KR20180101452A - 프로리포솜성 테스토스테론 운데카노에이트 제제 - Google Patents

프로리포솜성 테스토스테론 운데카노에이트 제제 Download PDF

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Publication number
KR20180101452A
KR20180101452A KR1020187022494A KR20187022494A KR20180101452A KR 20180101452 A KR20180101452 A KR 20180101452A KR 1020187022494 A KR1020187022494 A KR 1020187022494A KR 20187022494 A KR20187022494 A KR 20187022494A KR 20180101452 A KR20180101452 A KR 20180101452A
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KR
South Korea
Prior art keywords
tsx
dosage form
pro
oral dosage
ratio
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Withdrawn
Application number
KR1020187022494A
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English (en)
Korean (ko)
Inventor
구루 베타게리
라마찬드란 티루코테
비란 고우다 카다지
나타라잔 벤카테산
Original Assignee
웨스턴 유니버시티 오브 헬스 사이언시스
테소륵스 파마, 엘엘씨
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Application filed by 웨스턴 유니버시티 오브 헬스 사이언시스, 테소륵스 파마, 엘엘씨 filed Critical 웨스턴 유니버시티 오브 헬스 사이언시스
Publication of KR20180101452A publication Critical patent/KR20180101452A/ko
Withdrawn legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J9/00—Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane
    • C07J9/005—Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane containing a carboxylic function directly attached or attached by a chain containing only carbon atoms to the cyclopenta[a]hydrophenanthrene skeleton
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1277—Preparation processes; Proliposomes
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
KR1020187022494A 2016-01-08 2017-01-09 프로리포솜성 테스토스테론 운데카노에이트 제제 Withdrawn KR20180101452A (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662276452P 2016-01-08 2016-01-08
US62/276,452 2016-01-08
US201662394576P 2016-09-14 2016-09-14
US62/394,576 2016-09-14
PCT/US2017/012739 WO2017120592A1 (en) 2016-01-08 2017-01-09 Proliposomal testosterone undecanoate formulations

Publications (1)

Publication Number Publication Date
KR20180101452A true KR20180101452A (ko) 2018-09-12

Family

ID=59274044

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020187022494A Withdrawn KR20180101452A (ko) 2016-01-08 2017-01-09 프로리포솜성 테스토스테론 운데카노에이트 제제

Country Status (6)

Country Link
US (1) US20190248830A1 (cg-RX-API-DMAC10.html)
EP (1) EP3399965A4 (cg-RX-API-DMAC10.html)
JP (1) JP2019501199A (cg-RX-API-DMAC10.html)
KR (1) KR20180101452A (cg-RX-API-DMAC10.html)
CN (1) CN108601736A (cg-RX-API-DMAC10.html)
WO (1) WO2017120592A1 (cg-RX-API-DMAC10.html)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
PL3709979T3 (pl) 2017-11-17 2025-03-24 Evonik Operations Gmbh Sposób wytwarzania powlekanej kapsułki twardej
EP3824296B1 (en) * 2018-07-20 2026-04-01 Lipocine Inc. Oral pharmaceutical composition comprising testosterone tridecanoate and/or testosterone dodecanoate for treating liver diseases
US20200197412A1 (en) * 2018-12-20 2020-06-25 Clarus Therapeutics, Inc. Methods of treating testosterone deficiency
US11564933B2 (en) 2019-04-12 2023-01-31 Tolmar, Inc. Methods of treating testosterone deficiency
AR122300A1 (es) * 2019-08-09 2022-08-31 Tesorxpharma Llc Formulaciones proliposomales de testosterona undecanoato
GB202307501D0 (en) * 2023-05-19 2023-07-05 Lawley Pharmaceuticals Pty Ltd Process for preparing dispensable testosterone cream

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6759058B1 (en) * 2001-04-25 2004-07-06 Western Center For Drug Development College Of Pharmacy Western University Of Health Sciences Enteric-coated proliposomal formulations for poorly water soluble drugs
WO2008000534A1 (de) * 2006-06-30 2008-01-03 Gertrud Langhoff Solubilisatformulierungen
AU2008227852B2 (en) * 2007-03-19 2011-02-24 Fresenius Kabi Oncology Ltd. Proliposomal and liposomal compositions
EP2229936B1 (en) * 2009-03-09 2015-05-06 PharmaSol GmbH Nanonized testosterone formulations for improved bioavailability
US20140309202A1 (en) * 2010-11-30 2014-10-16 Lipocine Inc. High-strength testosterone undecanoate compositions
CA2872779A1 (en) * 2012-05-09 2013-11-14 Western University Of Health Sciences Proliposomal testosterone formulations

Also Published As

Publication number Publication date
WO2017120592A1 (en) 2017-07-13
CN108601736A (zh) 2018-09-28
EP3399965A1 (en) 2018-11-14
US20190248830A1 (en) 2019-08-15
JP2019501199A (ja) 2019-01-17
EP3399965A4 (en) 2019-08-21

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Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20180803

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PC1203 Withdrawal of no request for examination
WITN Application deemed withdrawn, e.g. because no request for examination was filed or no examination fee was paid