AR095538A1 - Composiciones farmacéuticas de ésteres de testosterona de cadena larga lipoequilibrados para la administración oral - Google Patents

Composiciones farmacéuticas de ésteres de testosterona de cadena larga lipoequilibrados para la administración oral

Info

Publication number
AR095538A1
AR095538A1 ARP140101150A ARP140101150A AR095538A1 AR 095538 A1 AR095538 A1 AR 095538A1 AR P140101150 A ARP140101150 A AR P140101150A AR P140101150 A ARP140101150 A AR P140101150A AR 095538 A1 AR095538 A1 AR 095538A1
Authority
AR
Argentina
Prior art keywords
testosterone
pharmaceutical compositions
lipoequilibrated
oral administration
long chain
Prior art date
Application number
ARP140101150A
Other languages
English (en)
Inventor
Nachiappan Chidambaram
Giliyar Chandrashekar
Patel Raj
Venkateshwaran Srinivansan
Kumar Nachaegari Satish
V Patel Mahesh
Original Assignee
Lipocine Inc
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
Priority claimed from US13/843,403 external-priority patent/US20130225544A1/en
Application filed by Lipocine Inc filed Critical Lipocine Inc
Publication of AR095538A1 publication Critical patent/AR095538A1/es

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
    • 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
    • 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
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente descripción se refiere a composiciones farmacéuticas y formas farmacéuticas orales que contienen ésteres de testosterona seleccionados y a métodos relacionados. En una realización, se proporciona una composición farmacéutica oral para su administración a sujetos que necesitan testosterona. Reivindicación 1: Composición farmacéutica oral para su administración a sujetos que necesitan testosterona, que comprende: un éster de testosterona que tiene una estructura de fórmula (1) en la que R es -C₁₃H₂₅O o -C₁₄H₂₇O, y uno o ambos ésteres pueden estar presentes en la composición farmacéutica oral; y un portador farmacéuticamente aceptable, en la que, tras la administración de dosis única a un grupo de sujetos humanos, la composición proporciona una Cₚʳₒₘ. ₜ₁₂₋ₜ₂₄ de testosterona en suero media que está dentro de aproximadamente el 35% a aproximadamente el 70% de la Cₚʳₒₘ. ₜ₀₋ₜ₂₄ de testosterona en suero media.
ARP140101150A 2013-03-15 2014-03-14 Composiciones farmacéuticas de ésteres de testosterona de cadena larga lipoequilibrados para la administración oral AR095538A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US13/843,403 US20130225544A1 (en) 2009-01-08 2013-03-15 Lipobalanced long chain testosterone esters for oral delivery

Publications (1)

Publication Number Publication Date
AR095538A1 true AR095538A1 (es) 2015-10-21

Family

ID=51538095

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP140101150A AR095538A1 (es) 2013-03-15 2014-03-14 Composiciones farmacéuticas de ésteres de testosterona de cadena larga lipoequilibrados para la administración oral

Country Status (16)

Country Link
US (2) US20160193227A1 (es)
EP (2) EP3797762A1 (es)
JP (1) JP6307711B2 (es)
KR (1) KR102238478B1 (es)
CN (1) CN105073118A (es)
AR (1) AR095538A1 (es)
AU (2) AU2014232475A1 (es)
BR (1) BR112015020849A2 (es)
CA (1) CA2942005C (es)
IL (1) IL240958B (es)
MX (1) MX2015010594A (es)
RU (1) RU2722592C2 (es)
TW (1) TW201521731A (es)
UY (1) UY35445A (es)
WO (1) WO2014145781A1 (es)
ZA (1) ZA201507700B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018102618A1 (en) 2016-11-30 2018-06-07 Lipocine Inc. Oral testosterone tridecanoate therapy
JP6945874B2 (ja) * 2019-12-24 2021-10-06 一般財団法人バイオダイナミックス研究所 経口投与用医薬組成物
WO2024005770A1 (en) * 2022-06-22 2024-01-04 Lipocine, Inc. (17-)-3-oxoandrost-4-en-17-yl dodecanoate compositions and methods of preparation and use

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL189235C (nl) * 1974-02-28 1993-02-16 Akzo Nv Werkwijze voor de bereiding van een oraal toe te dienen farmaceutisch preparaat met androgene werking.
US4147783A (en) * 1974-02-28 1979-04-03 Akzona Incorporated Oral pharmaceutical preparation
GB1567515A (en) * 1976-05-28 1980-05-14 Akzo Nv Esters of testo-sterone and 5 -dihydro-testosterone
US20050101517A1 (en) * 2000-08-23 2005-05-12 Henrick De Nijs Novel testosterone ester formulation for human use
US20030022875A1 (en) * 2001-07-27 2003-01-30 Wilson Leland F. As-needed administration of orally active androgenic agents to enhance female sexual desire and responsiveness
JO2505B1 (en) * 2003-03-14 2009-10-05 باير شيرنغ فارما اكتنجيسيلشافت Pharmacy methods and formulations for obtaining acceptable serum testosterone levels
US7138389B2 (en) * 2004-02-09 2006-11-21 University Of Washington Oral androgen therapy using modulators of testosterone bioavailability
AU2006236564B2 (en) * 2005-04-15 2011-02-17 Tolmar, Inc. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
US8492369B2 (en) * 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
CN101217963A (zh) * 2005-04-15 2008-07-09 克劳拉斯医疗有限公司 疏水性药物给药系统及含有疏水性药物的组合物
US9034858B2 (en) * 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions

Also Published As

Publication number Publication date
AU2014232475A1 (en) 2015-08-06
AU2019200097B2 (en) 2021-02-04
JP6307711B2 (ja) 2018-04-11
AU2019200097A1 (en) 2019-01-31
CA2942005A1 (en) 2014-09-18
US20160193228A1 (en) 2016-07-07
RU2015128028A (ru) 2017-04-21
EP3797762A1 (en) 2021-03-31
CA2942005C (en) 2022-02-01
UY35445A (es) 2014-10-31
BR112015020849A2 (pt) 2017-07-18
IL240958B (en) 2019-07-31
IL240958A0 (en) 2015-11-30
RU2722592C2 (ru) 2020-06-02
MX2015010594A (es) 2015-12-16
KR20150129671A (ko) 2015-11-20
CN105073118A (zh) 2015-11-18
JP2016514706A (ja) 2016-05-23
EP2968363A4 (en) 2016-08-17
US20160193227A1 (en) 2016-07-07
EP2968363A1 (en) 2016-01-20
ZA201507700B (en) 2017-02-22
KR102238478B1 (ko) 2021-04-09
EP2968363B1 (en) 2020-08-19
TW201521731A (zh) 2015-06-16
WO2014145781A1 (en) 2014-09-18

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