JP2019501199A - プロリポソームテストステロンウンデカノエート製剤 - Google Patents

プロリポソームテストステロンウンデカノエート製剤 Download PDF

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Publication number
JP2019501199A
JP2019501199A JP2018535385A JP2018535385A JP2019501199A JP 2019501199 A JP2019501199 A JP 2019501199A JP 2018535385 A JP2018535385 A JP 2018535385A JP 2018535385 A JP2018535385 A JP 2018535385A JP 2019501199 A JP2019501199 A JP 2019501199A
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JP
Japan
Prior art keywords
tsx
dosage form
oral dosage
ratio
testosterone
Prior art date
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Pending
Application number
JP2018535385A
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English (en)
Japanese (ja)
Other versions
JP2019501199A5 (enExample
Inventor
ベータゲリ グル
ベータゲリ グル
シルコーテ ラマチャンドラン
シルコーテ ラマチャンドラン
ゴウダ カダジ ビーラン
ゴウダ カダジ ビーラン
ベンカテサン ナタラジャン
ベンカテサン ナタラジャン
Original Assignee
ウエスタン ユニバーシティ オブ ヘルス サイエンシズ
ウエスタン ユニバーシティ オブ ヘルス サイエンシズ
テソクス ファーマ，リミティド ライアビリティ カンパニー
テソクス ファーマ，リミティド ライアビリティ カンパニー
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
Application filed by ウエスタン ユニバーシティ オブ ヘルス サイエンシズ, ウエスタン ユニバーシティ オブ ヘルス サイエンシズ, テソクス ファーマ，リミティド ライアビリティ カンパニー, テソクス ファーマ，リミティド ライアビリティ カンパニー filed Critical ウエスタン ユニバーシティ オブ ヘルス サイエンシズ
Publication of JP2019501199A publication Critical patent/JP2019501199A/ja
Publication of JP2019501199A5 publication Critical patent/JP2019501199A5/ja
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K9/10—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
    • 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)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Dispersion Chemistry (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)
JP2018535385A 2016-01-08 2017-01-09 プロリポソームテストステロンウンデカノエート製剤 Pending JP2019501199A (ja)

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 (2)

Publication Number Publication Date
JP2019501199A true JP2019501199A (ja) 2019-01-17
JP2019501199A5 JP2019501199A5 (enExample) 2020-02-13

Family

ID=59274044

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018535385A Pending JP2019501199A (ja) 2016-01-08 2017-01-09 プロリポソームテストステロンウンデカノエート製剤

Country Status (6)

Country Link
US (1) US20190248830A1 (enExample)
EP (1) EP3399965A4 (enExample)
JP (1) JP2019501199A (enExample)
KR (1) KR20180101452A (enExample)
CN (1) CN108601736A (enExample)
WO (1) WO2017120592A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022544197A (ja) * 2019-08-09 2022-10-17 テソリックス ファーマ， エルエルシー プロリポソームウンデカン酸テストステロン製剤

Families Citing this family (6)

* 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
RU2623206C2 (ru) 2005-04-15 2017-06-22 Кларус Терапьютикс, Инк. Фармацевтические системы доставки для гидрофобных лекарственных средств и композиций, их содержащих
ES3006512T3 (en) 2017-11-17 2025-03-18 Evonik Operations Gmbh Process for preparing a coated hard shell capsule
US12150945B2 (en) * 2018-07-20 2024-11-26 Lipocine Inc. Liver disease
US20200197413A1 (en) * 2018-12-20 2020-06-25 Clarus Therapeutics, Inc. Methods of treating testosterone deficiency
GB202307501D0 (en) * 2023-05-19 2023-07-05 Lawley Pharmaceuticals Pty Ltd Process for preparing dispensable testosterone cream

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004535383A (ja) * 2001-04-25 2004-11-25 ウエスタン センター フォー ドラッグ ディベロプメント，カレッジ オブ ファーマシー，ウエスタン ユニバーシティー オブ ヘルス サイエンシーズ プロリポソーム薬物送達システム
US20120135069A1 (en) * 2009-03-09 2012-05-31 Pharmasol Gmbh Nanonized testosteron formulations for improved bioavailability
US20140309202A1 (en) * 2010-11-30 2014-10-16 Lipocine Inc. High-strength testosterone undecanoate compositions
JP2015520751A (ja) * 2012-05-09 2015-07-23 ウエスタン ユニバーシティ オブ ヘルス サイエンシズ プロリポソーム型テストステロン調合物

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008000534A1 (de) * 2006-06-30 2008-01-03 Gertrud Langhoff Solubilisatformulierungen
WO2008114274A1 (en) * 2007-03-19 2008-09-25 Fresenius Kabi Onclology Ltd. Proliposomal and liposomal compositions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004535383A (ja) * 2001-04-25 2004-11-25 ウエスタン センター フォー ドラッグ ディベロプメント，カレッジ オブ ファーマシー，ウエスタン ユニバーシティー オブ ヘルス サイエンシーズ プロリポソーム薬物送達システム
US20120135069A1 (en) * 2009-03-09 2012-05-31 Pharmasol Gmbh Nanonized testosteron formulations for improved bioavailability
US20140309202A1 (en) * 2010-11-30 2014-10-16 Lipocine Inc. High-strength testosterone undecanoate compositions
JP2015520751A (ja) * 2012-05-09 2015-07-23 ウエスタン ユニバーシティ オブ ヘルス サイエンシズ プロリポソーム型テストステロン調合物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022544197A (ja) * 2019-08-09 2022-10-17 テソリックス ファーマ， エルエルシー プロリポソームウンデカン酸テストステロン製剤

Also Published As

Publication number Publication date
CN108601736A (zh) 2018-09-28
KR20180101452A (ko) 2018-09-12
WO2017120592A1 (en) 2017-07-13
EP3399965A4 (en) 2019-08-21
EP3399965A1 (en) 2018-11-14
US20190248830A1 (en) 2019-08-15

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