JP5662379B2 - 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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- JP5662379B2 JP5662379B2 JP2012128597A JP2012128597A JP5662379B2 JP 5662379 B2 JP5662379 B2 JP 5662379B2 JP 2012128597 A JP2012128597 A JP 2012128597A JP 2012128597 A JP2012128597 A JP 2012128597A JP 5662379 B2 JP5662379 B2 JP 5662379B2
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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 (18)
- アルブミン及びポリサッカライドを含まない液体医薬組成物であって、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)、
(b)臨界ミセル濃度〜1%v/vの濃度の非イオン性界面活性剤、
(c)塩化ナトリウム、及び
(d)pHを5.5〜7.5に維持するための緩衝剤
を含み、
さらにジサッカライドを含む、前記液体医薬組成物。 - 上記緩衝剤がpHを5.8〜7.0に維持する、請求項1に記載の液体医薬組成物。
- 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1又は2に記載の液体医薬組成物。
- 上記ジサッカライドの濃度が10〜20mMである、請求項1〜3のいずれか1項に記載の液体医薬組成物。
- 上記ジサッカライドの濃度が11.7mMである、請求項4に記載の液体医薬組成物。
- ボツリヌス神経毒複合体A型を含む、請求項1〜5のいずれか1項に記載の液体医薬組成物。
- 高純度ボツリヌス神経毒A型を含む、請求項1〜5のいずれか1項に記載の医薬組成物。
- 溶液1mlあたり、100〜2,000LD50単位のボツリヌス神経毒複合体または高純度ボツリヌス神経毒を含む、請求項1〜7のいずれか1項に記載の液体医薬組成物。
- 500LD50単位のボツリヌス神経毒複合体A型を含む、請求項8に記載の液体医薬組成物。
- 上記非イオン性界面活性剤がポリソルベートである、請求項1〜9のいずれか1項に記載の医薬組成物。
- 上記非イオン性界面活性剤がポリソルベート80である、請求項10に記載の医薬組成物。
- 上記非イオン性界面活性剤がポロキサマーである、請求項1〜11のいずれか1項に記載の液体医薬組成物。
- 滅菌水をさらに含む、請求項1〜12のいずれか1項に記載の液体医薬組成物。
- 上記塩化ナトリウムの濃度が約0.15〜約0.3Mである、請求項1〜13のいずれか1項に記載の液体医薬組成物。
- 上記緩衝剤がコハク酸及びヒスチジンから成る群から選ばれる、請求項1〜14のいずれか1項に記載の液体医薬組成物。
- 上記緩衝剤がヒスチジンである、請求項15に記載の液体医薬組成物。
- 上記緩衝剤の濃度が5〜20mMである、請求項1〜16のいずれか1項に記載の液体医薬組成物。
- 上記緩衝剤の濃度が10mMである、請求項17に記載の液体医薬組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0415491.0 | 2004-07-12 | ||
GB0415491A GB2416122A (en) | 2004-07-12 | 2004-07-12 | Botulinum neurotoxin composition |
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JP2007520876A Division JP5301830B2 (ja) | 2004-07-12 | 2005-07-06 | ボツリヌス神経毒を含む医薬組成物 |
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JP2012128597A Active JP5662379B2 (ja) | 2004-07-12 | 2012-06-06 | ボツリヌス神経毒を含む医薬組成物 |
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US (4) | US9125804B2 (ja) |
EP (4) | EP1817051B2 (ja) |
JP (2) | JP5301830B2 (ja) |
CN (2) | CN102327602B (ja) |
AR (2) | AR049978A1 (ja) |
BR (1) | BRPI0513327B8 (ja) |
CA (1) | CA2572915C (ja) |
DK (3) | DK1817051T4 (ja) |
ES (3) | ES2537312T3 (ja) |
FI (1) | FI1817051T4 (ja) |
GB (1) | GB2416122A (ja) |
HK (2) | HK1102495A1 (ja) |
HU (2) | HUE043301T2 (ja) |
IL (1) | IL180380A (ja) |
MX (1) | MX2007000409A (ja) |
PL (3) | PL2939688T3 (ja) |
PT (3) | PT2939688T (ja) |
RU (1) | RU2407541C2 (ja) |
TR (1) | TR201906275T4 (ja) |
WO (1) | WO2006005910A2 (ja) |
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