JP6257604B2 - アポモルヒネと有機酸とを含む組成物およびその使用 - Google Patents
アポモルヒネと有機酸とを含む組成物およびその使用 Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
Description
本出願は、2012年6月5日に出願された米国仮特許出願第61/655,633号の利益を主張し、その全内容が、参照により本明細書に組み込まれる。
一態様において、本発明は、安定な液状または半固形状医薬組成物、具体的には、アポモルヒネと有機酸とを含む水性医薬組成物に関する。有機酸としては、例えばアミノ酸、カルボン酸、およびジカルボン酸が挙げられるが、これらに限定されない。例えば、請求項に係る組成物における使用が意図されるカルボン酸および/またはジカルボン酸は、少なくとも2つ、3つ、または4つの炭素原子を含んでいてもよく、例えば酒石酸であってもよい。請求項に係る組成物における使用が意図されるジカルボン酸は、親水性であってもよく、また、例えばヒドロキシル基などの親水基で置換されていてもよい。
方法
キット
皮下投与用のアポモルヒネ塩溶液またはアポモルヒネ製剤の調製
皮下投与用のアポモルヒネ塩溶液またはアポモルヒネ製剤の調製
インビトロにおけるアポモルヒネ塩溶液の物理的安定性
皮下投与用のアポモルヒネ塩溶液またはアポモルヒネ製剤の調製
生体外における、豚皮の全層への持続皮下注射後に発生するアポモルヒネ依存のSC(皮下組織)への汚着に対する製剤組成物の影響
実施例6
アポモルヒネのグルタミン酸塩、アスパラギン酸塩、および酒石酸塩の調製
実施例7
Tween80を用いたグルタミン酸アポモルヒネ製剤の調製
グルタミン酸アポモルヒネ溶液と市販の塩酸アポモルヒネ溶液の安定性の比較
実施例9
グルタミン酸アポモルヒネ溶液の安定性に関する製剤成分分析
実施例10
アポモルヒネ製剤の皮下投与後の皮膚炎分析
アポモルヒネ溶液の安定性に対するTween80の影響
実施例12
グルタミン酸アポモルヒネ製剤と塩酸アポモルヒネ製剤の安定性の比較
参照による組込み
Claims (21)
- アポモルヒネと、酸性アミノ酸と、薬学的に許容可能な担体とを含み、アポモルヒネと酸性アミノ酸とのモル比が1:0.5〜1:2.5である、液状または半固形状医薬組成物であって、該組成物が20〜30℃で、24時間、実質的に固形物を析出しないことを特徴とする液状または半固形状医薬組成物。
- アポモルヒネと酸性アミノ酸とのモル比が1:1〜1:1.5である、請求項1に記載の医薬組成物。
- 酸性アミノ酸がアスパラギン酸、グルタミン酸、またはその組合せである、請求項1または2に記載の医薬組成物。
- pHが3より大きい、請求項1〜3のいずれかに記載の医薬組成物。
- 25℃でpHが3.0〜5.5、または4.0〜7.5である、請求項4に記載の医薬組成物。
- 25℃でpHが3.5〜5.0、3.5〜4.5、または4.0〜5.0である、請求項5に記載の医薬組成物。
- 少なくとも1重量%のアポモルヒネを含む、請求項1〜6のいずれかに記載の医薬組成物。
- 1〜4重量%のアポモルヒネを含む、請求項7に記載の医薬組成物。
- 25℃で少なくとも48時間、実質的に固形物を析出しない、請求項1〜8のいずれかに記載の医薬組成物。
- 水性である、請求項9に記載の医薬組成物。
- さらにアミノ糖、塩基性アミノ酸、1以上の抗酸化物質、またはそれらの組合せを含む、請求項1〜10のいずれかに記載の医薬組成物。
- アミノ糖がメグルミンである、もしくは塩基性アミノ酸がアルギニン酸である、または1以上の抗酸化物質がアスコルビン酸、アスコルビン酸ナトリウム、L−システイン、N−アセチルシステイン(NAC)、グルタチオン(GSH)、Na2−EDTA、Na2−EDTA−Ca、または亜硫酸水素ナトリウムからそれぞれ独立に選択される、請求項11に記載の医薬組成物。
- さらに界面活性剤を含む、請求項1〜12のいずれかに記載の医薬組成物。
- 界面活性剤がTween80である、請求項13に記載の医薬組成物。
- さらに局所麻酔薬および/または抗炎症剤を含む、請求項1〜14のいずれかに記載の医薬組成物。
- 局所麻酔薬が、アミド型の局所麻酔薬、またはエステル型の局所麻酔薬であり、抗炎症剤が、非ステロイド系抗炎症剤、またはステロイド系抗炎症剤である、請求項15に記載の医薬組成物。
- 前記のアミド型の局所麻酔薬が、リドカイン、プリロカイン、ブピバカイン、レボブピバカイン、ロピバカイン、メピバカイン、ジブカイン、もしくはエチドカインであり、前記のエステル型の局所麻酔薬が、プロカイン、アメトカイン、コカイン、ベンゾカイン、もしくはテトラカインであり、前記の非ステロイド系抗炎症剤が、ジクロフェナク、ケトロラク、サリチル酸イブプロフェン、ピロキシカム、もしくはベンジダミンであり、または前記のステロイド系抗炎症剤が、プレドニゾン、デキサメタゾン、ベータメタゾン、プレドニゾンヒドロコルチゾン、もしくはそれらの塩である、請求項16に記載の医薬組成物。
- 皮下投与、静脈内投与、経鼻投与、経皮投与、舌下投与、筋肉内投与、経口投与、点眼、または気管内投与用に調合されている、請求項1〜17のいずれかに記載の医薬組成物。
- 神経学的もしくは運動性の疾患もしくは障害、またはそれらに関連する状態の治療のための、請求項1〜18のいずれかに記載の液状または半固形状医薬組成物。
- 前記の神経学的または運動性の疾患または障害が、パーキンソン病、アルツハイマー病、または無動症であり、該神経学的疾患または障害に関連する前記の状態が、アルコール依存症、アヘン中毒、または勃起障害である、請求項19に記載の液状または半固形状医薬組成物。
- パーキンソン病治療のための、請求項20に記載の液状または半固形状医薬組成物。
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Application Number | Priority Date | Filing Date | Title |
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US201261655633P | 2012-06-05 | 2012-06-05 | |
US61/655,633 | 2012-06-05 | ||
PCT/IL2013/050487 WO2013183055A1 (en) | 2012-06-05 | 2013-06-05 | Compositions comprising apomorphine and organic acids and uses thereof |
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JP2017233819A Division JP6458124B2 (ja) | 2012-06-05 | 2017-12-05 | アポモルヒネと有機酸とを含む組成物およびその使用 |
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JP2015518880A JP2015518880A (ja) | 2015-07-06 |
JP2015518880A5 JP2015518880A5 (ja) | 2016-07-21 |
JP6257604B2 true JP6257604B2 (ja) | 2018-01-10 |
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JP2017233819A Expired - Fee Related JP6458124B2 (ja) | 2012-06-05 | 2017-12-05 | アポモルヒネと有機酸とを含む組成物およびその使用 |
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US (3) | US9999674B2 (ja) |
EP (2) | EP2854764B1 (ja) |
JP (2) | JP6257604B2 (ja) |
CN (2) | CN107693486A (ja) |
AU (1) | AU2013273138B2 (ja) |
BR (1) | BR112014030265A2 (ja) |
CA (1) | CA2875446A1 (ja) |
DK (1) | DK2854764T3 (ja) |
ES (1) | ES2715028T3 (ja) |
HU (1) | HUE042425T2 (ja) |
MX (1) | MX2014014902A (ja) |
NZ (1) | NZ703341A (ja) |
PL (1) | PL2854764T3 (ja) |
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CN107693486A (zh) | 2018-02-16 |
US9381249B2 (en) | 2016-07-05 |
WO2013183055A1 (en) | 2013-12-12 |
PT2854764T (pt) | 2019-03-21 |
ES2715028T3 (es) | 2019-05-31 |
AU2013273138A1 (en) | 2015-01-22 |
CA2875446A1 (en) | 2013-12-12 |
AU2013273138B2 (en) | 2017-06-15 |
JP2015518880A (ja) | 2015-07-06 |
HUE042425T2 (hu) | 2019-06-28 |
BR112014030265A2 (pt) | 2017-06-27 |
US20150182523A1 (en) | 2015-07-02 |
JP6458124B2 (ja) | 2019-01-23 |
DK2854764T3 (en) | 2019-04-08 |
EP2854764A1 (en) | 2015-04-08 |
EP2854764B1 (en) | 2018-12-12 |
MX2014014902A (es) | 2015-03-04 |
RU2688672C2 (ru) | 2019-05-22 |
NZ703341A (en) | 2016-11-25 |
EP3456315A1 (en) | 2019-03-20 |
US9999674B2 (en) | 2018-06-19 |
CN104349768B (zh) | 2017-11-07 |
JP2018070633A (ja) | 2018-05-10 |
PL2854764T3 (pl) | 2019-07-31 |
ZA201409516B (en) | 2016-03-30 |
US20160067339A1 (en) | 2016-03-10 |
CN104349768A (zh) | 2015-02-11 |
US10525134B2 (en) | 2020-01-07 |
RU2014152208A (ru) | 2016-07-27 |
US20180303939A1 (en) | 2018-10-25 |
TR201903492T4 (tr) | 2019-04-22 |
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