KR20090009226A - Dpp iv 억제제 제형 - Google Patents
Dpp iv 억제제 제형 Download PDFInfo
- Publication number
- KR20090009226A KR20090009226A KR1020087026969A KR20087026969A KR20090009226A KR 20090009226 A KR20090009226 A KR 20090009226A KR 1020087026969 A KR1020087026969 A KR 1020087026969A KR 20087026969 A KR20087026969 A KR 20087026969A KR 20090009226 A KR20090009226 A KR 20090009226A
- Authority
- KR
- South Korea
- Prior art keywords
- pharmaceutical composition
- weight
- diluent
- lubricant
- disintegrant
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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Abstract
Description
Claims (20)
- 활성 성분으로서 아미노 그룹을 갖는 DPP IV(dipeptidyl peptidase IV) 억제제 화합물 또는 이의 염, 제1 희석제, 제2 희석제, 결합제, 붕해제 및 윤활제를 포함하는, 약제학적 조성물.
- 제1항에 있어서, 추가의 붕해제를 포함하는, 약제학적 조성물.
- 제1항 또는 제2항에 있어서, 추가의 활제를 포함하는, 약제학적 조성물.
- 제1항에 있어서, 희석제가 셀룰로오스 분말, 2염기성 인산칼슘 무수물, 2염기성 인산칼슘 2수화물, 에리트리톨, 저치환된 하이드록시프로필 셀룰로오스, 만니톨, 예비젤라틴화 전분 또는 자일리톨인, 약제학적 조성물.
- 제1항에 있어서, 윤활제가 활석, 폴리에틸렌글리콜, 베헨산칼슘, 스테아르산칼슘, 수소화 피마자유 또는 스테아르산마그네슘인, 약제학적 조성물.
- 제2항에 있어서, 결합제가 코포비돈(비닐피롤리돈의 기타 비닐유도체와의 공중합물), 하이드록시프로필 메틸셀룰로오스(HPMC), 하이드록시프로필셀룰로오스(HPC) 또는 폴리비닐피롤리돈(포비돈)인, 약제학적 조성물.
- 제1항에 있어서, 붕해제가 옥수수 전분인, 약제학적 조성물.
- 제2항에 있어서, 추가의 붕해제가 크로스포비돈인, 약제학적 조성물.
- 제1항에 있어서, 임의의 활제가 콜로이드성 이산화규소인, 약제학적 조성물.
- 제1항에 있어서, 제1 희석제가 만니톨이고, 제2 희석제가 예비젤라틴화 전분이고, 결합제가 코포비돈이고, 붕해제가 옥수수 전분이고, 윤활제가 스테아르산마그네슘인, 약제학적 조성물.
- 제1항에 있어서, 활성 성분 0.5 내지 20중량%, 희석제 1 40 내지 88중량%, 희석제 2 3 내지 40중량%, 결합제 1 내지 5중량%, 붕해제 5 내지 15중량% 및 윤활제 0.1 내지 4중량%를 포함하는, 약제학적 조성물.
- 제1항에 있어서, 활성 성분 0.5 내지 7중량%, 희석제 1 50 내지 75중량%, 희석제 2 5 내지 15중량%, 결합제 2 내지 4중량%, 붕해제 8 내지 12중량% 및 윤활제 0.5 내지 2중량%를 포함하는, 약제학적 조성물.
- 제1항에 있어서, 캡슐, 정제 또는 필름-피복 정제인 투여 형태인, 약제학적 조성물.
- 제13항에 있어서, 필름 피복물 2 내지 4%를 포함하는, 약제학적 조성물.
- 제1항에 있어서, 필름 피복물이 필름-형성제, 가소제, 활제 및 임의로 하나 이상의 안료를 포함하는, 약제학적 조성물.
- 제15항에 있어서, 필름 피복물이 하이드록시프로필메틸셀룰로오스(HPMC), 폴리에틸렌 글리콜(PEG), 활석, 이산화티탄 및 산화철을 포함하는, 약제학적 조성물.
- a. 결합제를 용매에 용해시켜, 과립화 액체를 제조하는 단계;b. DPP-IV 억제제, 희석제 및 붕해제를 블렌딩하여, 프리믹스를 제조하는 단계;c. 당해 프리믹스를 과립화 액체로 습윤시키고, 후속적으로 당해 습윤된 프리믹스를 과립화시키는 단계;d. 당해 과립화된 프리믹스를 1.0mm 이상의 메쉬 크기를 갖는 씨브를 통해 임의로 씨빙하는 단계;e. 당해 과립제를 약 40 내지 75℃에서, 1 내지 5% 범위의 목적하는 건조 감량이 수득될 때까지 건조시키는 단계;f. 당해 건조된 과립제를 0.6mm 이상의 메쉬 크기를 갖는 씨브를 통해 씨 빙하는 단계; 및g. 윤활제를 당해 과립제에 첨가하여 최종 블렌딩하는 단계를 포함하는, 제1항에 따르는 약제학적 조성물의 제조방법.
- 제17항에 있어서,h. 상기 최종 블렌드를 정제 코어로 되도록 압착하는 단계;i. 피복 현탁액을 제조하는 단계; 및j. 중량이 약 2 내지 4% 증가하도록 당해 정제 코어를 피복 현탁액으로 피복하여 필름-피복 정제를 제조하는 단계를 추가로 포함하는, 제1항에 따르는 약제학적 조성물의 제조방법.
- 제17항에 있어서, 단계(g)의 최종 블렌딩 이전에, 일부의 부형제가 과립외(extragranular) 첨가되는, 제1항에 따르는 약제학적 조성물의 제조방법.
- 제17항에 있어서, 단계(a) 내지 단계(e)에서 제조된 과립제가 단일용기 고전단 과립화 공정에서 제조되고, 후속적으로 단일용기 과립화기에서 건조되는, 제1항에 따르는 약제학적 조성물의 제조방법.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP06009201.2 | 2006-05-04 | ||
EP06009201A EP1852108A1 (en) | 2006-05-04 | 2006-05-04 | DPP IV inhibitor formulations |
PCT/EP2007/054204 WO2007128724A1 (en) | 2006-05-04 | 2007-04-30 | Dpp iv inhibitor formulations |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020147011768A Division KR20140063896A (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20090009226A true KR20090009226A (ko) | 2009-01-22 |
KR101478983B1 KR101478983B1 (ko) | 2015-01-05 |
Family
ID=36972901
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR20087026969A KR101478983B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020157022377A KR101710881B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020147011768A KR20140063896A (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020177035865A KR102051281B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020167029877A KR101855323B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
Family Applications After (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020157022377A KR101710881B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020147011768A KR20140063896A (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020177035865A KR102051281B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
KR1020167029877A KR101855323B1 (ko) | 2006-05-04 | 2007-04-30 | Dpp iv 억제제 제형 |
Country Status (37)
Country | Link |
---|---|
US (8) | US20080107731A1 (ko) |
EP (5) | EP1852108A1 (ko) |
JP (7) | JP5478244B2 (ko) |
KR (5) | KR101478983B1 (ko) |
CN (2) | CN102526737B (ko) |
AR (2) | AR060755A1 (ko) |
AT (1) | ATE480228T1 (ko) |
AU (1) | AU2007247193B2 (ko) |
BR (2) | BRPI0711179B1 (ko) |
CA (1) | CA2649922C (ko) |
CL (2) | CL2012002521A1 (ko) |
CY (2) | CY1111354T1 (ko) |
DE (1) | DE602007009091D1 (ko) |
DK (3) | DK2277509T5 (ko) |
EA (2) | EA029890B1 (ko) |
EC (1) | ECSP088800A (ko) |
ES (3) | ES2527409T4 (ko) |
HK (2) | HK1172549A1 (ko) |
HR (2) | HRP20100507T1 (ko) |
HU (1) | HUE025210T2 (ko) |
IL (2) | IL195030A (ko) |
ME (2) | ME01941B (ko) |
MX (2) | MX2008013958A (ko) |
MY (2) | MY146969A (ko) |
NO (1) | NO343067B1 (ko) |
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