JP2012211150A - ボツリヌス神経毒を含む医薬組成物 - Google Patents
ボツリヌス神経毒を含む医薬組成物 Download PDFInfo
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- JP2012211150A JP2012211150A JP2012128597A JP2012128597A JP2012211150A JP 2012211150 A JP2012211150 A JP 2012211150A JP 2012128597 A JP2012128597 A JP 2012128597A JP 2012128597 A JP2012128597 A JP 2012128597A JP 2012211150 A JP2012211150 A JP 2012211150A
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- botulinum neurotoxin
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Abstract
【解決手段】本発明は、ボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)及び界面活性剤を含む、固体または液体医薬組成物に関する。特に、本発明は、結晶性作用物質を含む、固体または液体医薬組成物に関する。
【選択図】なし
Description
(a)ボツリヌス毒素、及び
(b)界面活性剤
を含む、固体又は液体医薬組成物にも関する。
(a)ボツリヌス毒素、及び
(b)界面活性剤
から成る。
(a)ボツリヌス毒素、
(b)界面活性剤、及び
(c)水
から成る。
該溶液は、溶液1mlあたり、50〜10,000LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、好ましくは、溶液1mlあたり、50〜3,000LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、より好ましくは、溶液1mlあたり、100〜2,500LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、そして最も好ましくは、溶液1mlあたり、100〜2,000LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)を含み;
界面活性剤の濃度は、臨界ミセル濃度〜1%v/vの濃度、特にポリソルベート80の場合には、約0.005%〜0.02%v/vである。
(a)ボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、
(b)界面活性剤、
(c)結晶性作用物質、
(d)pHを5.5〜7.5に維持するための緩衝剤
を含む固体又は液体医薬組成物に関する。
該溶液は、溶液1mlあたり、50〜10,000LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、好ましくは、溶液1mlあたり、50〜3,000LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)[を該溶液は含み]、より好ましくは、溶液1mlあたり、100〜2,500LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、そして最も好ましくは、溶液1mlあたり、100〜2,000LD50単位のボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)を含み;
界面活性剤の濃度は、臨界ミセル濃度〜1%v/v、そして特にポリソルベート80の場合、約0.005%〜0.02%v/vであり;
結晶性作用物質の濃度は、0.1〜0.5M、より好ましくは0.1〜0.4M、特に、約0.15〜0.3Mであり;そして、
緩衝剤の濃度は、1〜50mM、より好ましくは5〜20mM、特に約10mMである。
から選ばれる病気/状態/症候群を治療することを目的とする医薬を製造するために使用されることができる。
・皮膚の欠陥;
・顔面非対称;
・眉間のしわ及び顔面のしわを含むしわ;
・下向きに曲がった口;
・脱毛;及び
・体臭
・以下の:眼瞼痙攣、(拘束性または筋性斜視を含む)斜視、弱視、動揺視、保護性眼瞼下垂、角膜保護のための治療的眼瞼下垂、及び上部眼瞼退縮から成る群から選ばれる、眼科の障害;
から成る群から選ばれる病気/状態/症候群を治療することを目的とする医薬の製造のために使用されるかまたは美容的処置を実施するために使用され、ここで、処置される美容的障害は以下の:
・顔面非対称;
・眉間のしわ及び顔面のしわを含むしわ;
・下向きに曲がった口;及び
・脱毛;
から成る群から選ばれる。
・以下の:眼瞼痙攣、及び斜視から成る群から選ばれる、眼科の障害;
から選ばれる病気/状態/症候群を治療することを目的とする医薬を製造するために使用されるか、または以下の:
・顔面非対称;
・眉間のしわ及び顔面のしわを含むしわ;
・下向きに曲がった口;及び
・脱毛;
から成る群から選ばれる美容的障害の美容的処置を実施するために使用される。
マウス毒性アッセイ
マウス毒性アッセイは、ボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)の毒性を測定するために使用可能である。該アッセイにおいては、推定のLD50値または約推定のLD50値の範囲の希釈液を調製するために標準希釈液が使用される。希釈液の範囲及び規模は、正確なLD50値を確立するように用意する。
Claims (11)
- 以下の:
(a)ボツリヌス神経毒複合体(A、B、C、D、E、FまたはG型)または高純度ボツリヌス神経毒(A、B、C、D、E、FまたはG型)、及び
(b)界面活性剤、
を含む、固体または液体医薬組成物。 - さらに、結晶性作用物質を含む、請求項1に記載の固体または液体医薬組成物。
- 上記結晶性作用物質が塩化ナトリウムである、請求項2に記載の固体または液体医薬組成物。
- pHを5.5〜7.5に維持するために、さらに緩衝剤を含む、請求項1〜3のいずれか1項に記載の固体または液体医薬組成物。
- 上記緩衝剤がpHを5.8〜7.0に維持する、請求項4に記載の固体または液体医薬組成物。
- さらにジサッカライドを含む、請求項1〜5のいずれか1項に記載の固体または液体医薬組成物。
- 上記ジサッカライドが、シュークロース、トレハロース、ラクトース及びマンニトールから成る群から選ばれる、請求項6に記載の固体または液体医薬組成物。
- ボツリヌス神経毒複合体A型を含む、請求項1〜7のいずれか1項に記載の固体または液体医薬組成物。
- 高純度ボツリヌス神経毒A型を含む、請求項1〜7のいずれか1項に記載の固体または液体医薬組成物。
- 上記界面活性剤がポリソルベート80である、請求項1〜9のいずれか1項に記載の医薬組成物。
- 実質的に本明細書中に記載された、固体または液体医薬組成物。
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GB0415491A GB2416122A (en) | 2004-07-12 | 2004-07-12 | Botulinum neurotoxin composition |
GB0415491.0 | 2004-07-12 |
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