CN1285749A - 促进渗透和减少刺激的系统 - Google Patents
促进渗透和减少刺激的系统 Download PDFInfo
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- CN1285749A CN1285749A CN98813049A CN98813049A CN1285749A CN 1285749 A CN1285749 A CN 1285749A CN 98813049 A CN98813049 A CN 98813049A CN 98813049 A CN98813049 A CN 98813049A CN 1285749 A CN1285749 A CN 1285749A
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- 239000002562 thickening agent Substances 0.000 description 1
- 229940025703 topical product Drugs 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 230000007332 vesicle formation Effects 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Images
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
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- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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Abstract
Description
制剂 | 制剂成分 | 平均睾酮流出±SD | 红斑总计分120小时后,±SD |
A | T2、PG37、ET15、IPA15、KH1、O Acd 1.0 | 21.21±1.87 | 4.0±0.3 |
B | T2、PG37、ET15、IPA15、KH1、O Alc 1.0 | 15.08±3.96 | 8.7±0.3 |
制剂 | 活性剂 | 二元醇 | 醇#1 | 醇#2 | Mbr流体 | 胶凝剂 | 交联剂 | 水 |
545 | T 2.0 | PG36.6 | ET15.0 | IPA15.0 | OAlc 1.0 | C1 0.6 | TEA 0.4 | 29.4 |
546 | T 2.0 | PG36.6 | ET15.0 | IPA15.0 | OAlc 1.0 | C1 0.6 | TEA 0.4 | 29.4 |
No. | ET | IPA | PG | 0 Acd | T | IR | IR | Carb | TEA | 水 |
J | 15.0 | 15.0 | 35.6 | 1.0 | 2.0 | 1.0 | - | 0.6 | 0.4 | 29.4 |
K | 15.0 | 15.0 | 35.1 | 2.5 | 2.0 | - | - | 0.6 | 0.4 | 29.4 |
L | 15.0 | 15.0 | 34.6 | 1.0 | 2.0 | 1.0 | 1.0 | 0.6 | 0.4 | 29.4 |
制剂No. | DAA-97-602 | DAA-97-601 | DAA-97-600 |
油醇 | 15.0 | 15.0 | 15.0 |
异丙醇 | 15.0 | 15.0 | 15.0 |
丙二醇 | 35.6 | 35.1 | 34.6 |
油酸 | 1.0 | 2.5 | 2.0 |
睾酮 | 2.0 | 2.0 | 2.0 |
刺激减轻剂No.1 | 1.0 | - | 1.0 |
刺激减轻剂No.2 | - | - | 1.0 |
CARBOPOL 1342 | 0.6 | 0.6 | 0.6 |
三乙醇胺 | 0.4 | 0.4 | 0.4 |
水 | 29.4 | 29.4 | 29.4 |
成分 | 0.5% | 1.00% | 1.25% | 1.50% | 2.00% |
配方#1∶6.0配方#2∶4.5配方#6∶3.0 | 配方#11∶5.0配方#8∶3.0配方#14∶6.0配方#15∶7.0配方#16∶8.0 | 配方#3∶6.0 | 配方#7∶3.0 | 配方#4∶6.0配方#5∶3.0配方#9∶4.0配方#10∶5.0配方#12∶7.0配方#13∶8.0 | |
睾酮USP/NF | 0.50 | 1.00 | 1.25 | 1.50 | 2.00 |
Carbomer 1342 USP | 0.60 | 0.60 | 0.60 | 0.60 | 0.60 |
丙二醇USP | 35.61 | 35.44 | 35.33 | 35.23 | 35.05 |
异丙醇USP | 15.24 | 15.16 | 15.12 | 15.08 | 15.00 |
无水酒精USP | 15.24 | 15.16 | 15.12 | 15.08 | 15.00 |
油酸USP | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 |
三乙醇胺99%NF或HCl 1N | 适量至pH | 适量至pH | 适量至pH | 适量至pH | 适量至pH |
丁化羟基甲苯,NF | 0.050 | 0.050 | 0.050 | 0.050 | 0.050 |
纯水,USP | 29.87 | 29.72 | 29.64 | 29.54 | 29.40 |
制剂 | 研究# | 睾酮24小时渗透量(μg/cm2) | 皮肤上残留量酒精拭子样品(μg/cm2) | 皮肤上残留量条带(μg/cm2) | 皮肤中含量(μg/g组织) | |||||
编码#4(601) | 组成和pH2.00%试样pH 6.0 | 12345 | 平均值24.3131.3622.7646.9635.45 | 标准差3.986.094.0214.195.63 | 平均值55.459.857.279.351.2* | 标准差15.922.320.25.813.4* | 平均值18.719.615.021.429.9 | 标准差11.26.67.27.06.3 | 平均值409.3257.3267.1726.8439.0 | 标准差112.571.463.7111.5159.4 |
成 分 | %w/w | |
1.0% | 2.0% | |
睾酮,USP/NF | 1.00 | 2.00 |
乙醇,无水USP | 15.00 | 15.00 |
2-丙醇,USP | 15.00 | 15.00 |
丙二醇,USP | 35.05 | 35.05 |
油酸,NF | 2.50 | 2.50 |
丁化羟基甲苯,NF | 0.05 | 0.05 |
Carbomer,USP | 0.60 | 0.60 |
三乙醇胺,NF,适量至pH 6.0 | 0.30-0.40 | 0.30-0.40 |
纯水,USP,适量 | 30.00-29.90 | 29.00-28.90 |
总 量 | 100.00 | 100.0 |
成分 | G/20kg批量 | |
1.0% | 2.0% | |
睾酮,USP/NF | 200.00 | 400.00 |
乙醇,无水3 USP/NF | 3000.00 | 3000.00 |
2-丙醇,USP | 3000.00 | 3000.00 |
丙二醇,USP | 7010.00 | 7010.00 |
油酸,NF | 500.00 | 500.00 |
丁化羟基甲苯,NF | 10.00 | 10.00 |
Carbomer4,USP | 120.00 | 120.00 |
三乙醇胺5,NF,适量至pH 6.0 | 60.00-80.00 | 60.00-80.00 |
纯水6,USP,适量 | 6000.00-5980.00 | 5800.00-5780.00 |
总 量 | 20,000.00 | 20,000.00 |
Claims (45)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US6498097P | 1997-11-10 | 1997-11-10 | |
US60/064,980 | 1997-11-10 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1285749A true CN1285749A (zh) | 2001-02-28 |
CN1172674C CN1172674C (zh) | 2004-10-27 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB988130491A Expired - Fee Related CN1172674C (zh) | 1997-11-10 | 1998-11-09 | 促进渗透和减少刺激的系统 |
Country Status (17)
Country | Link |
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US (3) | US6319913B1 (zh) |
EP (2) | EP1030668A4 (zh) |
JP (2) | JP4139860B2 (zh) |
KR (1) | KR100648536B1 (zh) |
CN (1) | CN1172674C (zh) |
AT (1) | ATE418988T1 (zh) |
AU (1) | AU747041B2 (zh) |
BR (1) | BR9814014B1 (zh) |
CA (1) | CA2309688C (zh) |
DE (1) | DE69840426D1 (zh) |
DK (1) | DK1510213T3 (zh) |
ES (1) | ES2318233T3 (zh) |
IL (1) | IL136042A (zh) |
NO (1) | NO20002422L (zh) |
NZ (1) | NZ504423A (zh) |
PT (1) | PT1510213E (zh) |
WO (1) | WO1999024041A1 (zh) |
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-
1998
- 1998-11-09 PT PT04028426T patent/PT1510213E/pt unknown
- 1998-11-09 EP EP98956663A patent/EP1030668A4/en not_active Withdrawn
- 1998-11-09 KR KR1020007005094A patent/KR100648536B1/ko active IP Right Grant
- 1998-11-09 US US09/189,090 patent/US6319913B1/en not_active Expired - Lifetime
- 1998-11-09 AT AT04028426T patent/ATE418988T1/de active
- 1998-11-09 ES ES04028426T patent/ES2318233T3/es not_active Expired - Lifetime
- 1998-11-09 EP EP04028426A patent/EP1510213B1/en not_active Revoked
- 1998-11-09 JP JP2000520133A patent/JP4139860B2/ja not_active Expired - Fee Related
- 1998-11-09 CA CA002309688A patent/CA2309688C/en not_active Expired - Fee Related
- 1998-11-09 NZ NZ504423A patent/NZ504423A/xx not_active IP Right Cessation
- 1998-11-09 CN CNB988130491A patent/CN1172674C/zh not_active Expired - Fee Related
- 1998-11-09 WO PCT/US1998/023750 patent/WO1999024041A1/en active IP Right Grant
- 1998-11-09 IL IL13604298A patent/IL136042A/xx not_active IP Right Cessation
- 1998-11-09 AU AU13132/99A patent/AU747041B2/en not_active Ceased
- 1998-11-09 BR BRPI9814014-0A patent/BR9814014B1/pt not_active IP Right Cessation
- 1998-11-09 DE DE69840426T patent/DE69840426D1/de not_active Expired - Lifetime
- 1998-11-09 DK DK04028426T patent/DK1510213T3/da active
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2000
- 2000-05-10 NO NO20002422A patent/NO20002422L/no not_active Application Discontinuation
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2001
- 2001-09-24 US US09/963,287 patent/US6579865B2/en not_active Expired - Lifetime
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2003
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2004
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102357098A (zh) * | 2002-04-19 | 2012-02-22 | Cpex药品公司 | 药物组合物以及其用途和制备方法 |
CN102357098B (zh) * | 2002-04-19 | 2014-12-17 | Fcbi有限责任公司 | 药物组合物以及其用途和制备方法 |
CN105853396A (zh) * | 2003-03-11 | 2016-08-17 | 安塔雷斯制药Ipl股份公司 | 透皮或透粘膜应用活性剂的用途和制剂 |
CN101262843B (zh) * | 2005-09-12 | 2013-01-30 | 奇华顿股份有限公司 | 降低皮肤刺激的局部组合物 |
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US7157097B2 (en) | 2007-01-02 |
KR20010031984A (ko) | 2001-04-16 |
NZ504423A (en) | 2003-04-29 |
NO20002422L (no) | 2000-06-21 |
US20020058650A1 (en) | 2002-05-16 |
AU1313299A (en) | 1999-05-31 |
KR100648536B1 (ko) | 2006-11-24 |
DK1510213T3 (da) | 2009-03-23 |
US6319913B1 (en) | 2001-11-20 |
EP1030668A4 (en) | 2002-09-25 |
NO20002422D0 (no) | 2000-05-10 |
WO1999024041A1 (en) | 1999-05-20 |
US6579865B2 (en) | 2003-06-17 |
AU747041B2 (en) | 2002-05-09 |
EP1510213A3 (en) | 2005-03-23 |
IL136042A0 (en) | 2001-05-20 |
CA2309688A1 (en) | 1999-05-20 |
JP2005047932A (ja) | 2005-02-24 |
EP1030668A1 (en) | 2000-08-30 |
DE69840426D1 (de) | 2009-02-12 |
US20030166625A1 (en) | 2003-09-04 |
BR9814014A (pt) | 2000-09-26 |
EP1510213B1 (en) | 2008-12-31 |
CN1172674C (zh) | 2004-10-27 |
ES2318233T3 (es) | 2009-05-01 |
AU747041C (en) | 1999-05-31 |
JP4139860B2 (ja) | 2008-08-27 |
ATE418988T1 (de) | 2009-01-15 |
EP1510213A2 (en) | 2005-03-02 |
PT1510213E (pt) | 2009-02-12 |
CA2309688C (en) | 2007-04-24 |
JP2001522804A (ja) | 2001-11-20 |
IL136042A (en) | 2005-12-18 |
BR9814014B1 (pt) | 2014-10-07 |
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