JP2015531400A - プロゲステロン含有経口投与形態およびキット - Google Patents

プロゲステロン含有経口投与形態およびキット Download PDF

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Publication number
JP2015531400A
JP2015531400A JP2015535845A JP2015535845A JP2015531400A JP 2015531400 A JP2015531400 A JP 2015531400A JP 2015535845 A JP2015535845 A JP 2015535845A JP 2015535845 A JP2015535845 A JP 2015535845A JP 2015531400 A JP2015531400 A JP 2015531400A
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Prior art keywords
dosage form
oral dosage
progesterone
amount
weight
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Pending
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JP2015535845A
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Japanese (ja)
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JP2015531400A5 (enExample
Inventor
クマー ナチャエガリ，サティシュ
クマー ナチャエガリ，サティシュ
ギリヤー，チャンドラシェカー
ナチアッパン，チダムバラム
パテル，マへシュ
ヴェンカテシュワラン，スリニヴァサン
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リポカイン インコーポレーテッド
リポカイン インコーポレーテッド
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Publication of JP2015531400A publication Critical patent/JP2015531400A/ja
Publication of JP2015531400A5 publication Critical patent/JP2015531400A5/ja
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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
    • A61K31/57—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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/4858—Organic compounds
    • 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
    • A61P15/18—Feminine contraceptives
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Gynecology & Obstetrics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2015535845A 2012-10-04 2013-10-04 プロゲステロン含有経口投与形態およびキット Pending JP2015531400A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13/644,929 US9375437B2 (en) 2010-06-18 2012-10-04 Progesterone containing oral dosage forms and kits
US13/644,929 2012-10-04
PCT/US2013/063584 WO2014055954A1 (en) 2012-10-04 2013-10-04 Progesterone containing oral dosage forms and kits

Publications (2)

Publication Number Publication Date
JP2015531400A true JP2015531400A (ja) 2015-11-02
JP2015531400A5 JP2015531400A5 (enExample) 2016-11-24

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Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015535845A Pending JP2015531400A (ja) 2012-10-04 2013-10-04 プロゲステロン含有経口投与形態およびキット

Country Status (9)

Country Link
US (2) US9375437B2 (enExample)
EP (1) EP2903620A4 (enExample)
JP (1) JP2015531400A (enExample)
AU (1) AU2013326866A1 (enExample)
BR (1) BR112015007642A2 (enExample)
CA (1) CA2926073A1 (enExample)
MX (1) MX2015004309A (enExample)
RU (1) RU2015116932A (enExample)
WO (1) WO2014055954A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
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JP2018057329A (ja) * 2016-10-05 2018-04-12 株式会社ディーエイチシー 油脂組成物及びカプセル剤

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US8951996B2 (en) 2011-07-28 2015-02-10 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
EP2782584B1 (en) 2011-11-23 2021-06-09 TherapeuticsMD, Inc. Natural combination hormone replacement formulations and therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
ES2907284T3 (es) 2013-03-15 2022-04-22 Marius Pharmaceuticals Llc Formulaciones de emulsión
AU2015264003A1 (en) 2014-05-22 2016-11-17 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
ES3005883T3 (en) 2015-06-22 2025-03-17 Lipocine Inc 17-hydroxyprogesterone ester-containing oral compositions and related methods
SI3313408T1 (sl) * 2015-06-23 2024-04-30 Laboratorios Leon Farma Sa Kontraceptiv na osnovi drospirenona za pacientko s prekomerno težo
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US20170281647A1 (en) * 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
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US10285998B1 (en) 2018-04-04 2019-05-14 The Menopause Method, Inc. Composition and method to aid in hormone replacement therapy
US12403146B2 (en) 2019-10-30 2025-09-02 Marius Pharmaceuticals, Inc. Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment
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US11969434B1 (en) 2022-08-29 2024-04-30 Lipocine Inc. Oral allopregnanolone compositions and methods of use
US11337987B1 (en) 2021-05-07 2022-05-24 Lipocine Inc. Compositions and methods for treating central nervous system disorders
CN116077416B (zh) * 2021-11-05 2024-12-06 深圳埃格林医药有限公司 一种包含孕激素的口服制剂及制备方法和应用
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RU2015116932A (ru) 2016-11-27
WO2014055954A1 (en) 2014-04-10
EP2903620A1 (en) 2015-08-12
EP2903620A4 (en) 2016-03-09
AU2013326866A1 (en) 2015-05-21
US9375437B2 (en) 2016-06-28
CA2926073A1 (en) 2014-04-10
US20160213687A1 (en) 2016-07-28
MX2015004309A (es) 2015-08-14
US20130029947A1 (en) 2013-01-31
BR112015007642A2 (pt) 2017-07-04

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