JP2014040477A - 医薬組成物 - Google Patents
医薬組成物 Download PDFInfo
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Abstract
インドリルマレイミド誘導体を含む、経口投与に適当な医薬組成物、これらの製造方法および該医薬組成物の使用を提供すること。
【解決手段】
本発明は、インドリルマレイミド誘導体である3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンまたはその薬学的に許容される塩を含む、経口投与に適当な固体医薬組成物、これらの製造方法および該医薬組成物の使用を提供する。
【選択図】なし
Description
1. 処置を必要とする対象における、例えば、上記に示されているTリンパ球および/またはPKCが介在する障害または疾患の予防または処置において使用するための、上記定義のとおりの3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンまたはその薬学的に許容される塩を含む錠剤。
薬剤を希釈剤、結合剤、崩壊剤、流動促進剤(用途1−6)と混合し、自由落下混合機で混合する。この混合物を滑剤(用途7)と再び混合し、直接異なる強度の錠剤に圧縮する。
薬剤を希釈剤、結合剤、崩壊剤、流動促進剤(用途1−6)と混合し、自由落下混合機で混合する。この混合物を滑剤(用途7)と再び混合し、直接異なる強度の錠剤に圧縮する。この方法を介して得ることができる3つの組成物の例を表1aに示す。
次にこれらの錠剤を非機能性コーティング剤でコーティングする。
薬剤を希釈剤、結合剤、崩壊剤、流動促進剤(用途1−5)と混合し、滑剤(用途6)と一緒に混合し、第1の段階で錠剤またはリボンに圧縮し、適当な篩いを介して篩いにかけ、顆粒を得る。この顆粒を希釈剤、結合剤、崩壊剤および流動促進剤(用途7−10)の別の成分と再び混合し、適当な滑剤を混合物に加えた後に錠剤に圧縮する。
Claims (11)
- 3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンまたはその薬学的に許容される塩および少なくとも1種の滑剤を含む経口投与に適当な固体医薬組成物であって、ここで、該組成物が2から15重量%の滑剤を含み、該組成物が錠剤の形態であり、該組成物の総重量が全錠剤核重量である、固体医薬組成物。
- 組成物が全錠剤核重量に基づいて3から10重量%の滑剤を含む、請求項1に記載の組成物。
- 組成物が全錠剤核重量に基づいて5から90重量%の化合物を含む、請求項1に記載の組成物。
- 少なくとも1種の結合剤をさらに含む、請求項1または2に記載の組成物。
- 組成物が全錠剤核重量に基づいて4から40重量%の結合剤を含む、請求項3に記載の組成物。
- 少なくとも1種の増量剤をさらに含む、請求項1から5のいずれかに記載の組成物。
- 崩壊剤、流動促進剤および界面活性剤から選択される少なくとも1種のさらなる賦形剤を含む、請求項1から6のいずれかに記載の組成物。
- 3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンの酢酸塩を含む、請求項1から7のいずれかに記載の組成物。
- 処置の必要な対象におけるTリンパ球および/またはPKCが介在する障害または疾患の予防または処置において使用するための、請求項1から7のいずれかに記載の組成物。
- (a)3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンまたはその薬学的に許容される塩を結合剤、増量剤および所望により、崩壊剤および流動促進剤から選択される少なくとも1種のさらなる賦形剤と混合し;(b)(a)において得られた混合物を混合、緻密化、粉砕、造粒、乾燥または緻密化し;(c)(b)において得られた混合物を滑剤と混合し;(d)打錠し、そして(e)所望によりコーティングすることを含む、請求項1から7のいずれかに記載の錠剤を製造するための方法。
- (a)水溶液中で増量剤、結合剤および所望により崩壊剤を混合し、そして得られた混合物を造粒し;
(b)(a)において得られた顆粒を乾燥および粉砕し、そしてそれらを滑剤と混合し;
(c)所望により3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンまたはその薬学的に許容される塩を増量剤、崩壊剤、流動促進剤、結合剤および滑剤から選択される少なくとも1種のさらなる賦形剤と混合し;
(d)3−(1.H.−インドル−3−イル)−4−[2−(4−メチル−ピペラジン−1−イル)−キナゾリン−4−イル]−ピロール−2,5−ジオンまたはその薬学的に許容される塩を直接または工程(c)で得られた混合物のいずれかを工程(b)において得られた顆粒と、所望により滑剤の存在下で混合し;
(e)工程(b)、(c)または(d)において得られた混合物を打錠し;そして
(f)所望によりコーティングする
ことを含む、請求項1から7のいずれかに記載の錠剤を製造するための方法。
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EP07150347 | 2007-12-21 | ||
EP07150347.8 | 2007-12-21 |
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JP2010538767A Division JP5525453B2 (ja) | 2007-12-21 | 2008-12-19 | 医薬組成物 |
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JP2013236787A Pending JP2014040477A (ja) | 2007-12-21 | 2013-11-15 | 医薬組成物 |
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US (1) | US20100316713A1 (ja) |
EP (1) | EP2240164A2 (ja) |
JP (2) | JP5525453B2 (ja) |
KR (1) | KR20100103625A (ja) |
CN (1) | CN101883558A (ja) |
AR (1) | AR069799A1 (ja) |
AU (1) | AU2008340019B2 (ja) |
BR (1) | BRPI0820839A2 (ja) |
CA (1) | CA2709909A1 (ja) |
CL (1) | CL2008003823A1 (ja) |
CO (1) | CO6382170A2 (ja) |
EC (1) | ECSP10010360A (ja) |
IL (1) | IL205931A0 (ja) |
MA (1) | MA31950B1 (ja) |
MY (1) | MY158293A (ja) |
NZ (1) | NZ586313A (ja) |
PE (1) | PE20091522A1 (ja) |
RU (1) | RU2485951C2 (ja) |
TN (1) | TN2010000243A1 (ja) |
TW (1) | TWI449541B (ja) |
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PE20091522A1 (es) * | 2007-12-21 | 2009-10-29 | Novartis Ag | Composicion farmaceutica solida que contiene 3-(1.h-indol-3-il)-4-[2-(4-metil-piperazin-1-il)-quinazolin-4-il]-quinazolin-4-il]-pirrol-2,5-diona |
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WO2006092255A1 (en) * | 2005-03-01 | 2006-09-08 | Novartis Ag | Pharmaceutical composition comprising an indolylmaleimide derivative |
JP2010538767A (ja) * | 2007-09-17 | 2010-12-16 | フィットネス エニウェア インク. | 範囲が制限された非弾性訓練装置 |
JP5525453B2 (ja) * | 2007-12-21 | 2014-06-18 | ノバルティス アーゲー | 医薬組成物 |
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TWI324064B (en) * | 2002-04-03 | 2010-05-01 | Novartis Ag | Indolylmaleimide derivatives |
CA2611155A1 (en) * | 2005-06-02 | 2006-12-07 | Schering Corporation | Pharmaceutical formulations and methods of treatment using the same |
US20070042034A1 (en) * | 2005-07-22 | 2007-02-22 | Myriad Genetics, Incorporated | High drug load formulations and dosage forms |
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2008
- 2008-12-18 PE PE2008002124A patent/PE20091522A1/es not_active Application Discontinuation
- 2008-12-18 AR ARP080105520A patent/AR069799A1/es unknown
- 2008-12-19 CA CA2709909A patent/CA2709909A1/en not_active Abandoned
- 2008-12-19 JP JP2010538767A patent/JP5525453B2/ja not_active Expired - Fee Related
- 2008-12-19 BR BRPI0820839-5A patent/BRPI0820839A2/pt not_active IP Right Cessation
- 2008-12-19 MY MYPI2010002374A patent/MY158293A/en unknown
- 2008-12-19 KR KR1020107016148A patent/KR20100103625A/ko not_active Application Discontinuation
- 2008-12-19 EP EP08865096A patent/EP2240164A2/en not_active Withdrawn
- 2008-12-19 US US12/808,905 patent/US20100316713A1/en not_active Abandoned
- 2008-12-19 WO PCT/EP2008/068051 patent/WO2009080762A2/en active Application Filing
- 2008-12-19 NZ NZ586313A patent/NZ586313A/xx not_active IP Right Cessation
- 2008-12-19 RU RU2010129544/15A patent/RU2485951C2/ru not_active IP Right Cessation
- 2008-12-19 TW TW097149851A patent/TWI449541B/zh not_active IP Right Cessation
- 2008-12-19 AU AU2008340019A patent/AU2008340019B2/en not_active Ceased
- 2008-12-19 CN CN2008801190561A patent/CN101883558A/zh active Pending
- 2008-12-19 CL CL2008003823A patent/CL2008003823A1/es unknown
-
2010
- 2010-05-24 IL IL205931A patent/IL205931A0/en unknown
- 2010-05-28 TN TN2010000243A patent/TN2010000243A1/fr unknown
- 2010-06-29 MA MA32969A patent/MA31950B1/fr unknown
- 2010-07-20 EC EC2010010360A patent/ECSP10010360A/es unknown
- 2010-07-21 CO CO10088697A patent/CO6382170A2/es not_active Application Discontinuation
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2013
- 2013-11-15 JP JP2013236787A patent/JP2014040477A/ja active Pending
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Also Published As
Publication number | Publication date |
---|---|
AU2008340019A1 (en) | 2009-07-02 |
RU2485951C2 (ru) | 2013-06-27 |
WO2009080762A2 (en) | 2009-07-02 |
WO2009080762A3 (en) | 2009-09-11 |
TW200940106A (en) | 2009-10-01 |
CA2709909A1 (en) | 2009-07-02 |
BRPI0820839A2 (pt) | 2015-06-16 |
JP5525453B2 (ja) | 2014-06-18 |
RU2010129544A (ru) | 2012-01-27 |
TWI449541B (zh) | 2014-08-21 |
IL205931A0 (en) | 2010-11-30 |
MA31950B1 (fr) | 2010-12-01 |
MY158293A (en) | 2016-09-30 |
PE20091522A1 (es) | 2009-10-29 |
US20100316713A1 (en) | 2010-12-16 |
AU2008340019B2 (en) | 2012-05-03 |
CL2008003823A1 (es) | 2010-01-22 |
KR20100103625A (ko) | 2010-09-27 |
CO6382170A2 (es) | 2012-02-15 |
NZ586313A (en) | 2012-08-31 |
JP2011506576A (ja) | 2011-03-03 |
EP2240164A2 (en) | 2010-10-20 |
TN2010000243A1 (en) | 2011-11-11 |
ECSP10010360A (es) | 2010-08-31 |
AR069799A1 (es) | 2010-02-17 |
CN101883558A (zh) | 2010-11-10 |
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