KR20090123964A - 다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 - Google Patents
다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 Download PDFInfo
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Abstract
Description
Claims (25)
- 다파글리플로진 프로필렌 글리콜 수화물 및 제약상 허용되는 담체를 포함하며, 다파글리플로진 프로필렌 글리콜 수화물 제형은 정제, 스톡 과립 및 캡슐로 구성된 군에서 선택된 형태이고, 다파글리플로진 프로필렌 글리콜 수화물은 1회 내지 4회 투여되는 단일 또는 분할 용량 또는 다중 용량으로 1일당 약 0.1 내지 약 750 mg 범위 내의 1일 용량을 제공하는 양으로 존재하는 것인, 즉시방출형 제약 제형.
- 제1항에 있어서,a) 다파글리플로진 프로필렌 글리콜 수화물;b) 1종 이상의 증량제;c) 임의로 1종 이상의 결합제;d) 임의로 1종 이상의 붕해제;e) 임의로 1종 이상의 활택제 및/또는 부착방지제; 및f) 임의로 1종 이상의 윤활제를 포함하는, 캡슐내의 로딩 또는 정제의 형성을 위한 스톡 과립 형태의 제형.
- 제3항에 있어서,a) 다파글리플로진 프로필렌 글리콜 수화물이 정제 또는 캡슐 충전량의 0.1 내지 30 중량%이고;b) 증량제가 정제 또는 캡슐 충전량의 약 1 내지 약 95 중량% 범위 내의 양으로 존재하고;c) 결합제가 정제 또는 캡슐 충전량의 약 0 내지 약 20 중량% 범위 내의 양으로 존재하고;d) 붕해제가 정제 또는 캡슐 충전량의 약 0 내지 약 20 중량% 범위 내의 양으로 존재하고;e) 활택제 및/또는 부착방지제가 정제 또는 캡슐 충전량의 약 0 내지 약 20 중량% 범위 내의 양으로 존재하고;f) 윤활제가 정제 또는 캡슐 충전량의 약 0 내지 약 5 중량% 범위 내의 양으로 존재하는 것인 제형.
- 제3항에 있어서,a) 정제 또는 캡슐 충전량의 약 0.1 내지 약 30 중량% 범위 내의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 증량제의 총량이 정제 또는 캡슐 충전량의 약 10 내지 약 85 중량% 범위 내의 양으로 존재하고, 락토스가 정제 또는 캡슐 충전량의 약 20 내지 약 75 중량% 범위 내의 양으로 존재하고, 미세결정질 셀룰로스가 정제 또는 캡슐 충전량의 약 20 내지 약 75 중량% 범위 내의 양으로 존재하는 것인, 락토스 및 미세결정질 셀룰로스를 포함하는 증량제,c) 전젤라틴화 전분이 정제 또는 캡슐 충전량의 약 10 내지 약 75 중량% 범위 내의 양으로 존재하는 것인, 전젤라틴화 전분을 포함하는 결합제,d) 붕해제의 총량이 정제 또는 캡슐 충전량의 약 0.25 내지 약 10 중량% 범위 내의 양으로 존재하고, 크로스카르멜로스 나트륨이 정제 또는 캡슐 충전량의 약 2 내지 약 10 중량% 범위 내의 양으로 존재하고, 크로스포비돈이 정제 또는 캡슐 충전량의 약 4 내지 약 10 중량% 범위 내의 양으로 존재하고, 나트륨 전분 글리콜레이트가 정제 또는 캡슐 충전량의 약 2 내지 약 10 중량% 범위 내의 양으로 존재하는 것인, 크로스카르멜로스 나트륨, 크로스포비돈 및 나트륨 전분 글리콜레이트를 포함하는 붕해제,e) 활택제 및/또는 부착방지제의 총량이 정제 또는 캡슐 충전량의 약 1 내지 약 10 중량% 범위 내의 양으로 존재하는 것인, 탈크 및/또는 이산화규소를 포함하는 1종 이상의 활택제 및/또는 부착방지제;f) 스테아르산마그네슘이 정제 또는 캡슐 충전량의 약 0.2 내지 약 2 중량% 범위 내의 양으로 존재하는 것인, 스테아르산마그네슘을 포함하는 윤활제를 포함하고;g) 외부 보호 코팅층의 총량이 정제 또는 캡슐 충전량의 약 1 내지 약 5 중량% 범위 내의 양으로 존재하는 것인, 코팅 중합체를 포함하고 가소제(들), 점착방지제(들), 활택제(들) 및 착색제(들) 중 1종 이상을 임의로 포함하는 외부 보호 코팅층을 임의로 추가로 포함하는 제형.
- 제3항에 있어서,a) 캡슐 충전량의 10 중량%의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 캡슐 충전량의 68.75 중량%의 양으로 존재하는 미세결정질 셀룰로스;c) 캡슐 충전량의 15 중량%의 양으로 존재하는 전젤라틴화 전분;d) 캡슐 충전량의 3 중량%의 양으로 존재하는 나트륨 전분 글리콜레이트;e) 캡슐 충전량의 2 중량%의 양으로 존재하는 이산화규소; 및f) 캡슐 충전량의 1.25 중량%의 양으로 존재하는 스테아르산마그네슘을 포함하는 2.5 mg 및 10 mg 스톡 과립으로 구성된 군에서 선택된 스톡 과립으로 충전된 캡슐 형태의 제형.
- 제3항에 있어서,a) 캡슐 충전량의 22.8 중량%의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 캡슐 충전량의 55.95 중량%의 양으로 존재하는 미세결정질 셀룰로스;c) 캡슐 충전량의 15 중량%의 양으로 존재하는 전젤라틴화 전분;d) 캡슐 충전량의 3 중량%의 양으로 존재하는 나트륨 전분 글리콜레이트;e) 캡슐 충전량의 2 중량%의 양으로 존재하는 이산화규소; 및f) 캡슐 충전량의 1.25 중량%의 양으로 존재하는 스테아르산마그네슘을 포함하는 100 mg 스톡 과립으로 충전된 캡슐 형태의 제형.
- 제3항에 있어서,a) 3.08 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 67.11 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 25 mg의 양으로 존재하는 무수 락토스;d) 8.75 mg의 양으로 존재하는 크로스포비돈;e) 3.75 mg의 양으로 존재하는 크로스카르멜로스 나트륨;f) 12.5 mg의 양으로 존재하는 탈크;g) 2.88 mg의 양으로 존재하는 이산화규소; 및h) 1.94 mg의 양으로 존재하는 스테아르산마그네슘을 포함하는 2.5 mg 정제 형태의 제형.
- 제3항에 있어서,a) 12.3 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 57.89 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 25 mg의 양으로 존재하는 무수 락토스;d) 8.75 mg의 양으로 존재하는 크로스포비돈;e) 3.75 mg의 양으로 존재하는 크로스카르멜로스 나트륨;f) 12.5 mg의 양으로 존재하는 탈크;g) 2.88 mg의 양으로 존재하는 이산화규소; 및h) 1.94 mg의 양으로 존재하는 스테아르산마그네슘을 포함하는 10 mg 정제 형태의 제형.
- 제3항에 있어서,a) 61.66 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 114.09 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 62.6 mg의 양으로 존재하는 무수 락토스;d) 21.91 mg의 양으로 존재하는 크로스포비돈;e) 9.39 mg의 양으로 존재하는 크로스카르멜로스 나트륨;f) 31.3 mg의 양으로 존재하는 탈크;g) 7.2 mg의 양으로 존재하는 이산화규소; 및h) 4.85 mg의 양으로 존재하는 스테아르산마그네슘을 포함하는 50 mg 정제 형태의 제형.
- 제3항에 있어서,a) 정제 또는 캡슐 충전량의 약 0.1 내지 약 15 중량% 범위 내의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 정제 또는 캡슐 충전량의 총량을 100%로 만들기에 충분한 양으로 존재하는 미세결정질 셀룰로스;c) 정제 또는 캡슐 충전량의 약 10 내지 약 30 중량% 범위 내의 양으로 존재하는 락토스;d) 정제 또는 캡슐 충전량의 약 3 내지 약 10 중량% 범위 내의 양으로 존재하는 크로스포비돈;e) 정제 또는 캡슐 충전량의 약 0.5 내지 약 4 중량% 범위 내의 양으로 존재하는 이산화규소; 및f) 정제 또는 캡슐 충전량의 약 0.5 내지 약 2 중량% 범위 내의 양으로 존재하는 스테아르산마그네슘을 포함하는 제형.
- 제3항에 있어서,a) 1.23 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 약 50 mg 내지 약 90 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 약 10 mg 내지 약 30 mg의 양으로 존재하는 락토스;d) 약 2 mg 내지 약 10 mg의 양으로 존재하는 크로스포비돈;e) 약 0.5 mg 내지 약 4.0 mg의 양으로 존재하는 이산화규소;f) 약 0.5 mg 내지 약 2.0 mg의 양으로 존재하는 스테아르산마그네슘; 및g) 약 0 mg 내지 약 0.5 mg의 양으로 존재하는 항산화제 및/또는 킬레이트제를 포함하는 1.0 mg 정제 형태의 제형.
- 제3항에 있어서,a) 3.075 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 약 60 mg 내지 약 115 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 약 12.5 mg 내지 약 38 mg의 양으로 존재하는 락토스;d) 약 2.5 mg 내지 약 13 mg의 양으로 존재하는 크로스포비돈;e) 약 0.6 mg 내지 약 5.0 mg의 양으로 존재하는 이산화규소;f) 약 0.6 mg 내지 약 2.5 mg의 양으로 존재하는 스테아르산마그네슘; 및g) 약 0 mg 내지 약 0.6 mg의 양으로 존재하는 항산화제 및/또는 킬레이트제를 포함하는 2.5 mg 정제 형태의 제형.
- 제3항에 있어서,a) 6.15 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 약 60 mg 내지 약 115 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 약 12.5 mg 내지 약 38 mg의 양으로 존재하는 락토스;d) 약 2.5 mg 내지 약 13 mg의 양으로 존재하는 크로스포비돈;e) 약 0.6 mg 내지 약 5.0 mg의 양으로 존재하는 이산화규소;f) 약 0.6 mg 내지 약 2.5 mg의 양으로 존재하는 스테아르산마그네슘; 및g) 약 0 mg 내지 약 0.6 mg의 양으로 존재하는 항산화제 및/또는 킬레이트제를 포함하는 5.0 mg 정제 형태의 제형.
- 제3항에 있어서,a) 12.3 mg의 양으로 존재하는 다파글리플로진 프로필렌 글리콜 수화물;b) 약 120 mg 내지 약 230 mg의 양으로 존재하는 미세결정질 셀룰로스;c) 약 25 mg 내지 약 75 mg의 양으로 존재하는 락토스;d) 약 5 mg 내지 약 25 mg의 양으로 존재하는 크로스포비돈;e) 약 1.0 mg 내지 약 10 mg의 양으로 존재하는 이산화규소;f) 약 1.0 mg 내지 약 5 mg의 양으로 존재하는 스테아르산마그네슘; 및g) 약 0 mg 내지 약 1.25 mg의 양으로 존재하는 항산화제 및/또는 킬레이트제를 포함하는 10 mg 정제 형태의 제형.
- I형 및 II형 당뇨병, 내당력 손상, 인슐린 저항성, 신장병증, 망막병증, 신경병증, 백내장, 고혈당증, 고인슐린혈증, 고콜레스테롤혈증, 이상지질혈증, 유리 지방산 또는 글리세롤의 혈중 수준 상승, 고지질혈증, 고중성지방혈증, 비만, 창상 치유, 조직 허혈, 죽상동맥경화증, 고혈압 또는 X 증후군 (대사성 증후군)의 진행 또는 발병의 치료 또는 지연을 위한 의약 제조에서의 제1항의 제약 제형의 용도.
- II형 당뇨병의 진행 또는 발병의 치료 또는 지연을 위한 의약 제조에서의 제1항의 제약 제형의 용도.
- II형 당뇨병의 진행 또는 발병의 치료 또는 지연의 요법에서 사용하기 위한 제1항의 제약 제형.
- 치료가 임의의 순서로 동시 또는 순차적 사용을 위한, 항당뇨제, 항고혈당제, 지질저하제 또는 지질강하제, 항비만제, 항고혈압제 및 식욕 억제제로 구성된 군에서 선택된 1종 이상의 약제와의 조합을 포함하는 것인, I형 및 II형 당뇨병, 내당력 손상, 인슐린 저항성, 신장병증, 망막병증, 신경병증, 백내장, 고혈당증, 고인슐린혈증, 고콜레스테롤혈증, 이상지질혈증, 유리 지방산 또는 글리세롤의 혈중 수준 상승, 고지질혈증, 고중성지방혈증, 비만, 창상 치유, 조직 허혈, 죽상동맥경화증, 고혈압 또는 X 증후군 (대사성 증후군)의 진행 또는 발병의 치료 또는 지연을 위한 의약 제조에서의 제1항의 제약 제형의 용도.
- 치료가 임의의 순서로 동시 또는 순차적 사용을 위한, 항당뇨제, 항고혈당 제, 지질저하제 또는 지질강하제, 항비만제, 항고혈압제 및 식욕 억제제로 구성된 군에서 선택된 1종 이상의 약제와의 조합을 포함하는 것인, II형 당뇨병의 진행 또는 발병의 치료 또는 지연을 위한 의약 제조에서의 제1항의 제약 제형의 용도.
- 치료가 임의의 순서로 동시 또는 순차적 사용을 위한, 1종 이상의 항당뇨제와의 조합을 포함하는 것인, II형 당뇨병의 진행 또는 발병의 치료 또는 지연을 위한 의약 제조에서의 제2항의 제약 제형의 용도.
- I형 및 II형 당뇨병, 내당력 손상, 인슐린 저항성, 신장병증, 망막병증, 신경병증, 백내장, 고혈당증, 고인슐린혈증, 고콜레스테롤혈증, 이상지질혈증, 유리 지방산 또는 글리세롤의 혈중 수준 상승, 고지질혈증, 고중성지방혈증, 비만, 창상 치유, 조직 허혈, 죽상동맥경화증, 고혈압 또는 X 증후군 (대사성 증후군)의 치료를 위한 의약으로서, 제1항의 제약 제형과 항당뇨제, 항고혈당제, 지질저하제 또는 지질강하제, 항비만제, 항고혈압제 및 식욕 억제제로 구성된 군에서 선택된 1종 이상의 약제의 조합물의 용도.
- 제22항에 있어서, 약제가 1종 이상의 항당뇨제(들)인 용도.
- II형 당뇨병의 치료를 위한 의약으로서, 제1항의 제약 제형과 항당뇨제, 항고혈당제, 지질저하제 또는 지질강하제, 항비만제, 항고혈압제 및 식욕 억제제로 구성된 군에서 선택된 1종 이상의 약제의 조합물의 용도.
- II형 당뇨병의 치료를 위한 의약으로서, 제2항의 제약 제형과 1종 이상의 항당뇨제의 조합물의 용도.
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KR20130132575A (ko) * | 2011-01-05 | 2013-12-04 | 렉시컨 파마슈티컬스 인코퍼레이티드 | 나트륨-글루코스 공동수송체 1 및 2의 억제제를 포함하는 조성물, 및 그를 사용하는 방법 |
WO2016018024A1 (ko) * | 2014-07-28 | 2016-02-04 | 한미정밀화학주식회사 | 다파글리프로진을 포함하는 결정질 복합체 및 이의 제조방법 |
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G170 | Re-publication after modification of scope of protection [patent] |