KR100882378B1 - 허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을위한 방법 및 제약 조성물 - Google Patents

허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을위한 방법 및 제약 조성물 Download PDF

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KR100882378B1
KR100882378B1 KR1020057017087A KR20057017087A KR100882378B1 KR 100882378 B1 KR100882378 B1 KR 100882378B1 KR 1020057017087 A KR1020057017087 A KR 1020057017087A KR 20057017087 A KR20057017087 A KR 20057017087A KR 100882378 B1 KR100882378 B1 KR 100882378B1
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testosterone
cosolvent
injection
composition
vehicle
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Expired - Lifetime
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Korean (ko)
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KR20050109561A (ko
Inventor
도리스 휘블러
자비네 프리케
얀-페터 잉베르젠
빌헬름 쿤쯔
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바이엘 쉐링 파마 악티엔게젤샤프트
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Assigned to 바이엘 인텔렉쳐 프로퍼티 게엠베하 reassignment 바이엘 인텔렉쳐 프로퍼티 게엠베하 권리의 전부이전등록 Assignors: 바이엘 파마 악티엔게젤샤프트
Assigned to 그뤼넨탈 게엠베하 reassignment 그뤼넨탈 게엠베하 권리의 전부이전등록 Assignors: 바이엘 인텔렉쳐 프로퍼티 게엠베하
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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
    • 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
    • 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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Psychiatry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
KR1020057017087A 2003-03-14 2004-03-15 허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을위한 방법 및 제약 조성물 Expired - Lifetime KR100882378B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200300399 2003-03-14
DKPA200300399 2003-03-14

Related Child Applications (1)

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KR1020087025443A Division KR20080096717A (ko) 2003-03-14 2004-03-15 허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을 위한 방법 및 제약 조성물

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Publication Number Publication Date
KR20050109561A KR20050109561A (ko) 2005-11-21
KR100882378B1 true KR100882378B1 (ko) 2009-02-05

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ID=32748728

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KR1020057017087A Expired - Lifetime KR100882378B1 (ko) 2003-03-14 2004-03-15 허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을위한 방법 및 제약 조성물
KR1020087025443A Withdrawn KR20080096717A (ko) 2003-03-14 2004-03-15 허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을 위한 방법 및 제약 조성물

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KR1020087025443A Withdrawn KR20080096717A (ko) 2003-03-14 2004-03-15 허용가능한 혈청 테스토스테론 수준의 신뢰성 있는 달성을 위한 방법 및 제약 조성물

Country Status (39)

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US (2) US7718640B2 (https=)
EP (2) EP1457208B9 (https=)
JP (1) JP4680891B2 (https=)
KR (2) KR100882378B1 (https=)
CN (2) CN101884639A (https=)
AR (1) AR043603A1 (https=)
AT (1) ATE336251T1 (https=)
AU (1) AU2004218893B2 (https=)
BR (2) BRPI0400214A8 (https=)
CA (1) CA2518910C (https=)
CL (1) CL2004000527A1 (https=)
CO (1) CO5700724A2 (https=)
CR (1) CR7999A (https=)
CY (1) CY1105794T1 (https=)
DE (1) DE602004001893T2 (https=)
DK (1) DK1457208T3 (https=)
EA (1) EA011568B1 (https=)
EC (1) ECSP056095A (https=)
ES (1) ES2271772T3 (https=)
HR (1) HRP20050781B1 (https=)
IL (1) IL170473A (https=)
IS (1) IS2565B (https=)
JO (1) JO2505B1 (https=)
ME (2) ME00149B (https=)
MX (1) MXPA04002395A (https=)
NO (1) NO335179B1 (https=)
NZ (1) NZ542321A (https=)
PE (1) PE20041065A1 (https=)
PL (1) PL1457208T3 (https=)
PT (1) PT1457208E (https=)
RS (1) RS51537B (https=)
RU (2) RU2354381C2 (https=)
SA (1) SA04250040B1 (https=)
SI (1) SI1457208T1 (https=)
TW (1) TWI345976B (https=)
UA (1) UA82510C2 (https=)
UY (1) UY28231A1 (https=)
WO (1) WO2004080383A2 (https=)
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WO2020022659A1 (en) 2018-07-23 2020-01-30 Chong Kun Dang Pharmaceutical Corp. A stable pharmaceutical composition comprising testosterone undecanoate

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US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
CA2604943C (en) * 2005-04-15 2013-09-17 Clarus Therapeutics, Inc. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
AU2014200332B2 (en) * 2008-04-28 2016-10-06 Diurnal Limited Lipid composition
GB0807605D0 (en) * 2008-04-28 2008-06-04 Diurnal Ltd Lipid composition
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US9358241B2 (en) 2010-11-30 2016-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US20180153904A1 (en) 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions
US20130178454A1 (en) * 2011-11-17 2013-07-11 Shalender Bhasin Combination of testosterone and ornithine decarboxylase (odc) inhibitors
KR20150011346A (ko) * 2012-04-06 2015-01-30 안타레스 팔마, 인코퍼레이티드 테스토스테론 조성물의 바늘-보조식 젯 주입 투여 장치 및 방법
CN104780914B (zh) * 2012-05-09 2018-02-09 健康科学西部大学 前体脂质体睾酮制剂
WO2014093818A2 (en) * 2012-12-14 2014-06-19 Bioject, Inc. Use of a novel subcutaneous needle-free technique to deliver testosterone in hypogonadal men
ES2969984T3 (es) 2013-02-11 2024-05-23 Antares Pharma Inc Dispositivo de inyección por chorro asistido por aguja que tiene fuerza de disparo reducida
TW201521731A (zh) * 2013-03-15 2015-06-16 利波辛股份有限公司 用於口服之脂平衡的長鏈睪固酮酯
CN105744983B (zh) * 2013-08-12 2019-12-27 纳米医学系统公司 用于缓释在增溶剂中的低水溶性治疗剂的装置和方法
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US9498485B2 (en) 2014-08-28 2016-11-22 Lipocine Inc. Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
US20160361322A1 (en) 2015-06-15 2016-12-15 Lipocine Inc. Composition and method for oral delivery of androgen prodrugs
CN105056115A (zh) * 2015-08-05 2015-11-18 成都市飞龙水处理技术研究所 一种治疗化脓性睾丸炎的内服药物及其制备方法
US11559530B2 (en) 2016-11-28 2023-01-24 Lipocine Inc. Oral testosterone undecanoate therapy
US11311554B2 (en) 2018-04-04 2022-04-26 Slayback Pharma Llc Pharmaceutical compositions of testosterone
AU2019308326B2 (en) * 2018-07-20 2025-07-31 Lipocine Inc. Liver disease
KR20210131305A (ko) * 2018-12-14 2021-11-02 아세러스 바이오파마 인크. 테스토스테론의 활성 에스테르 유도체, 조성물 및 그의 용도
US11564933B2 (en) 2019-04-12 2023-01-31 Tolmar, Inc. Methods of treating testosterone deficiency
WO2021067600A1 (en) * 2019-10-03 2021-04-08 Caren Pharmaceuticals, Inc. Combination hormone formulations and therapies
US20230227492A1 (en) * 2020-06-11 2023-07-20 The Usa As Represented By The Secretary, Department Of Health And Human Services Monomeric and oligomeric compound embodiments as contraceptives and therapies and methods of making and using the same
US12257257B2 (en) * 2023-07-27 2025-03-25 Lipocine, Inc. Testosterone dodecanoate compositions and methods
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020022659A1 (en) 2018-07-23 2020-01-30 Chong Kun Dang Pharmaceutical Corp. A stable pharmaceutical composition comprising testosterone undecanoate
US11826460B2 (en) 2018-07-23 2023-11-28 Chong Kun Dang Pharmaceutical Corp. Stable pharmaceutical composition comprising testosterone undecanoate

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RU2007118196A (ru) 2008-11-27
HK1069325A1 (en) 2005-05-20
EP1743646A3 (en) 2007-03-28
IS2565B (is) 2009-12-15
ECSP056095A (es) 2006-03-01
EA200501819A1 (ru) 2006-06-30
RS51537B (sr) 2011-06-30
NO20054711D0 (no) 2005-10-13
CL2004000527A1 (es) 2005-02-18
UY28231A1 (es) 2004-11-08
CA2518910C (en) 2009-09-08
CN1761469A (zh) 2006-04-19
DE602004001893T2 (de) 2007-03-15
US8338395B2 (en) 2012-12-25
JO2505B1 (en) 2009-10-05
HRP20050781A2 (en) 2005-10-31
SA04250040B1 (ar) 2008-01-07
JP2006520377A (ja) 2006-09-07
UA82510C2 (uk) 2008-04-25
US20050032762A1 (en) 2005-02-10
BRPI0400214A8 (pt) 2023-05-09
ZA200508313B (en) 2007-04-25
DE602004001893D1 (de) 2006-09-28
EA011568B1 (ru) 2009-04-28
RS20050702A (sr) 2007-06-04
ME00149B (me) 2010-06-10
KR20080096717A (ko) 2008-10-31
TWI345976B (en) 2011-08-01
EP1743646A2 (en) 2007-01-17
BR122017008910A2 (https=) 2005-02-09
EP1457208A1 (en) 2004-09-15
CN1761469B (zh) 2019-05-17
IL170473A (en) 2010-05-31
PT1457208E (pt) 2007-01-31
CR7999A (es) 2006-05-29
WO2004080383A3 (en) 2005-03-31
BRPI0400214A (pt) 2005-02-09
RU2354381C2 (ru) 2009-05-10
EP1457208B9 (en) 2006-10-25
CA2518910A1 (en) 2004-09-23
ES2271772T3 (es) 2007-04-16
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HRP20050781B1 (hr) 2015-04-10
ATE336251T1 (de) 2006-09-15
NO335179B1 (no) 2014-10-13
MXPA04002395A (es) 2004-09-20
WO2004080383B1 (en) 2005-05-06
TW200511997A (en) 2005-04-01
ZA200700046B (en) 2008-04-30
AU2004218893A1 (en) 2004-09-23
CN101884639A (zh) 2010-11-17
BR122017008910A8 (pt) 2023-05-09
MEP14508A (en) 2010-06-10
CO5700724A2 (es) 2006-11-30
KR20050109561A (ko) 2005-11-21
JP4680891B2 (ja) 2011-05-11
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AR043603A1 (es) 2005-08-03
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