CN101848716B - 与雌激素以及一种或多种药学上可接受的赋形剂/载体组合的助孕剂用于无乳糖口服避孕药的用途 - Google Patents
与雌激素以及一种或多种药学上可接受的赋形剂/载体组合的助孕剂用于无乳糖口服避孕药的用途 Download PDFInfo
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- CN101848716B CN101848716B CN2008801148441A CN200880114844A CN101848716B CN 101848716 B CN101848716 B CN 101848716B CN 2008801148441 A CN2008801148441 A CN 2008801148441A CN 200880114844 A CN200880114844 A CN 200880114844A CN 101848716 B CN101848716 B CN 101848716B
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- Prior art keywords
- gestagen
- estrogen
- lactose
- pharmaceutical composition
- coated tablet
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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
-
- 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
- A61K31/567—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 position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/16—Masculine contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Reproductive Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Abstract
Description
配方(芯) | 1 | 2 | 3 | 4(MR)* |
活性物质 | 2mg DNG+0.03mg EO | 2mg CMA+0.03mg EO | 0.125mg LNG+0.03mg EO | 0.675mgDNG |
填充剂 | 43.52mg MCC | 43.52mg MCC | 45.395mg MCC | 58.425mgMCC |
基质形成剂 | - | - | - | 9mg羟丙甲纤维素 |
崩解剂 | 1.95mg交联羧甲纤维素钠 | 1.95mg交联羧甲纤维素钠 | 1.95mg交联羧甲纤维素钠 | 15mg玉蜀黍淀粉 |
粘合剂 | 2mg HPC | 2mg HPC | 2mg HPC | 6mg麦芽糊精 |
润滑剂 | 0.5mg硬脂酸镁 | 0.5mg硬脂酸镁 | 0.5mg硬脂酸镁 | 0.9mg硬脂酸镁 |
批号550907 | 批号621007 | 批号631007 | |
组成 | 2mg CMA、0.03mg EO、44.52mgAvicel PH 102、1mg HPC、1.95mg交联羧甲纤维素钠和0.5mg硬脂酸镁 | 2mg CMA、0.03mg EO、28.52mgAvicel PH 102、15mg Avicel PH112、2mg HPC、1.95mg交联羧甲纤维素钠和0.5mg硬脂酸镁 | 2mg CMA、0.03mg EO、36.02mgAvicel PH 101、7.5mg Avicel PH112、2mg HPC、1.95mg交联羧甲纤维素钠和0.5mg硬脂酸镁 |
在3种筛分部分(小、中和大)中的量 | 小:CMA 125%和EO 148%中:CMA 92%和EO 93%大:CMA 79%和EO 52% | 小:CMA 90.5%和EO 104.9%中:CMA 114.9%和EO 118.5%大:CMA125.9%和EO 116% | 小:CMA 99.4%和EO 107.7%中:CMA 97.3%和EO 96.9%大:CMA 111.9%和EO 102.5% |
芯在3个阶段中的CUT(合格值)理论值:<15 | 开始:CMA 2.75和EO 3.78中期:CMA 4.59和EO 5.33结束:CMA 4.68和EO 4.62 | 开始:CMA3.89和EO 4.20中期:CMA 7.15和EO 8.59结束:CMA 3.58和EO 6.71 | 开始:CMA 2.27和EO 9.65中期:CMA 3.74和EO 3.01结束:CMA 7.12和EO 9.24 |
Claims (13)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07021465A EP2055306A1 (de) | 2007-11-05 | 2007-11-05 | Verwendung eines Gestagens in Kombination mit einem Estrogen und einem oder mehreren pharmazeutisch annehmbaren hilfsstoffen/Trägern zur laktosefreien oralen Kontrazeption |
EP07021465.5 | 2007-11-05 | ||
PCT/EP2008/008900 WO2009059690A1 (de) | 2007-11-05 | 2008-10-22 | Verwendung eines gestagens in kombination mit einem estrogen und einem oder mehreren pharmazeutisch annehmbaren hilfsstoffen/ trägern zur laktosefreien oralen kontrazeption |
Publications (2)
Publication Number | Publication Date |
---|---|
CN101848716A CN101848716A (zh) | 2010-09-29 |
CN101848716B true CN101848716B (zh) | 2012-11-28 |
Family
ID=39016019
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN2008801148441A Expired - Fee Related CN101848716B (zh) | 2007-11-05 | 2008-10-22 | 与雌激素以及一种或多种药学上可接受的赋形剂/载体组合的助孕剂用于无乳糖口服避孕药的用途 |
Country Status (31)
Country | Link |
---|---|
EP (3) | EP2055306A1 (zh) |
JP (1) | JP2011502136A (zh) |
KR (1) | KR20100103794A (zh) |
CN (1) | CN101848716B (zh) |
AR (1) | AR069195A1 (zh) |
AT (1) | AT12800U1 (zh) |
AU (1) | AU2008324549A1 (zh) |
BR (1) | BRPI0819189A2 (zh) |
CA (1) | CA2704523A1 (zh) |
CO (1) | CO6270329A2 (zh) |
CR (1) | CR11413A (zh) |
DE (1) | DE202007019049U1 (zh) |
DK (1) | DK2217243T3 (zh) |
DO (1) | DOP2010000130A (zh) |
EA (1) | EA201000749A1 (zh) |
EC (1) | ECSP10010152A (zh) |
ES (1) | ES2511841T3 (zh) |
HK (1) | HK1145289A1 (zh) |
HR (1) | HRP20140962T1 (zh) |
IL (1) | IL205349A0 (zh) |
MX (1) | MX2010004975A (zh) |
NZ (1) | NZ585065A (zh) |
PA (1) | PA8803001A1 (zh) |
PE (1) | PE20091020A1 (zh) |
PL (1) | PL2217243T3 (zh) |
PT (1) | PT2217243E (zh) |
SG (1) | SG188118A1 (zh) |
TW (1) | TW200936142A (zh) |
UY (1) | UY31454A1 (zh) |
WO (1) | WO2009059690A1 (zh) |
ZA (1) | ZA201004024B (zh) |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1672685A (zh) * | 2004-03-26 | 2005-09-28 | 董可娟 | 一种新的避孕药物 |
WO2006087173A1 (de) * | 2005-02-15 | 2006-08-24 | Bayer Schering Pharma Aktiengesellschaft | Pharmazeutisches präparat zur kontrazeption |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0368373A1 (en) * | 1988-10-13 | 1990-05-16 | Akzo Nobel N.V. | Multi-phase contraceptive preparation |
US5223268A (en) * | 1991-05-16 | 1993-06-29 | Sterling Drug, Inc. | Low solubility drug-coated bead compositions |
DK95093D0 (da) * | 1993-08-20 | 1993-08-20 | Novo Nordisk As | Farmaceutisk formulering indeholdende et hormon |
US5898032A (en) * | 1997-06-23 | 1999-04-27 | Medical College Of Hampton Roads | Ultra low dose oral contraceptives with less menstrual bleeding and sustained efficacy |
JPH1171268A (ja) * | 1997-08-28 | 1999-03-16 | Kayaku:Kk | 性ホルモン含有錠剤 |
CA2260673A1 (en) | 1999-02-04 | 2000-08-04 | Natrel Inc. | A process for making a lactose-free milk without negatively affecting the organoleptic properties thereof; and milk so processed |
DE10043846A1 (de) * | 2000-09-04 | 2002-04-04 | Jenapharm Gmbh | 17-Methylensteroide, Verfahren zu deren Herstellung und diese Verbindung enthaltende pharmazeutische Zusammensetzungen |
FR2832065B1 (fr) * | 2001-11-13 | 2004-11-05 | Besins Int Belgique | Composition pharmaceutique a base de progesterone micronisee son procede de preparation et ses utilisations |
AU2004275470B2 (en) | 2003-09-29 | 2010-12-02 | Novo Nordisk Health Care Ag | Improved stability of progestogen formulations |
WO2005030175A1 (en) | 2003-09-29 | 2005-04-07 | Novo Nordisk Femcare Ag | Hrt formulations |
DE102004019406A1 (de) * | 2004-04-19 | 2005-11-03 | Schering Ag | 17α-Fluorsteroide |
DE102004026671A1 (de) * | 2004-05-28 | 2005-12-15 | Grünenthal GmbH | Darreichungsform zur hormonalen Kontrazeption |
DE102004026670A1 (de) * | 2004-05-28 | 2005-12-15 | Grünenthal GmbH | Hormonales Kontrazeptivum enthaltend eine Kombination aus Ethinylestradiol und Chlormadinonacetat |
EP1774970A1 (de) * | 2005-10-13 | 2007-04-18 | Bayer Schering Pharma AG | Verfahren zur Herstellung eines einphasigen pharmazeutischen Präparates zur Therapie der dysfunktionellen uterinen Blutung, enthaltend Ethinylestradiol und Dienogest |
-
2007
- 2007-11-05 DE DE202007019049U patent/DE202007019049U1/de not_active Expired - Lifetime
- 2007-11-05 AT ATGM371/2010U patent/AT12800U1/de not_active IP Right Cessation
- 2007-11-05 EP EP07021465A patent/EP2055306A1/de not_active Withdrawn
-
2008
- 2008-10-22 MX MX2010004975A patent/MX2010004975A/es not_active Application Discontinuation
- 2008-10-22 ES ES08847408.5T patent/ES2511841T3/es active Active
- 2008-10-22 PT PT88474085T patent/PT2217243E/pt unknown
- 2008-10-22 DK DK08847408.5T patent/DK2217243T3/da active
- 2008-10-22 AU AU2008324549A patent/AU2008324549A1/en not_active Abandoned
- 2008-10-22 JP JP2010531446A patent/JP2011502136A/ja not_active Ceased
- 2008-10-22 EP EP14164080.5A patent/EP2774614A1/de not_active Withdrawn
- 2008-10-22 CA CA2704523A patent/CA2704523A1/en not_active Abandoned
- 2008-10-22 NZ NZ585065A patent/NZ585065A/en not_active IP Right Cessation
- 2008-10-22 PL PL08847408T patent/PL2217243T3/pl unknown
- 2008-10-22 SG SG2013008883A patent/SG188118A1/en unknown
- 2008-10-22 BR BRPI0819189-1A patent/BRPI0819189A2/pt not_active IP Right Cessation
- 2008-10-22 CN CN2008801148441A patent/CN101848716B/zh not_active Expired - Fee Related
- 2008-10-22 KR KR1020107012376A patent/KR20100103794A/ko not_active Application Discontinuation
- 2008-10-22 EA EA201000749A patent/EA201000749A1/ru unknown
- 2008-10-22 EP EP08847408.5A patent/EP2217243B1/de active Active
- 2008-10-22 WO PCT/EP2008/008900 patent/WO2009059690A1/de active Application Filing
- 2008-11-04 UY UY31454A patent/UY31454A1/es unknown
- 2008-11-04 PE PE2008001887A patent/PE20091020A1/es not_active Application Discontinuation
- 2008-11-05 AR ARP080104837A patent/AR069195A1/es unknown
- 2008-11-05 TW TW097142714A patent/TW200936142A/zh unknown
- 2008-11-06 PA PA20088803001A patent/PA8803001A1/es unknown
-
2010
- 2010-04-26 IL IL205349A patent/IL205349A0/en unknown
- 2010-05-05 DO DO2010000130A patent/DOP2010000130A/es unknown
- 2010-05-05 EC EC2010010152A patent/ECSP10010152A/es unknown
- 2010-05-05 CR CR11413A patent/CR11413A/es not_active Application Discontinuation
- 2010-05-05 CO CO10053517A patent/CO6270329A2/es not_active Application Discontinuation
- 2010-06-04 ZA ZA2010/04024A patent/ZA201004024B/en unknown
- 2010-12-16 HK HK10111761.2A patent/HK1145289A1/xx not_active IP Right Cessation
-
2014
- 2014-10-07 HR HRP20140962AT patent/HRP20140962T1/hr unknown
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1672685A (zh) * | 2004-03-26 | 2005-09-28 | 董可娟 | 一种新的避孕药物 |
WO2006087173A1 (de) * | 2005-02-15 | 2006-08-24 | Bayer Schering Pharma Aktiengesellschaft | Pharmazeutisches präparat zur kontrazeption |
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