JP2013515041A - 非結晶形態のロチゴチンの固体分散体を安定化するためのポリビニルピロリドン - Google Patents
非結晶形態のロチゴチンの固体分散体を安定化するためのポリビニルピロリドン Download PDFInfo
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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Abstract
Description
上記した重量割合の倍数も本願発明により包含されることが当業者により認識されるであろう。すなわち、ロチゴチンのポリビニルピロリドンに対する9:4の重量割合はまた、例えば、18:8の重量割合を包含し、ロチゴチンのポリビニルピロリドンに対する9:3.5の重量割合はまた、例えば13.5:5.25の重量割合を包含する。
a)40と250MPの間の複素粘度を有する粘着剤:サンプルフィルムの厚み:約2mm;負荷:5%;ギャップ:1.5mm;および
b)1と10MPの間の複素粘度を有する粘着剤:サンプルフィルムの厚み:約3mm;負荷:1%;ギャップ:2.5mm。
を満たすはずである。
を満足しなければならない。
サンプル調製
PVP溶液
PVP−ロチゴチン−溶液
分析結果
Claims (14)
- ポリビニルピロリドンおよび非結晶形態のロチゴチンを含む固体分散体を提供する工程を含み、ここでロチゴチンのポリビニルピロリドンに対する重量割合が約9:3.5から約9:6の範囲にある、ロチゴチンの安定化方法。
- ロチゴチンのポリビニルピロリドンに対する重量割合が約9:3.5から約9:4.5の範囲にある、請求項1記載の方法。
- 分散剤および分散相を含む固体分散体であって、該分散相がロチゴチンおよびポリビニルピロリドンを含み、ここでロチゴチンのポリビニルピロリドンに対する重量割合が約9:3.5ないし約9:6の範囲にある、固体分散体。
- ロチゴチンがロチゴチン遊離塩基である、請求項3記載の固体分散体。
- ロチゴチンの分散剤中溶解度が1重量%未満である、請求項4記載の固体分散体。
- 分散剤が少なくとも1種のシリコーン感圧粘着剤を含む、請求項3、4または5記載の固体分散体。
- 分散剤が第1シリコーン感圧粘着剤および第2シリコーン感圧粘着剤の混合物を含む固体分散体であって、5と15MPの間の複素粘度を有する、請求項3、4、5または6記載の固体分散体。
- ロチゴチンとポリビニルピロリドンが多数のマイクロリザバー中にある、請求項3、4、5、5または7記載の固体分散体。
- 請求項3、4、5、6、7または8に記載の固体分散体を含む、医薬組成物。
- 少なくとも1種のアミン適合性シリコーン感圧粘着剤を、約0.1ないし約3.15mg/cm2のロチゴチンを遊離塩基の形態にて、およびポリビニルピロリドンを含む経皮治療システムであって、ロチゴチンのポリビニルピロリドンに対する重量割合が約9:3.5から約9:6の範囲にある、経皮治療システム。
- ロチゴチンおよびポリビニルピロリドンが多数のマイクロリザバー中に含まれる、請求項10記載の経皮治療システム。
- 請求項3、4、5、6、7または8に記載の固体分散体を含む、経皮治療システム。
- 0.1ないし約3.15mg/cm2のロチゴチンを遊離塩基の形態にて含み、ロチゴチンのポリビニルピロリドンに対する重量割合が9:4である、請求項12記載の経皮治療システム。
- 分散剤および分散相を含む固体分散体を調製することを含む経皮治療システムの製造方法であって、該分散相がロチゴチンおよびポリビニルピロリドンを含み、ここでロチゴチンのポリビニルピロリドンに対する重量割合が約9:3.5から約9:6の範囲にある、製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US28930209P | 2009-12-22 | 2009-12-22 | |
US61/289,302 | 2009-12-22 | ||
PCT/EP2010/070563 WO2011076879A1 (en) | 2009-12-22 | 2010-12-22 | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
Publications (2)
Publication Number | Publication Date |
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JP2013515041A true JP2013515041A (ja) | 2013-05-02 |
JP5815556B2 JP5815556B2 (ja) | 2015-11-17 |
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JP2012545332A Active JP5815556B2 (ja) | 2009-12-22 | 2010-12-22 | 非結晶形態のロチゴチンの固体分散体を安定化するためのポリビニルピロリドン |
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US (4) | US9925150B2 (ja) |
EP (2) | EP2515887B1 (ja) |
JP (1) | JP5815556B2 (ja) |
KR (3) | KR20160055971A (ja) |
CN (3) | CN104189912A (ja) |
AU (1) | AU2010334805B2 (ja) |
BR (1) | BR112012017737A8 (ja) |
CA (1) | CA2767068C (ja) |
CY (1) | CY1120621T1 (ja) |
DK (1) | DK2515887T3 (ja) |
EA (1) | EA025584B1 (ja) |
ES (1) | ES2679800T3 (ja) |
HK (1) | HK1200335A1 (ja) |
HR (1) | HRP20181173T1 (ja) |
HU (1) | HUE039447T2 (ja) |
IL (1) | IL219091A (ja) |
LT (1) | LT2515887T (ja) |
ME (1) | ME03053B (ja) |
MX (1) | MX2012007326A (ja) |
PL (1) | PL2515887T3 (ja) |
PT (1) | PT2515887T (ja) |
RS (1) | RS57457B1 (ja) |
SI (1) | SI2515887T1 (ja) |
TR (1) | TR201810322T4 (ja) |
WO (1) | WO2011076879A1 (ja) |
Cited By (10)
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JP2015522013A (ja) * | 2012-07-06 | 2015-08-03 | エスケー ケミカルス カンパニー リミテッド | ロチゴチン含有経皮吸収製剤 |
JP2017515872A (ja) * | 2014-05-20 | 2017-06-15 | エルテーエス ローマン テラピー−ジステーメ アーゲー | 界面介在物を含む経皮送達システム |
JP2017524685A (ja) * | 2014-05-20 | 2017-08-31 | エルテーエス ローマン テラピー−ジステーメ アーゲー | 経皮送達システムにおける活性薬剤の放出を調節するための方法 |
JP2018123131A (ja) * | 2017-02-03 | 2018-08-09 | コスメディ製薬株式会社 | ロチゴチン含有経皮吸収型貼付剤 |
JP2019506945A (ja) * | 2016-02-05 | 2019-03-14 | スリーエム イノベイティブ プロパティズ カンパニー | フルオロシリコーン剥離ライナーを備えた経皮薬物送達システム |
WO2019124261A1 (ja) | 2017-12-19 | 2019-06-27 | 久光製薬株式会社 | ロチゴチン含有貼付剤 |
WO2020166298A1 (ja) | 2019-02-15 | 2020-08-20 | 久光製薬株式会社 | ロチゴチン安定化方法 |
US11033723B2 (en) | 2013-07-03 | 2021-06-15 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system comprising an electronic component |
US11389410B2 (en) | 2012-11-22 | 2022-07-19 | Lts Lohmann Therapie-Systeme Ag | Multi-day patch for the transdermal administration of rotigotine |
US11633367B2 (en) | 2014-05-20 | 2023-04-25 | Lts Lohmann Therapie-Systeme Ag | Transdermal delivery system containing rotigotine |
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DE19814084B4 (de) | 1998-03-30 | 2005-12-22 | Lts Lohmann Therapie-Systeme Ag | D2-Agonist enthaltendes transdermales therapeutisches System zur Behandlung des Parkinson-Syndroms und Verfahren zu seiner Herstellung |
DE10234673B4 (de) | 2002-07-30 | 2007-08-16 | Schwarz Pharma Ag | Heißschmelz-TTS zur Verabreichung von Rotigotin und Verfahren zu seiner Herstellung sowie Verwendung von Rotigotin bei der Herstellung eines TTS im Heißschmelzverfahren |
DE10334187A1 (de) * | 2003-07-26 | 2005-03-03 | Schwarz Pharma Ag | Substituierte 2-Aminotetraline zur Behandlung von Depressionen |
DE10334188B4 (de) * | 2003-07-26 | 2007-07-05 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung von Depressionen |
DE10359528A1 (de) * | 2003-12-18 | 2005-07-28 | Schwarz Pharma Ag | (S)-2-N-Propylamino-5-hydroxytetralin als D3-agonistisches Therapeutikum |
US20050197385A1 (en) * | 2004-02-20 | 2005-09-08 | Schwarz Pharma Ag | Use of rotigotine for treatment or prevention of dopaminergic neuron loss |
CN101970422B (zh) * | 2007-11-28 | 2014-10-22 | Ucb制药有限公司 | 罗替高汀的多晶型物 |
EP2281559A1 (en) | 2009-06-26 | 2011-02-09 | UCB Pharma GmbH | Pharmaceutical composition comprising rotigotine salts (acid or Na), especially for iontophoresis |
HUE039447T2 (hu) | 2009-12-22 | 2018-12-28 | Ucb Biopharma Sprl | Polivinilpirrolidon rotigotin nem kristályos formája szilárd diszperziójának stabilizálására |
WO2012084969A1 (en) | 2010-12-22 | 2012-06-28 | Hexal Ag | Adhesive composition containing rotigotine and transdermal therapeutic system comprising the adhesive composition |
EP2559435A1 (en) | 2011-08-19 | 2013-02-20 | UCB Pharma GmbH | Rotigotine in the treatment of hemispatial neglect, stroke and deficits following stroke |
WO2013075823A1 (en) | 2011-11-22 | 2013-05-30 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermal therapeutic system comprising rotigotine and crystallization inhibitor |
DE102011119043A1 (de) | 2011-11-22 | 2013-05-23 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermales therapeutisches System (TDS) mit Rotigotin |
DE102012013421A1 (de) | 2012-07-03 | 2014-01-09 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermales therapeutisches System (TTS) mit Rotigotin |
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JP6180520B2 (ja) | 2012-07-05 | 2017-08-16 | エスケー ケミカルス カンパニー リミテッド | ロチゴチンを含有した経皮吸収製剤(Transdermalcompositioncomprisingrotigotine) |
KR102364378B1 (ko) * | 2014-05-21 | 2022-02-16 | 에스케이케미칼 주식회사 | 안정성을 향상시킨 로티고틴 함유 경피흡수제제 |
DE102014114282A1 (de) * | 2014-10-01 | 2016-04-07 | Neuraxpharm Arzneimittel Gmbh | Transdermales therapeutisches System mit Rotigotin zur Behandlung von Morbus Parkinson |
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