KR100757656B1 - 알파 2-아드레날린 작용제 성분을 함유하는 조성물 - Google Patents
알파 2-아드레날린 작용제 성분을 함유하는 조성물 Download PDFInfo
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- KR100757656B1 KR100757656B1 KR1020027014270A KR20027014270A KR100757656B1 KR 100757656 B1 KR100757656 B1 KR 100757656B1 KR 1020027014270 A KR1020027014270 A KR 1020027014270A KR 20027014270 A KR20027014270 A KR 20027014270A KR 100757656 B1 KR100757656 B1 KR 100757656B1
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Abstract
Description
성분 | %(w/v) |
브리모니딘 타르트레이트 벤즈알코늄 클로라이드, NF 폴리비닐 알코올, USP 염화나트륨, USP 시트르산나트륨, 이수화물, USP 염산, NF 또는 pH 조정을 위한 수산화나트륨, NF 정제수, USP | 0.50 0.0050 1.4 0.66 0.45 5-8 나머지 양 |
연구 1 | 연구 2 | |||
샘플 | pHa | 용해도e | pHa | 용해도e |
1 | 5.55 | ≥164.4b | 5.50 | ≥200.6b |
2 | 5.92 | 132.6 | 5.92 | 160.8 |
3 | 6.14 | 30.4 | 6.06 | 50.1 |
4 | 6.57 | 7.55 | 6.90 | 3.19 |
5 | 7.00 | 2.69 | 7.40 | 1.19 |
6 | 7.45 | 1.17 | 7.77 | 0.63 |
7 | 7.83 | 0.62 | 7.86 | 0.58 |
8 | - | - | 7.88 | 0.54 |
처리하지 않은 대조물 | - | 0.486c | - | |
처리한 대조물 | - | 0.484d | - | |
a 2일 동안 교반시킨 후 원심분리 및 여과를 위해 샘플을 회수하기 전에 측정한 값 b 샘플 중량을 기준으로 한 이론적 농도를 나타낸다. 샘플 용액은 투명하였으며, 이것은 브리모니딘 타르트레이트가 모두 용해된 것을 나타내는 것이다. c 원심분리 및 여과 단계 전의 대조물에서의 브리모니딘 타르트레이트 농도 d 원심분리 및 여과 단계 후의 대조물에서의 브리모니딘 타르트레이트 농도 e % (w/v/) |
샘플 1 | 샘플 2 | 샘플 3 | 샘플 4 | 샘플 5 | |
브리모니딘 타르트레이트 | 0.2% | 0.2% | 0.2% | 0.2% | 0.2% (w/v) |
CMC | 0.0% | 0.056% | 0.17% | 0.5% | 1.5% (w/v) |
안정화된 이산화염소a | 0.005% | 0.005% | 0.005% | 0.005% | 0.005% (w/v) |
염화나트륨 | 0.58% | 0.58% | 0.58% | 0.58% | 0.58% (w/v) |
염화칼륨 | 0.14% | 0.14% | 0.14% | 0.14% | 0.14% (w/v) |
염화칼슘 2수화물 | 0.02% | 0.02% | 0.02% | 0.02% | 0.02% (w/v) |
염화마그네슘 6수화물 | 0.006% | 0.006% | 0.006% | 0.006% | 0.006% (w/v) |
붕산 | 0.2% | 0.2% | 0.2% | 0.2% | 0.2% (w/v) |
붕산나트륨 10수화물 | 0.14% | 0.14% | 0.14% | 0.14% | 0.14% (w/v) |
a 알러간 인코포레이트(Allergan, Inc.)에서 제품명 PuriteTM 으로 시판됨 |
브리모니딘 타르트레이트의 용해도 (%) | |||||
pH | 0% CMC | 0.056% CMC | 0.17% CMC | 0.5% CMC | 1.5% CMC |
6.67 | 0.9302 | 1.4464 | |||
6.68 | 1.4256 | 1.4200 | |||
6.93 | 0.7302 | ||||
7.10 | 0.3693 | ||||
7.11 | 0.2064 | 0.2828 | |||
7.35 | 0.1904 | ||||
7.56 | 0.1451 | ||||
7.68 | 0.0786 | ||||
7.77 | 0.0721 | ||||
7.81 | 0.0735 | ||||
8.10 | 0.0498 | ||||
8.46 | 0.0313 | ||||
8.50 | 0.0286 | ||||
8.55 | 0.0328 | ||||
8.67 | 0.0311 | ||||
9.93 | 0.0234 | ||||
9.94 | 0.0250 | ||||
10.05 | 0.0241 | ||||
10.09 | 0.0218 | ||||
10.11 | 0.0222 |
Claims (46)
- 조성물이 투여된 환자에게서 치료학적 잇점을 제공하기에 유효한 양의 5-브로모-6-(2-이미도졸린-2-일아미노) 퀴녹살린의 타르트레이트;0.1%(w/v) 내지 30%(w/v)의 카르복시메틸셀룰로오스; 및액체 담체 성분을 포함하는, 녹내장 또는 고안압을 처치하기 위한 조성물.
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- 제 1항에 있어서, 액체 담체 성분이 수성 액체 담체 성분임을 특징으로 하는 조성물.
- 제 1항에 있어서, 용액임을 특징으로 하는 조성물.
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- 제 1항에 있어서, pH가 7 내지 9 임을 특징으로 하는 조성물.
- 제 1항에 있어서, 안과적으로 허용가능함을 특징으로 하는 조성물.
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- 조성물이 투여된 환자에게서 치료학적 잇점을 제공하기에 유효한 양의 5-브로모-6-(2-이미도졸린-2-일아미노) 퀴녹살린의 타르트레이트;조성물 보존을 돕기에 유효한 양의 옥시-클로로 성분; 및액체 담체 성분을 포함하며 시클로덱스트린이 유리된, 녹내장 또는 고안압을 처치하기 위한 조성물.
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- 제 40항에 있어서, 0.1%(w/v) 내지 30%(w/v)의 카르복시메틸셀룰로오스를 추가로 포함함을 특징으로 하는 조성물.
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Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US21820000P | 2000-07-14 | 2000-07-14 | |
US60/218,200 | 2000-07-14 | ||
PCT/US2001/021552 WO2002005853A2 (en) | 2000-07-14 | 2001-07-09 | Compositions containing alpha-2-adrenergic agonist components |
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KR20030017500A KR20030017500A (ko) | 2003-03-03 |
KR100757656B1 true KR100757656B1 (ko) | 2007-09-10 |
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KR1020027014270A KR100757656B1 (ko) | 2000-07-14 | 2001-07-09 | 알파 2-아드레날린 작용제 성분을 함유하는 조성물 |
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US (4) | US6627210B2 (ko) |
EP (1) | EP1365811A2 (ko) |
JP (3) | JP4927298B2 (ko) |
KR (1) | KR100757656B1 (ko) |
CN (2) | CN101897704B (ko) |
AR (1) | AR033539A1 (ko) |
AU (2) | AU7326901A (ko) |
BR (1) | BR0109317A (ko) |
CA (1) | CA2402405C (ko) |
HK (1) | HK1060519A1 (ko) |
HU (1) | HUP0303197A3 (ko) |
IL (2) | IL151530A0 (ko) |
MX (1) | MXPA02008930A (ko) |
NO (1) | NO333367B1 (ko) |
NZ (1) | NZ521185A (ko) |
PL (1) | PL360707A1 (ko) |
RU (1) | RU2311928C2 (ko) |
TW (1) | TWI287998B (ko) |
WO (1) | WO2002005853A2 (ko) |
ZA (1) | ZA200207413B (ko) |
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