KR20010042940A - 경구 붕해성 정제 - Google Patents
경구 붕해성 정제 Download PDFInfo
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- KR20010042940A KR20010042940A KR1020007011763A KR20007011763A KR20010042940A KR 20010042940 A KR20010042940 A KR 20010042940A KR 1020007011763 A KR1020007011763 A KR 1020007011763A KR 20007011763 A KR20007011763 A KR 20007011763A KR 20010042940 A KR20010042940 A KR 20010042940A
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- KR
- South Korea
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- fine granules
- weight
- tablet according
- granules
- orally
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- HELXLJCILKEWJH-NCGAPWICSA-N rebaudioside A Chemical compound O([C@H]1[C@H](O)[C@@H](CO)O[C@H]([C@@H]1O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HELXLJCILKEWJH-NCGAPWICSA-N 0.000 description 1
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- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
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- 238000001179 sorption measurement Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
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- 230000003068 static effect Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 235000021012 strawberries Nutrition 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
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- 238000010998 test method Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 239000012749 thinning agent Substances 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- UJMBCXLDXJUMFB-UHFFFAOYSA-K trisodium;5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4h-pyrazole-3-carboxylate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)C1=NN(C=2C=CC(=CC=2)S([O-])(=O)=O)C(=O)C1N=NC1=CC=C(S([O-])(=O)=O)C=C1 UJMBCXLDXJUMFB-UHFFFAOYSA-K 0.000 description 1
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Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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Abstract
Description
체 | 중량비 |
#18 (850 ㎛) 상 | 0 % |
#30 (500 ㎛) 상 | 0 % |
#200 (75 ㎛) 상 | 100 % |
#200 (75 ㎛) 통과 | 0 % |
체 | 중량비 |
#18 (850 ㎛) 상 | 0 % |
#30 (500 ㎛) 상 | 0 % |
#200 (75 ㎛) 상 | 100 % |
#200 (75 ㎛) 통과 | 0 % |
Claims (49)
- (i) 10 중량 % 이상의 산-불안정성 생리학적 활성 물질을 갖는, 장용성 코팅층에 의해 코팅된 조성물을 포함하고, 400 ㎛ 이하의 평균 입자경을 갖는 미세 과립, 및 (ii) 첨가제를 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 미세 과립의 평균 입자경이 300 내지 400 ㎛ 인 경구 붕해성 정제.
- 제 1 항에 있어서, 미세 과립이 염기성 무기염을 더 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 첨가제가 수용성 당 알코올을 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 장용성 코팅층으로 코팅된 조성물이 수용성 당 알코올을 포함하는 코팅층으로 더 코팅된 경구 붕해성 정제.
- 제 4 항에 있어서, 첨가제가 (i) 결정질 셀룰로오스 및 /또는 (ii) 저치환도를 갖는 히드록시프로필 셀룰로오스를 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 미세 과립의 입자경이 실질적으로 425 ㎛ 이하인 경구 붕해성 정제.
- 제 1 항에 있어서, 미세 과립의 입자경이 실질적으로 400 ㎛ 이하인 경구 붕해성 정제.
- 제 1 항에 있어서, 산-불안정성 생리학적 활성 물질이 벤즈이미다졸 화합물 또는 그것의 염인 경구 붕해성 정제.
- 제 9 항에 있어서, 벤즈이미다졸 화합물이 란소프라졸인 경구 붕해성 정제.
- 제 3 항에 있어서, 염기성 무기염이 마그네슘염 및/또는 칼슘염인 경구 붕해성 정제.
- 제 1 항에 있어서, 조성물이 벤즈이미다졸 화합물 및 염기성 무기염에 의해 코팅된 핵을 포함하고, 그 핵은 결정질 셀룰로오스 및 락토오스를 포함하는 경구 붕해성 정제.
- 제 12 항에 있어서, 핵이 50 중량 % 이상의 락토오스를 포함하는 경구 붕해성 정제.
- 제 12 항에 있어서, 핵이 40 내지 50 중량 % 의 결정질 셀룰로오스, 및 50 내지 60 중량 % 의 락토오스를 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 조성물이 20 중량 % 이상의 산-불안정성 생리학적 활성 물질을 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 조성물이 20 내지 50 중량 % 의 산-불안정성 생리학적 활성 물질을 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 미세 과립이 유동층 조립법에 의해 제조되는 경구 붕해성 정제.
- 제 1 항에 있어서, 장용성 코팅층이 수성 장용성 중합체 제제를 포함하는 경구 붕해성 정제.
- 제 18 항에 있어서, 수성 장용성 중합체 제제가 메트아크릴레이트 공중합체인 경구 붕해성 정제.
- 제 18 항에 있어서, 장용성 코팅층이 서방성 제제를 더 포함하는 경구 붕해성 정제.
- 제 20 항에 있어서, 서방성 제제가 메트아크릴레이트 공중합체인 경구 붕해성 정제.
- 제 20 항에 있어서, 서방성 제제가 수성 장용성 중합체 제제 100 중량 % 에 대해 5 내지 15 중량 % 의 양인 경구 붕해성 정제.
- 제 4 항에 있어서, 수용성 당 알코올이 에리트리톨인 경구 붕해성 정제.
- 제 4 항에 있어서, 수용성 당 알코올이 만니톨인 경구 붕해성 정제.
- 제 5 항에 있어서, 수용성 당 알코올이 미세 과립과는 별도로, 경구 붕해성 정제 100 중량 % 에 대해 5 내지 97 중량 % 의 양인 경구 붕해성 정제.
- 제 4 항에 있어서, 결정질 셀룰로오스가 미세 과립과는 별도로, 정제 100 중량 % 에 대해 3 내지 50 중량 % 의 양인 경구 붕해성 정제.
- 제 6 항에 있어서, 저치환도를 갖는 히드록시프로필 셀룰로오스의 히드록시프로폭실기의 함량이 7.0 내지 9.9 중량 % 인 경구 붕해성 정제.
- 제 6 항에 있어서, 저치환도를 갖는 히드록시프로필 셀룰로오스의 히드록시프로폭실기의 함량이 5.0 내지 7.0 중량 % 인 경구 붕해성 정제.
- 제 1 항에 있어서, 크로스포비돈을 더 포함하는 경구 붕해성 정제.
- 제 1 항에 있어서, 경구 붕해 시간이 1 분 이하인 경구 붕해성 정제.
- 제 1 항에 있어서, 정제 내에 윤활제를 포함하지 않는 경구 붕해성 정제.
- 상기 조성물은 (i) 25 중량 % 이상의 산-불안정성 생리학적 활성 물질, 및 (ii) 염기성 무기염을 갖는, 장용성 코팅층에 의해 코팅된 조성물을 포함하며, 400 ㎛ 이하의 평균 입자경을 갖는 미세 과립.
- 제 32 항에 있어서, 미세 과립의 평균 입자경이 300 내지 400 ㎛ 인 미세 과립.
- 제 32 항에 있어서, 미세 과립의 입자경이 실질적으로 425 ㎛ 이하인 미세 과립.
- 제 32 항에 있어서, 미세 과립의 입자경이 실질적으로 400 ㎛ 이하인 미세 과립.
- 제 32 항에 있어서, 산-불안정성 생리학적 활성 물질이 벤즈이미다졸 화합물 또는 그것의 염인 미세 과립.
- 제 36 항에 있어서, 벤즈이미다졸 화합물이 란소프라졸인 미세 과립.
- 제 32 항에 있어서, 염기성 무기염이 마그네슘염 및/또는 칼슘염인 미세 과립.
- 제 32 항에 있어서, 조성물이 벤즈이미다졸 화합물 및 염기성 무기염에 의해 코팅되는 핵을 포함하고, 그 핵은 결정질 셀룰로오스 및 락토오스를 포함하는 미세 과립.
- 제 39 항에 있어서, 핵이 50 중량 % 이상의 락토오스를 포함하는 미세 과립.
- 제 32 항에 있어서, 조성물이 25 내지 40 중량 % 의 산-불안정성 생리학적 활성 물질을 포함하는 미세 과립.
- 제 32 항에 있어서, 유동층 조립법에 의해 제조되는 미세 과립.
- 제 32 항에 있어서, 장용성 코팅층이 수성 장용성 중합체 제제를 포함하는 미세 과립.
- 제 43 항에 있어서, 수성 장용성 중합체 제제가 메트아크릴레이트 공중합체인 미세 과립.
- 제 43 항에 있어서, 장용성 코팅층이 서방성 제제를 더 포함하는 미세 과립.
- 제 45 항에 있어서, 서방성 제제가 메트아크릴레이트 공중합체인 미세 과립.
- 제 45 항에 있어서, 서방성 제제가 수성 장용성 중합체 제제 100 중량 % 에 대해 5 내지 15 중량 % 의 양인 미세 과립.
- 제 32 항에 있어서, 장용성 코팅층이 미세 과립 100 중량 % 에 대해 50 내지 70 중량 % 의 양인 미세 과립.
- 제 32 항의 미세 과립을 포함하는 정제, 과립, 미세 과립, 캡슐, 발포제 또는 현탁액 제제.
Applications Claiming Priority (10)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP98-135472 | 1998-05-18 | ||
JP13547298 | 1998-05-18 | ||
JP98-219266 | 1998-08-03 | ||
JP21926698 | 1998-08-03 | ||
JP22215198 | 1998-08-05 | ||
JP98-222151 | 1998-08-05 | ||
JP99-5144 | 1999-01-12 | ||
JP514499 | 1999-01-12 | ||
JP99-15851 | 1999-01-25 | ||
JP1585199 | 1999-01-25 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020047021546A Division KR101032289B1 (ko) | 1998-05-18 | 1999-05-17 | 미세과립 |
Publications (2)
Publication Number | Publication Date |
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KR20010042940A true KR20010042940A (ko) | 2001-05-25 |
KR100554924B1 KR100554924B1 (ko) | 2006-03-03 |
Family
ID=27518561
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020047021546A KR101032289B1 (ko) | 1998-05-18 | 1999-05-17 | 미세과립 |
KR1020007011763A KR100554924B1 (ko) | 1998-05-18 | 1999-05-17 | 구강내 붕괴 정제 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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KR1020047021546A KR101032289B1 (ko) | 1998-05-18 | 1999-05-17 | 미세과립 |
Country Status (16)
Country | Link |
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US (5) | US6328994B1 (ko) |
EP (3) | EP1121103B1 (ko) |
JP (2) | JP3746167B2 (ko) |
KR (2) | KR101032289B1 (ko) |
CN (1) | CN1195500C (ko) |
AT (1) | ATE348601T1 (ko) |
AU (1) | AU3731699A (ko) |
CA (2) | CA2587022A1 (ko) |
CY (2) | CY1105908T1 (ko) |
DE (1) | DE69934505T2 (ko) |
DK (3) | DK1736144T3 (ko) |
ES (2) | ES2559766T3 (ko) |
HK (2) | HK1036401A1 (ko) |
PT (3) | PT1121103E (ko) |
TW (1) | TWI243062B (ko) |
WO (1) | WO1999059544A2 (ko) |
Cited By (1)
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KR20050118775A (ko) * | 2004-06-15 | 2005-12-20 | 주식회사 태평양 | 당류의 재결정화 및 약물과의 가교형성을 이용한 구강내속붕해정 |
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1999
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- 1999-05-17 ES ES06076634.2T patent/ES2559766T3/es not_active Expired - Lifetime
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- 1999-05-17 CA CA002587022A patent/CA2587022A1/en not_active Abandoned
- 1999-05-17 AT AT99919614T patent/ATE348601T1/de active
- 1999-05-17 PT PT60766342T patent/PT1736144E/pt unknown
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- 1999-05-17 DK DK99919614T patent/DK1121103T3/da active
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2000
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2001
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- 2001-09-22 HK HK07102071.1A patent/HK1096021A1/zh not_active IP Right Cessation
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2007
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2010
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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KR20050118775A (ko) * | 2004-06-15 | 2005-12-20 | 주식회사 태평양 | 당류의 재결정화 및 약물과의 가교형성을 이용한 구강내속붕해정 |
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