JP5591828B2 - 非ステロイド系抗炎症薬およびコルチコシド誘導体を含有する有効成分の新規な組み合わせ - Google Patents
非ステロイド系抗炎症薬およびコルチコシド誘導体を含有する有効成分の新規な組み合わせ Download PDFInfo
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- JP5591828B2 JP5591828B2 JP2011547060A JP2011547060A JP5591828B2 JP 5591828 B2 JP5591828 B2 JP 5591828B2 JP 2011547060 A JP2011547060 A JP 2011547060A JP 2011547060 A JP2011547060 A JP 2011547060A JP 5591828 B2 JP5591828 B2 JP 5591828B2
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- ketoprofen
- thiocorticoside
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Description
a)ケトプロフェンおよび医薬的に許容される賦形剤をブレンドしてブレンドされた材料を形成する工程、
b)バインダー材料を医薬的に許容される賦形剤と共に調製する工程、
c)バインダー材料をケトプロフェンを含有する調製物に添加する工程、
d)c)から得られた材料を湿式造粒する工程、
e)湿式サイジング工程、
f)乾燥工程、
g)乾燥サイジング工程、
h)チオコルチコシドおよび医薬的に許容される賦形剤をブレンドして、ブレンドされた材料を形成し、すべての材料を1mmシーブにシーブする工程、
i)工程g)およびh)からの材料をブレンドする工程、
j)潤滑剤を添加する工程であって、すべての材料を1mmシーブにシーブすることを含む工程、
k)錠剤剤形を形成するための錠剤化工程
を含む、錠剤剤形を製造する方法である。
工程1:医薬賦形剤と共にケトプロフェンを選別し、混合した。
工程2:バインダー溶液を調製し、工程1の材料を造粒し、均一な顆粒を得た。湿潤顆粒を乾燥させ、圧縮に必要な最適湿分を達成させた。
工程3:乾燥した顆粒を選別し、医薬賦形剤と共にチオコルチコシドを添加し、混合した。
工程4:ステアリン酸マグネシウムを選別し、混合した。
工程5:好適な工具を用いてブレンドを圧縮して錠剤にし、コーティング材料を用いてコーティングした。
工程2:内容物を圧縮/スラッグし、シーブした。
工程3:チオコルチコシドおよび他の医薬賦形剤を選別し、混合した。
工程4:ステアリン酸マグネシウムを選別し、混合した。
工程5:ブレンドを錠剤に圧縮して、コーティング材料を用いてコーティングした。
B欄:顆粒外造粒を経て調製されたケトプロフェンおよびチオコルチコシドを含有する初期時間におけるロット2
C欄:40℃/湿度割合75%RHにて2カ月後、組み合わせ造粒により調製されたケトプロフェンおよびチオコルチコシドを含有するロット1。不純物データは、2Mステーションでの40℃/湿度割合75%RHを示す表にする。
D欄:40℃/湿度割合75%RHにて6カ月後、顆粒外造粒により調製されたケトプロフェンおよびチオコルチコシドを含有するロット2。安定性データは、ロット1において(A欄対C欄)、パッケージされたサンプル中で40℃/湿度割合75%RHでは2カ月以内に不純物のレベルが大幅に増大することを示している。安定性データは、ロット2において(B欄対D欄)、パッケージされたサンプル中で40℃/湿度割合75%RHでは6カ月後でさえも不純物に顕著な変化は認められないことを示している。上記データから、ケトプロフェンおよびチオコルチコシドを剤形内で密接に混合していない場合、顕著な相互作用はなく、不純物は実質的に低いレベルであることが推測される。
本発明に記載の組成物は、安全であり、急性LBPに有効であると考えることができる。
Claims (11)
- 有効成分として、顆粒ケトプロフェンおよび顆粒チオコルチコシドの組み合わせを含有する錠剤の形態での医薬組成物であって、有効成分が、遊離状態または塩の形態において存在し、ケトプロフェンおよびチオコルチコシドは、錠剤における組み合わせの前に、別々に顆粒化される、医薬組成物。
- 経口経路によって投与できる形態の、請求項1に記載の医薬組成物。
- フィルムコーティングされた錠剤の形態である、請求項1または2に記載の医薬組成物。
- 100mgのケトプロフェンおよび8mgのチオコルチコシドを含有し、分割可能な固体剤形の形態である、請求項1から3のいずれか一項に記載の医薬組成物。
- 50から100mgのケトプロフェンおよび4から8mgのチオコルチコシドを含有する、請求項1から4のいずれか一項に記載の医薬組成物。
- 100mgのケトプロフェンおよび8mgのチオコルチコシドを含有する、請求項5に記載の医薬組成物。
- 50mgのケトプロフェンおよび4mgのチオコルチコシドを含有する、請求項5に記載の医薬組成物。
- 筋骨格障害および関節障害を処置および/または寛解するための、請求項1から7のいずれか一項に記載の医薬組成物。
- 筋骨格障害および関節障害を寛解および/または処置することを目的とする薬剤の調製のための、請求項1から8のいずれか一項に記載の医薬組成物。
- a)ケトプロフェンおよび医薬的に許容される賦形剤をブレンドしてブレンドされた材料を形成する工程、
b)バインダー材料を医薬的に許容される賦形剤と共に調製する工程、
c)バインダー材料をケトプロフェンを含有する調製物に添加する工程、
d)c)から得られた材料を湿式造粒する工程、
e)湿式サイジング工程、
f)乾燥工程、
g)乾燥サイジング工程、
h)チオコルチコシドおよび医薬的に許容される賦形剤をブレンドして、ブレンドされた材料を形成し、すべての材料を1mmシーブにシーブする工程、
i)工程g)およびh)からの材料をブレンドする工程、
j)潤滑剤を添加する工程であって、すべての材料を1mmシーブにシーブすることを含む工程、
k)錠剤剤形を形成するための錠剤化工程
を含む、請求項1の錠剤剤形を製造する方法。 - 請求項10に記載の錠剤剤形を製造する工程、および加熱工程の後、フィルムコーティングされた錠剤剤形を形成するためのコーティング工程を含む、フィルムコーティングされた錠剤剤形を製造する方法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/IN2009/000071 WO2010084500A1 (en) | 2009-01-22 | 2009-01-22 | New combination of active ingredients containing a non steroidal anti inflammatory drug and a colchicoside derivative |
Publications (2)
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JP2012515764A JP2012515764A (ja) | 2012-07-12 |
JP5591828B2 true JP5591828B2 (ja) | 2014-09-17 |
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JP2011547060A Expired - Fee Related JP5591828B2 (ja) | 2009-01-22 | 2009-01-22 | 非ステロイド系抗炎症薬およびコルチコシド誘導体を含有する有効成分の新規な組み合わせ |
Country Status (21)
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US (1) | US20120052121A1 (ja) |
EP (1) | EP2389173A1 (ja) |
JP (1) | JP5591828B2 (ja) |
CN (1) | CN102665705A (ja) |
AR (1) | AR074521A1 (ja) |
AU (1) | AU2009338480A1 (ja) |
BR (1) | BRPI0924198A2 (ja) |
CA (1) | CA2750457A1 (ja) |
EA (1) | EA201170950A1 (ja) |
EC (1) | ECSP11011212A (ja) |
IL (1) | IL214134A0 (ja) |
MA (1) | MA33055B1 (ja) |
MX (1) | MX2011007814A (ja) |
PE (1) | PE20100560A1 (ja) |
SG (1) | SG173071A1 (ja) |
TN (1) | TN2011000352A1 (ja) |
TW (1) | TWI424850B (ja) |
UA (1) | UA102010C2 (ja) |
UY (1) | UY31856A (ja) |
WO (1) | WO2010084500A1 (ja) |
ZA (1) | ZA201105386B (ja) |
Families Citing this family (2)
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WO2012173581A1 (en) | 2011-03-21 | 2012-12-20 | Ak Kimya Ithalat-Ihracat Ve Sanayii A.S. | Thiocolchicoside, etodolac and famotidine combinations |
TR201103752A2 (tr) | 2011-04-18 | 2012-11-21 | Ak Ki̇mya İthalat-İhracat Ve Sanayi̇i̇ A.Ş. | Tiyokolşikozit, diklofenak ve lansoprazol kombinasyonları. |
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FR2929M (fr) * | 1963-04-11 | 1964-11-16 | S O M A I N Soc De Marques Et | Composition pharmaceutique pour le traitement des affections arthritiques et rhumatismales. |
US4780463A (en) * | 1984-12-26 | 1988-10-25 | Analgesic Associates | Analgesic, anti-inflammatory and skeletal muscle relaxant compositions comprising non-steroidal anti-inflammatory drugs and musculoskeletal relaxants and methods of using same |
FR2725134B1 (fr) * | 1994-10-04 | 1996-12-20 | Lederle Lab | Nouvelle association pharmaceutique a base d'ibuprofene et de thiocolchicoside |
FR2735369B1 (fr) * | 1995-06-13 | 1997-07-11 | Synthelabo | Compositions pharmaceutiques a base de sel de sodium du diclofenac et de thiocolchicoside |
US6235311B1 (en) * | 1998-03-18 | 2001-05-22 | Bristol-Myers Squibb Company | Pharmaceutical composition containing a combination of a statin and aspirin and method |
US6197347B1 (en) * | 1998-06-29 | 2001-03-06 | Andrx Pharmaceuticals, Inc. | Oral dosage for the controlled release of analgesic |
KR20150001844A (ko) * | 2006-01-24 | 2015-01-06 | 넥스바이오, 인코퍼레이티드 | 고분자 미소 구체들의 조제를 위한 기술 |
TR200703092A1 (tr) * | 2007-05-08 | 2008-12-22 | SANOVEL �LA� SAN. VE TiC. A.�. | Flurbiprofen ve kas gevşetici kombinasyonları |
RU2493832C2 (ru) * | 2008-01-25 | 2013-09-27 | Дюо-Же | Комбинации пероральных лекарственных средств, соединенных посредством оболочки |
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- 2009-01-22 JP JP2011547060A patent/JP5591828B2/ja not_active Expired - Fee Related
- 2009-01-22 BR BRPI0924198A patent/BRPI0924198A2/pt not_active IP Right Cessation
- 2009-01-22 EA EA201170950A patent/EA201170950A1/ru unknown
- 2009-01-22 MX MX2011007814A patent/MX2011007814A/es not_active Application Discontinuation
- 2009-01-22 MA MA34108A patent/MA33055B1/fr unknown
- 2009-01-22 EP EP09787570A patent/EP2389173A1/en not_active Withdrawn
- 2009-01-22 CA CA2750457A patent/CA2750457A1/en not_active Abandoned
- 2009-01-22 CN CN200980157754.5A patent/CN102665705A/zh active Pending
- 2009-01-22 SG SG2011052529A patent/SG173071A1/en unknown
- 2009-01-22 UA UAA201110223A patent/UA102010C2/ru unknown
- 2009-01-22 WO PCT/IN2009/000071 patent/WO2010084500A1/en active Application Filing
- 2009-01-22 AU AU2009338480A patent/AU2009338480A1/en not_active Abandoned
- 2009-05-27 TW TW098117879A patent/TWI424850B/zh not_active IP Right Cessation
- 2009-05-28 AR ARP090101903A patent/AR074521A1/es not_active Application Discontinuation
- 2009-05-28 PE PE2009000748A patent/PE20100560A1/es not_active Application Discontinuation
- 2009-05-29 UY UY0001031856A patent/UY31856A/es not_active Application Discontinuation
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2011
- 2011-07-15 TN TN2011000352A patent/TN2011000352A1/fr unknown
- 2011-07-18 EC EC2011011212A patent/ECSP11011212A/es unknown
- 2011-07-18 IL IL214134A patent/IL214134A0/en unknown
- 2011-07-21 ZA ZA2011/05386A patent/ZA201105386B/en unknown
- 2011-07-22 US US13/188,772 patent/US20120052121A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
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AR074521A1 (es) | 2011-01-26 |
UA102010C2 (ru) | 2013-05-27 |
CN102665705A (zh) | 2012-09-12 |
PE20100560A1 (es) | 2010-08-16 |
TW201028155A (en) | 2010-08-01 |
SG173071A1 (en) | 2011-08-29 |
AU2009338480A1 (en) | 2011-08-11 |
US20120052121A1 (en) | 2012-03-01 |
JP2012515764A (ja) | 2012-07-12 |
TWI424850B (zh) | 2014-02-01 |
WO2010084500A1 (en) | 2010-07-29 |
CA2750457A1 (en) | 2010-07-29 |
MX2011007814A (es) | 2011-11-29 |
EA201170950A1 (ru) | 2012-02-28 |
EP2389173A1 (en) | 2011-11-30 |
ZA201105386B (en) | 2012-09-26 |
TN2011000352A1 (en) | 2013-03-27 |
ECSP11011212A (es) | 2011-08-31 |
MA33055B1 (fr) | 2012-02-01 |
UY31856A (es) | 2010-08-31 |
BRPI0924198A2 (pt) | 2016-02-16 |
IL214134A0 (en) | 2011-08-31 |
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