KR20180090966A - 몬테루카스트 또는 이의 약학적으로 허용가능한 염 및 레보세티리진 또는 이의 약학적으로 허용가능한 염을 함유하는 캡슐 제제 - Google Patents
몬테루카스트 또는 이의 약학적으로 허용가능한 염 및 레보세티리진 또는 이의 약학적으로 허용가능한 염을 함유하는 캡슐 제제 Download PDFInfo
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Abstract
본 발명에 따른 캡슐 제제는 상기 두 활성성분을 완전히 분리할 수 있어 약리 활성성분간의 반응성이 최소화되기 때문에 경시변화에 따른 제품 안정성이 우수하여 치료 효과를 극대화할 수 있다.
Description
시간(분) | A(%) | B(%) |
0 | 60 | 40 |
20 | 10 | 90 |
30 | 10 | 90 |
31 | 60 | 40 |
35 | 60 | 40 |
시간(분) | A(%) | B(%) |
0 | 100 | 0 |
2 | 100 | 0 |
30 | 25 | 75 |
40 | 100 | 0 |
50 | 100 | 0 |
성분 | 제제 | 초기 | 1개월 | 2개월 | 4개월 | 6개월 |
몬테루카스트 |
실시예 1 | 100.0 % | 99.9 % | 99.7 % | 99.7 % | 99.6 % |
실시예 5 | 100.0 % | 100.0 % | 99.9 % | 99.6 % | 99.4 % | |
실시예 6 | 100.0 % | 99.8 % | 99.5 % | 99.4 % | 99.2 % | |
실시예 7 | 100.0 % | 99.8 % | 99.7 % | 99.5 % | 99.3 % | |
비교예 1 | 100.0 % | 99.0 % | 97.6 % | 96.4 % | 93.6 % | |
비교예 2 | 100.0 % | 98.5 % | 96.3 % | 95.4 % | 92.3 % | |
레보세티리진 |
실시예 1 | 100.0 % | 99.5 % | 99.4 % | 99.3 % | 99.2 % |
실시예 5 | 100.0 % | 99.8 % | 99.6 % | 99.4 % | 99.3 % | |
실시예6 | 100.0 % | 99.7 % | 99.6 % | 99.3 % | 98.9 % | |
실시예7 | 100.0 % | 99.6 % | 99.5 % | 99.4 % | 99.2 % | |
비교예1 | 100.0 % | 98.4 % | 95.9 % | 94.4 % | 91.5 % | |
비교예2 | 100.0 % | 98.1 % | 94.4 % | 93.6 % | 92.7 % |
시료 | 초기 | 가속 6개월 | ||||
몬테 술폭사이드 (%) |
몬테 시스-이성체 (%) |
유연물질 총합 (%) |
몬테 술폭사이드 (%) |
몬테 시스-이성체 (%) |
유연물질 총합 (%) |
|
실시예 1 | 01 | 02 | 03 | 09 | 03 | 15 |
실시예 5 | 0.02 | 0.01 | 0.05 | 0.07 | 0.05 | 0.14 |
실시예 6 | 0.01 | 0.03 | 0.04 | 0.08 | 0.09 | 0.21 |
실시예 7 | 0.02 | 0.04 | 0.03 | 0.35 | 0.12 | 0.65 |
비교예 1 | 0.04 | 0.11 | 0.20 | 2.45 | 1.35 | 4.64 |
비교예 2 | 0.10 | 0.07 | 0.24 | 3.11 | 1.05 | 5.47 |
시료 |
초기 | 가속 6개월 | ||||||
유연물질 A (%) |
유연물질 B (%) |
유연물질 D (%) |
유연물질 총합(%) |
유연물질 A(%) |
유연물질 B (%) |
유연물질 D(%) |
유연물질 총합(%) |
|
실시예 1 | 02 | 01 | 01 | 06 | 12 | 11 | 02 | 35 |
실시예 5 | 0.02 | 0.01 | 0.00 | 0.05 | 0.09 | 0.11 | 0.02 | 0.42 |
실시예 6 | 0.01 | 0.02 | 0.01 | 0.06 | 0.08 | 0.05 | 0.03 | 0.29 |
실시예 7 | 0.03 | 0.06 | 0.02 | 0.12 | 0.35 | 0.38 | 0.02 | 0.85 |
비교예 1 | 0.05 | 0.07 | 0.20 | 0.35 | 1.12 | 1.08 | 3.45 | 5.95 |
비교예 2 | 0.04 | 0.05 | 0.15 | 0.33 | 1.11 | 1.04 | 3.05 | 6.42 |
Claims (18)
상기 몬테루카스트 독립층 및 레보세티리진 독립층은 정제의 형태이며,
상기 몬테루카스트 독립층 및 레보세티리진 독립층의 수분함량이 5% 이하인 것을 특징으로 하는, 알레르기성 비염 및 천식의 예방 또는 치료용 캡슐 제제.
상기 몬테루카스트 독립층 및 레보세티리진 독립층이 희석제, 붕해제, 결합제, 안정화제, 활택제, 색소 및 이들의 혼합물로 이루어진 군에서 선택되는 약학적으로 허용가능한 첨가제를 추가로 포함하는 것을 특징으로 하는, 캡슐 제제.
상기 몬테루카스트 독립층 및 레보세티리진 독립층이 물 또는 유기용매를 사용하지 않거나, 또는 물 또는 유기용매를 실질적으로 포함하지 않는 상태로 제조되는 것을 특징으로 하는, 캡슐 제제.
상기 정제가 코팅층을 추가로 포함하는 것을 특징으로 하는, 캡슐 제제.
상기 코팅층이 물 또는 유기용매를 사용하지 않거나, 또는 물 또는 유기용매를 실질적으로 포함하지 않는 수계 코팅으로 제조되는 것을 특징으로 하는, 캡슐 제제.
상기 코팅층에 사용가능한 코팅기제가 메틸셀룰로오스, 에틸셀룰로오스, 폴리비닐알콜, 폴리비닐피롤리돈, 히드록시에틸셀룰로오스, 히드록시프로필 메틸셀룰로오스 및 이의 혼합물로 이루어진 군에서 선택되는 것을 특징으로 하는, 캡슐 제제.
상기 코팅기제가 정제 총 중량을 기준으로 1 내지 20중량%의 양으로 사용되는 것을 특징으로 하는, 캡슐 제제.
상기 캡슐이 경질 캡슐인 것을 특징으로 하는, 캡슐 제제.
상기 캡슐의 기제가 히프로멜로오스, 풀루란, 젤라틴 및 폴리비닐 알콜로 이루어진 군으로부터 선택되는 것을 특징으로 하는, 캡슐 제제.
상기 캡슐의 기제가 히프로멜로오스 또는 풀루란인 것을 특징으로 하는, 캡슐 제제.
상기 몬테루카스트 또는 이의 약학적으로 허용가능한 염이 2.5 mg 내지 20 mg의 범위의 양으로 포함되는 것을 특징으로 하는, 캡슐 제제.
상기 레보세티리진 또는 이의 약학적으로 허용가능한 염이 2.5 mg 내지 20 mg의 범위의 양으로 포함되는 것을 특징으로 하는, 캡슐 제제.
상기 몬테루카스트의 약학적으로 허용가능한 염이 몬테루카스트 나트륨인 것을 특징으로 하는, 캡슐 제제.
상기 레보세티리진의 약학적으로 허용가능한 염이 레보세티리진 이염산염인 것을 특징으로 하는, 캡슐 제제.
상기 알레르기성 비염이 비루, 비폐색, 비소양증, 재채기 및 안구소양증의 증상을 포함하는 것을 특징으로 하는, 캡슐 제제.
ii) 레보세티리진 또는 이의 약학적으로 허용가능한 염, 및 약제학적 허용가능한 첨가제를 혼합 및 과립화하고, 상기 과립을 타정하여 정제화하는 단계; 및
iii) 상기 단계 i)에서 제조된 몬테루카스트 정제, 및 단계 ii)에서 제조된 레보세티리진 정제를 경질 캡슐에 분리된 독립층을 이루도록 충전하는 단계를 포함하고,
상기 몬테루카스트 독립층 및 레보세티리진 독립층의 수분함량이 5% 이하인 것을 특징으로 하는, 제 1 항에 따른 캡슐 제제의 제조 방법.
상기 단계 i) 또는 ii)에서 제조된 정제를 코팅하는 단계를 추가로 포함하는 것을 특징으로 하는 제조방법.
상기 단계 iii)에서, 몬테루카스트 정제 및 레보세티리진 정제를 경질 캡슐에 충전하여 분리된 독립층을 이루는 것을 특징으로 하는 제조방법.
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KR1020180088162A KR102006000B1 (ko) | 2011-07-15 | 2018-07-27 | 몬테루카스트 또는 이의 약학적으로 허용가능한 염 및 레보세티리진 또는 이의 약학적으로 허용가능한 염을 함유하는 캡슐 제제 |
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EP (1) | EP2731594B1 (ko) |
JP (1) | JP2014520842A (ko) |
KR (2) | KR20130009553A (ko) |
CN (2) | CN107468667A (ko) |
AR (1) | AR087177A1 (ko) |
BR (1) | BR112014000943A2 (ko) |
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JO (1) | JO3551B1 (ko) |
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PE (1) | PE20141200A1 (ko) |
RU (1) | RU2606857C2 (ko) |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20230057974A (ko) | 2021-10-21 | 2023-05-02 | 한화제약주식회사 | 몬테루카스트 또는 이의 약학적으로 허용가능한 염 및 레보세티리진 또는 이의 약학적으로 허용가능한 염을 함유하는 안정성이 개선된 필름코팅 정제 |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011159821A1 (en) | 2010-06-16 | 2011-12-22 | Bruce Chandler May | Use of levocetirizine and montelukast in the treatment of influenza, common cold and inflammation |
KR101418404B1 (ko) * | 2012-01-06 | 2014-07-10 | 한미약품 주식회사 | 레보세티리진 또는 이의 약학적으로 허용가능한 염 및 몬테루카스트 또는 이의 약학적으로 허용가능한 염을 함유하는 안정한 경구투여용 약학 제제 |
RU2677649C2 (ru) * | 2013-02-21 | 2019-01-18 | Глэнмарк Фармасьютикалс Лимитед | Фармацевтические композиции монтелукаста и левоцетиризина |
CA2901421A1 (en) | 2013-03-13 | 2014-10-09 | Bruce Chandler May | Use of levocetirizine and montelukast in the treatment of autoimmune disorders |
ES2709849T3 (es) * | 2013-03-13 | 2019-04-17 | Irr Inc | Uso de levocetirizina y montelukast en el tratamiento de anafilaxia |
KR20150135339A (ko) * | 2013-03-13 | 2015-12-02 | 인플래머토리 리스폰스 리서치, 아이엔씨. | 레보세티리진 및 몬테루카스트의 외상성 손상의 치료 용도 |
EP2968309A4 (en) | 2013-03-13 | 2016-08-31 | Inflammatory Response Res Inc | USE OF LEVOCETRIXIN AND MONTELUKAST IN THE TREATMENT OF VASCULARITY |
KR102226833B1 (ko) * | 2013-06-28 | 2021-03-12 | 한미약품 주식회사 | 레보세티리진 및 몬테루카스트를 포함하는 안정성이 개선된 복합 과립 제형 |
WO2015069203A1 (en) * | 2013-11-06 | 2015-05-14 | Santa Farma Ilaç Sanayi A.Ş. | Capsule comprising rupatadine fumarate and montelukast sodium |
KR101669556B1 (ko) * | 2014-07-02 | 2016-10-28 | 한미약품 주식회사 | 몬테루카스트 또는 이의 약제학적으로 허용가능한 염의 경구투여용 액상제제 |
JP6575031B2 (ja) * | 2014-07-28 | 2019-09-18 | 日本ケミファ株式会社 | モンテルカストナトリウム製剤 |
WO2016044095A1 (en) | 2014-09-15 | 2016-03-24 | Inflammatory Response Research, Inc. | Levocetirizine and montelukast in the treatment of inflammation mediated conditions |
PL3222279T3 (pl) | 2016-03-21 | 2022-05-09 | Invest Bielany Spółka Z Ograniczoną Odpowiedzialnością | Doustny preparat farmaceutyczny montelukastu i lewocetyryzyny oraz sposób jego wytwarzania |
JP7222911B2 (ja) | 2017-04-14 | 2023-02-15 | カプスゲル・ベルギウム・ナムローゼ・フェンノートシャップ | プルランを作製する方法 |
AU2018251256B2 (en) | 2017-04-14 | 2023-10-05 | Capsugel Belgium Nv | Pullulan capsules |
KR20210152280A (ko) | 2020-06-08 | 2021-12-15 | 주식회사 경보제약 | 몬테루카스트와 레보세티리진을 포함하는 안정성이 향상된 단일 정제 및 이의 제조방법 |
KR102481517B1 (ko) | 2021-08-30 | 2022-12-27 | 주식회사 클라시아 | 약제학적 제제 |
KR20240045586A (ko) | 2022-09-30 | 2024-04-08 | 주식회사 제뉴원사이언스 | 레보세티리진 또는 이의 약학적으로 허용가능한 염 및 몬테루카스트 또는 이의 약학적으로 허용가능한 염을 포함하는 안정성이 향상된 이층정 정제 및 그의 제조방법 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1994006429A1 (en) | 1992-09-24 | 1994-03-31 | Sepracor, Inc. | Compositions for treating allergic disorders using (-) cetirizine |
KR20090017423A (ko) * | 2007-08-13 | 2009-02-18 | 한올제약주식회사 | HMGCoA 환원효소 저해제와 아스피린을 포함하는 복합제제 및 그의 제조방법 |
KR100926410B1 (ko) | 2001-06-28 | 2009-11-12 | 유씨비 파쉼 소시에떼아노님 | 세티리진 및 슈도에페드린을 포함하는 정제 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2588188B1 (fr) * | 1985-10-04 | 1988-01-08 | Delalande Sa | Comprime de sel(s) hydrosoluble(s) de cinepazide a liberation programmee et son procede de preparation |
DE4101873C2 (de) * | 1991-01-23 | 1993-12-09 | Isis Pharma Gmbh | Peroral applizierbare Arzneiform zur Behandlung zentraler Dopaminmangelzustände |
RU2108787C1 (ru) * | 1993-09-01 | 1998-04-20 | Роммерс С.А.И.С.Ф. | Фармацевтические мягкие капсулы, содержащие лизинхлониксинат, способ их получения |
SK286103B6 (sk) * | 1997-12-23 | 2008-03-05 | Schering Corporation | Farmaceutický prostriedok na liečenie respiračných a kožných ochorení s obsahom aspoň jedného antagonistu leukotriénu a aspoň jedného antihistaminikaa jeho použitie |
IL159287A0 (en) * | 2001-06-28 | 2004-06-01 | Ucb Farchim Sa | Tablet comprising cetirizine and pseudoephedrine |
CA2559276A1 (en) * | 2004-03-11 | 2005-09-29 | John P. Mullally | Protocol for improving vision |
FR2898492B1 (fr) * | 2006-03-15 | 2008-06-06 | Pierre Fabre Medicament Sa | Comprimes orodispersibles de domperidone |
CN101073563B (zh) * | 2007-02-07 | 2010-10-06 | 西安利君制药有限责任公司 | 一种含有右旋布洛芬和左旋西替利嗪的手性组合物及其缓速释双层片 |
RU2405542C2 (ru) * | 2008-11-19 | 2010-12-10 | Закрытое акционерное общество "Санкт-Петербургский институт фармации" | Мягкая экструзионная капсула, способ приготовления раствора для ее наполнения, способ получения капсул и способ увеличения плотности агаровой оболочки |
WO2010107404A1 (en) * | 2009-03-16 | 2010-09-23 | Mahmut Bilgic | Stable pharmaceutical combinations |
-
2011
- 2011-10-28 KR KR1020110111132A patent/KR20130009553A/ko active Search and Examination
-
2012
- 2012-07-08 JO JOP/2012/0182A patent/JO3551B1/ar active
- 2012-07-11 MX MX2014000312A patent/MX366509B/es active IP Right Grant
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- 2012-07-11 CN CN201710839356.8A patent/CN107468667A/zh active Pending
- 2012-07-11 MY MYPI2014700043A patent/MY178890A/en unknown
- 2012-07-11 EP EP12814306.2A patent/EP2731594B1/en not_active Not-in-force
- 2012-07-11 US US14/232,433 patent/US20140170213A1/en not_active Abandoned
- 2012-07-11 BR BR112014000943A patent/BR112014000943A2/pt not_active Application Discontinuation
- 2012-07-11 RU RU2014105577A patent/RU2606857C2/ru not_active IP Right Cessation
- 2012-07-11 ES ES12814306T patent/ES2727861T3/es active Active
- 2012-07-11 WO PCT/KR2012/005506 patent/WO2013012199A1/en active Application Filing
- 2012-07-11 PE PE2014000056A patent/PE20141200A1/es not_active Application Discontinuation
- 2012-07-11 CN CN201280035070.XA patent/CN103687591A/zh active Pending
- 2012-07-13 AR ARP120102542A patent/AR087177A1/es not_active Application Discontinuation
- 2012-07-13 TW TW101125301A patent/TW201311241A/zh unknown
- 2012-07-14 SA SA112330689A patent/SA112330689B1/ar unknown
- 2012-11-07 UA UAA201401447A patent/UA112083C2/uk unknown
-
2014
- 2014-01-09 CL CL2014000054A patent/CL2014000054A1/es unknown
- 2014-02-11 CO CO14028388A patent/CO6880062A2/es unknown
- 2014-02-14 ZA ZA2014/01143A patent/ZA201401143B/en unknown
- 2014-08-29 HK HK18105848.3A patent/HK1246199A1/zh unknown
-
2015
- 2015-11-06 US US14/934,348 patent/US20160089339A1/en not_active Abandoned
-
2018
- 2018-07-27 KR KR1020180088162A patent/KR102006000B1/ko active IP Right Grant
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1994006429A1 (en) | 1992-09-24 | 1994-03-31 | Sepracor, Inc. | Compositions for treating allergic disorders using (-) cetirizine |
KR100926410B1 (ko) | 2001-06-28 | 2009-11-12 | 유씨비 파쉼 소시에떼아노님 | 세티리진 및 슈도에페드린을 포함하는 정제 |
KR20090017423A (ko) * | 2007-08-13 | 2009-02-18 | 한올제약주식회사 | HMGCoA 환원효소 저해제와 아스피린을 포함하는 복합제제 및 그의 제조방법 |
Non-Patent Citations (4)
Title |
---|
Journal of Indian Medical Association, 107(8), 2009.8., pp. 562-564* * |
M. M. Al Omari et al., J. Pharm. and Biomed. Anal., 45, 465-471 (2007) |
R. T. Rathod, J. Indian Med. Assoc., 107(8), 562-564 (2009) |
S. E. Dahlen, Eur. J. Pharmacol., 533(1-3), 40-56 (2006) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20230057974A (ko) | 2021-10-21 | 2023-05-02 | 한화제약주식회사 | 몬테루카스트 또는 이의 약학적으로 허용가능한 염 및 레보세티리진 또는 이의 약학적으로 허용가능한 염을 함유하는 안정성이 개선된 필름코팅 정제 |
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MY178890A (en) | 2020-10-21 |
RU2606857C2 (ru) | 2017-01-10 |
US20140170213A1 (en) | 2014-06-19 |
KR20130009553A (ko) | 2013-01-23 |
BR112014000943A2 (pt) | 2017-02-14 |
UA112083C2 (uk) | 2016-07-25 |
US20160089339A1 (en) | 2016-03-31 |
ZA201401143B (en) | 2015-04-29 |
RU2014105577A (ru) | 2015-08-27 |
EP2731594B1 (en) | 2019-04-24 |
MX366509B (es) | 2019-07-11 |
PE20141200A1 (es) | 2014-09-29 |
EP2731594A4 (en) | 2014-12-31 |
MX2014000312A (es) | 2014-02-19 |
TW201311241A (zh) | 2013-03-16 |
CL2014000054A1 (es) | 2014-07-11 |
HK1246199A1 (zh) | 2018-09-07 |
ES2727861T3 (es) | 2019-10-21 |
KR102006000B1 (ko) | 2019-08-01 |
WO2013012199A8 (en) | 2014-02-06 |
JO3551B1 (ar) | 2020-07-05 |
CO6880062A2 (es) | 2014-02-28 |
WO2013012199A1 (en) | 2013-01-24 |
CN107468667A (zh) | 2017-12-15 |
EP2731594A1 (en) | 2014-05-21 |
CN103687591A (zh) | 2014-03-26 |
JP2014520842A (ja) | 2014-08-25 |
SA112330689B1 (ar) | 2017-03-02 |
AR087177A1 (es) | 2014-02-26 |
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