TWI345976B - Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels - Google Patents

Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels

Info

Publication number
TWI345976B
TWI345976B TW093106693A TW93106693A TWI345976B TW I345976 B TWI345976 B TW I345976B TW 093106693 A TW093106693 A TW 093106693A TW 93106693 A TW93106693 A TW 93106693A TW I345976 B TWI345976 B TW I345976B
Authority
TW
Taiwan
Prior art keywords
methods
pharmaceutical compositions
testosterone levels
serum testosterone
reliable achievement
Prior art date
Application number
TW093106693A
Other languages
English (en)
Chinese (zh)
Other versions
TW200511997A (en
Inventor
Doris Hubler
Sabine Fricke
Jan-Peter Ingwersen
Wilhelm Kuhnz
Original Assignee
Bayer Schering Pharma Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32748728&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=TWI345976(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Schering Pharma Ag filed Critical Bayer Schering Pharma Ag
Publication of TW200511997A publication Critical patent/TW200511997A/zh
Application granted granted Critical
Publication of TWI345976B publication Critical patent/TWI345976B/zh

Links

Classifications

    • 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

Landscapes

  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
TW093106693A 2003-03-14 2004-03-12 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels TWI345976B (en)

Applications Claiming Priority (1)

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

Publications (2)

Publication Number Publication Date
TW200511997A TW200511997A (en) 2005-04-01
TWI345976B true TWI345976B (en) 2011-08-01

Family

ID=32748728

Family Applications (1)

Application Number Title Priority Date Filing Date
TW093106693A TWI345976B (en) 2003-03-14 2004-03-12 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels

Country Status (39)

Country Link
US (2) US7718640B2 (enExample)
EP (2) EP1743646A3 (enExample)
JP (1) JP4680891B2 (enExample)
KR (2) KR20080096717A (enExample)
CN (2) CN101884639A (enExample)
AR (1) AR043603A1 (enExample)
AT (1) ATE336251T1 (enExample)
AU (1) AU2004218893B2 (enExample)
BR (2) BR122017008910A8 (enExample)
CA (1) CA2518910C (enExample)
CL (1) CL2004000527A1 (enExample)
CO (1) CO5700724A2 (enExample)
CR (1) CR7999A (enExample)
CY (1) CY1105794T1 (enExample)
DE (1) DE602004001893T2 (enExample)
DK (1) DK1457208T3 (enExample)
EA (1) EA011568B1 (enExample)
EC (1) ECSP056095A (enExample)
ES (1) ES2271772T3 (enExample)
HR (1) HRP20050781B1 (enExample)
IL (1) IL170473A (enExample)
IS (1) IS2565B (enExample)
JO (1) JO2505B1 (enExample)
ME (2) MEP14508A (enExample)
MX (1) MXPA04002395A (enExample)
NO (1) NO335179B1 (enExample)
NZ (1) NZ542321A (enExample)
PE (1) PE20041065A1 (enExample)
PL (1) PL1457208T3 (enExample)
PT (1) PT1457208E (enExample)
RS (1) RS51537B (enExample)
RU (2) RU2354381C2 (enExample)
SA (1) SA04250040B1 (enExample)
SI (1) SI1457208T1 (enExample)
TW (1) TWI345976B (enExample)
UA (1) UA82510C2 (enExample)
UY (1) UY28231A1 (enExample)
WO (1) WO2004080383A2 (enExample)
ZA (2) ZA200508313B (enExample)

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US20050152858A1 (en) * 2003-07-11 2005-07-14 Isp Investments Inc. Solubilizing agents for active or functional organic compounds
US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
US8241664B2 (en) * 2005-04-15 2012-08-14 Clarus Therapeutics, Inc Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
GB0807605D0 (en) * 2008-04-28 2008-06-04 Diurnal Ltd Lipid composition
AU2014200332B2 (en) * 2008-04-28 2016-10-06 Diurnal Limited Lipid composition
CA2752805A1 (en) 2009-02-18 2010-08-26 Bayer Pharma Aktiengesellschaft Formulation comprising drospirenone for subcutaneous or intramuscular administration
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
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
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
CA2872779A1 (en) * 2012-05-09 2013-11-14 Western University Of Health Sciences Proliposomal testosterone formulations
WO2014093818A2 (en) * 2012-12-14 2014-06-19 Bioject, Inc. Use of a novel subcutaneous needle-free technique to deliver testosterone in hypogonadal men
DK2953667T3 (da) * 2013-02-11 2020-01-27 Antares Pharma Inc Nålestøttet jetinjektionsindretning med reduceret udløserkraft
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
WO2015023557A1 (en) 2013-08-12 2015-02-19 Nanomedical Systems, Inc. Device and method for sustained release of low water solubility therapeutic agent in solubilizer
WO2015158823A1 (de) 2014-04-16 2015-10-22 Veyx-Pharma Gmbh Veterinärpharmazeutische zusammensetzung und deren verwendung
WO2016033549A2 (en) 2014-08-28 2016-03-03 Lipocine Inc. (17-ß)-3-OXOANDROST-4-EN-17-YL TRIDECANOATE COMPOSITIONS AND METHODS OF THEIR PREPARATION AND USE
US9498485B2 (en) 2014-08-28 2016-11-22 Lipocine Inc. Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
WO2016205423A2 (en) 2015-06-15 2016-12-22 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
CA3078723A1 (en) 2016-11-28 2018-05-31 Nachiappan Chidambaram Oral testosterone undecanoate therapy
US11311554B2 (en) 2018-04-04 2022-04-26 Slayback Pharma Llc Pharmaceutical compositions of testosterone
EP3824296B1 (en) 2018-07-20 2026-04-01 Lipocine Inc. Oral pharmaceutical composition comprising testosterone tridecanoate and/or testosterone dodecanoate for treating liver diseases
KR102051808B1 (ko) * 2018-07-23 2019-12-04 주식회사 종근당 테스토스테론 운데카노에이트를 포함하는 안정한 약제학적 조성물
CN113365635A (zh) * 2018-12-14 2021-09-07 阿克罗斯生物制药公司 睾酮的活性酯衍生物、组合物和其用途
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
EP4164743A2 (en) * 2020-06-11 2023-04-19 The United States of America, 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
KR20250176964A (ko) * 2024-06-13 2025-12-22 주식회사 종근당 타다라필 또는 이의 약학적으로 허용가능한 염을 포함하는 주사용 조성물

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Also Published As

Publication number Publication date
CA2518910A1 (en) 2004-09-23
BRPI0400214A (pt) 2005-02-09
CA2518910C (en) 2009-09-08
BRPI0400214A8 (pt) 2023-05-09
DK1457208T3 (da) 2006-12-11
US7718640B2 (en) 2010-05-18
BR122017008910A2 (enExample) 2005-02-09
DE602004001893D1 (de) 2006-09-28
IL170473A (en) 2010-05-31
US8338395B2 (en) 2012-12-25
US20090156564A1 (en) 2009-06-18
HK1069325A1 (en) 2005-05-20
RU2354381C2 (ru) 2009-05-10
RS20050702A (sr) 2007-06-04
RS51537B (sr) 2011-06-30
JO2505B1 (en) 2009-10-05
HRP20050781B1 (hr) 2015-04-10
ME00149B (me) 2010-06-10
ATE336251T1 (de) 2006-09-15
PT1457208E (pt) 2007-01-31
EP1457208A1 (en) 2004-09-15
AR043603A1 (es) 2005-08-03
JP4680891B2 (ja) 2011-05-11
CO5700724A2 (es) 2006-11-30
BR122017008910A8 (pt) 2023-05-09
WO2004080383A3 (en) 2005-03-31
NO335179B1 (no) 2014-10-13
EP1743646A3 (en) 2007-03-28
NZ542321A (en) 2008-05-30
EP1457208B1 (en) 2006-08-16
US20050032762A1 (en) 2005-02-10
AU2004218893A1 (en) 2004-09-23
WO2004080383A2 (en) 2004-09-23
SA04250040B1 (ar) 2008-01-07
NO20054711L (no) 2005-12-13
KR100882378B1 (ko) 2009-02-05
PL1457208T3 (pl) 2007-01-31
UY28231A1 (es) 2004-11-08
ZA200508313B (en) 2007-04-25
ES2271772T3 (es) 2007-04-16
EA200501819A1 (ru) 2006-06-30
CL2004000527A1 (es) 2005-02-18
MXPA04002395A (es) 2004-09-20
EA011568B1 (ru) 2009-04-28
PE20041065A1 (es) 2005-02-24
IS2565B (is) 2009-12-15
ECSP056095A (es) 2006-03-01
KR20080096717A (ko) 2008-10-31
RU2007118196A (ru) 2008-11-27
JP2006520377A (ja) 2006-09-07
CY1105794T1 (el) 2011-02-02
SI1457208T1 (sl) 2007-02-28
MEP14508A (en) 2010-06-10
CN101884639A (zh) 2010-11-17
NO20054711D0 (no) 2005-10-13
HRP20050781A2 (en) 2005-10-31
WO2004080383B1 (en) 2005-05-06
CN1761469B (zh) 2019-05-17
TW200511997A (en) 2005-04-01
IS8069A (is) 2005-10-12
AU2004218893B2 (en) 2008-10-09
KR20050109561A (ko) 2005-11-21
CN1761469A (zh) 2006-04-19
DE602004001893T2 (de) 2007-03-15
UA82510C2 (uk) 2008-04-25
EP1457208B9 (en) 2006-10-25
ZA200700046B (en) 2008-04-30
CR7999A (es) 2006-05-29
EP1743646A2 (en) 2007-01-17
RU2005131724A (ru) 2006-05-10

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