテジン、トラスツズマブ、およびビンブラスチンからなる群より選択される、請求項8記載のバッグ。
- 再構成溶液が0.9%生理食塩水である、請求項2記載のバッグ。
- バッグがポリオレフィン/スチレンブロック共重合体系フィルムから作製される、請求項1記載の方法。
- 凍結乾燥された薬学的製剤を保持するように構成された第1の隔室;
第1の隔室から隔離されており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成された、第2の隔室;
第1の隔室と第2の隔室との間に配置されており、第1の隔室を第2の隔室から隔離および封鎖する、シール; ならびに
第1の隔室に取り付けられており、薬学的製剤を第1の隔室に導入するように、かつ薬学的製剤の凍結乾燥中に薬学的製剤からの水蒸気の通過を可能にするように構成された、第1のポート
を含む、薬学的軟質バッグ。 - 第2の隔室に取り付けられており、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を第2の隔室に導入するように構成された、第2のポートをさらに含む、請求項12記載の薬学的バッグ。
- シールが、薬学的バッグの前面と薬学的バッグの背面との間の接続部である、請求項12記載の薬学的バッグ。
- シールが第1の隔室と第2の隔室との間で薬学的バッグの長さに沿って伸びている、請求項12記載の薬学的バッグ。
- 薬学的バッグに加えられる所定量の圧力によってシールが破れ、第2の隔室が第1の隔室に接続される、請求項12記載の薬学的バッグ。
- シールが、所定量の圧力が薬学的バッグに加えられる際に最初に破れる点を提供する弱点部をさらに含む、請求項12記載の薬学的バッグ。
- 薬学的製剤が細胞毒性薬である、請求項12記載の薬学的バッグ。
- 細胞毒性薬が、アザシチジン、ベリノスタット、ベンダムスチン、ブレンツキシマブベドチン、ブレオマイシン、ボルテゾミブ、ブスルファン、カルボプラチン、シクロホスファミド、シタラビン、ダカルバジン、ダクチノマイシン、ダウノルビシン、デシタビン、デフェロキサミン、ドキソルビシン、塩酸エピルビシン、フルダラビン、ホテムスチン、フルベストラント、ゲムシタビン、イダルビシン、イホスファミド、塩酸イリノテカン、イクサベピロン、メルファラン、メトトレキサート、オキサリプラチン、パクリタキセル、ペメトレキセド、ペントスタチン、ラルチトレキセド、ロミデプシン、テモゾロミド、チオテパ、トポテカン、トラベクテジン、トラスツズマブ、およびビンブラスチンからなる群より選択される、請求項18記載の薬学的バッグ。
- 再構成溶液が0.9%生理食塩水である、請求項12記載の薬学的バッグ。
- ポリオレフィン/スチレンブロック共重合体系フィルムから作製される、請求項12記載の薬学的バッグ。
- 摂氏121度に耐える、請求項12記載の薬学的バッグ。
- 摂氏-45度に耐える、請求項12記載の薬学的バッグ。
- 第2の隔室が、凍結乾燥された薬学的製剤と再構成溶液とを混合した結果である再構成された薬学的製剤を投与するための投与ポートをさらに含む、請求項12記載の薬学的バッグ。
- 前面フィルム;
背面フィルム;
薬学的バッグの周囲で前面フィルムを背面フィルムに接合する、外側シール; ならびに
外側シールの内側で前面フィルムと背面フィルムとを接合し、第1の隔室、および第1の隔室から隔離された第2の隔室を画定する、破ることが可能なシール
を含み、
第1の隔室が、凍結乾燥された薬学的製剤を保持するように構成され、
第2の隔室が、第1の隔室内の凍結乾燥された薬学的製剤を再構成するための再構成溶液を保持するように構成され、
所定量の圧力が薬学的軟質バッグに加えられる際に、破ることが可能なシールが外側シールよりも先に破れる、
薬学的軟質バッグ。 - 第1の隔室および第2の隔室が、外側シールおよび破ることが可能なシールによって画定されている、請求項25記載の薬学的軟質バッグ。
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