JP2018522854A - １７−ヒドロキシプロゲステロンエステル含有経口組成物及び関連方法 - Google Patents

１７−ヒドロキシプロゲステロンエステル含有経口組成物及び関連方法 Download PDF

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JP2018522854A
JP2018522854A JP2017566077A JP2017566077A JP2018522854A JP 2018522854 A JP2018522854 A JP 2018522854A JP 2017566077 A JP2017566077 A JP 2017566077A JP 2017566077 A JP2017566077 A JP 2017566077A JP 2018522854 A JP2018522854 A JP 2018522854A
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hydroxyprogesterone
pharmaceutical composition
caproate
dosage form
administration
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JP2018522854A5 (enExample
Inventor
ブイ． パテル，マヘシュ
ブイ． パテル，マヘシュ
チダムバラム，ナチアッパン
ケー． ナチャエガリ，サティシュ
ケー． ナチャエガリ，サティシュ
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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 JP2018522854A5 publication Critical patent/JP2018522854A5/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
    • 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
    • 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
    • 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
    • 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
    • A61P15/06—Antiabortive agents; Labour repressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Rheumatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2017566077A 2015-06-22 2016-06-22 １７−ヒドロキシプロゲステロンエステル含有経口組成物及び関連方法 Pending JP2018522854A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562183031P 2015-06-22 2015-06-22
US62/183,031 2015-06-22
US201662295951P 2016-02-16 2016-02-16
US62/295,951 2016-02-16
PCT/US2016/038822 WO2016210003A2 (en) 2015-06-22 2016-06-22 17-hydroxyprogesterone ester-containing oral compositions and related methods

Publications (2)

Publication Number Publication Date
JP2018522854A true JP2018522854A (ja) 2018-08-16
JP2018522854A5 JP2018522854A5 (enExample) 2019-07-25

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JP2017566077A Pending JP2018522854A (ja) 2015-06-22 2016-06-22 １７−ヒドロキシプロゲステロンエステル含有経口組成物及び関連方法

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US (3) US20170035781A1 (enExample)
EP (1) EP3310359B1 (enExample)
JP (1) JP2018522854A (enExample)
CN (1) CN107847506A (enExample)
AU (1) AU2016284459B2 (enExample)
BR (1) BR112017027688A2 (enExample)
ES (1) ES3005883T3 (enExample)
IL (1) IL256493A (enExample)
MX (1) MX2017016823A (enExample)
PH (1) PH12017502416A1 (enExample)
WO (1) WO2016210003A2 (enExample)
ZA (1) ZA201801692B (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3050082A1 (en) 2016-04-04 2017-10-12 Omeza LLC Fish oil topical composition
PE20211285A1 (es) * 2018-11-27 2021-07-19 Bayer Ag Proceso para la produccion de formas farmaceuticas que contienen inhibidores de los canales task-1 y task-3 y su uso para la terapia de trastornos respiratorios
CN109662953B (zh) * 2019-02-18 2022-05-10 威海金思力生物科技股份有限公司 一种维生素d软胶囊及其制作方法
WO2021081276A1 (en) * 2019-10-23 2021-04-29 Slayback Pharma Llc Stable pharmaceutical compositions containing estradiol and progesterone for oral administration
CN111135153B (zh) * 2020-01-21 2025-08-19 安士制药（中山）有限公司 一种熊去氧胆酸胶囊及其制备方法
CN113616660A (zh) * 2020-05-07 2021-11-09 深圳埃格林医药有限公司 孕激素制剂及其用途
US12502396B2 (en) * 2020-10-27 2025-12-23 Lipocine Inc. Hydroxyprogesterone caproate compositions and methods of use in preventing preterm birth
US11370811B1 (en) 2020-11-20 2022-06-28 Lipocine Inc. (17-)-3-oxoandrost-4-en-17-yl dodecanoate compositions and methods of preparation and use
US11969434B1 (en) 2022-08-29 2024-04-30 Lipocine Inc. Oral allopregnanolone compositions and methods of use
IT202100013898A1 (it) * 2021-05-27 2022-11-27 Hulka S R L Composizione comprendente un estere di alfa-tocoferolo per la riduzione del rischio di parto pretermine
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
WO2024023173A1 (en) * 2022-07-27 2024-02-01 Ipsico Ug Solid pharmaceutical dosage form comprising a bcs class ii drug and a method for producing the same
US12186327B2 (en) 2022-08-29 2025-01-07 Lipocine Inc. Oral allopregnanolone compositions and methods of use
US12589135B2 (en) * 2023-08-21 2026-03-31 Cmpd Licensing, Llc Topical administration of GLP-1 receptor agonists

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014521660A (ja) * 2011-07-28 2014-08-28 リポカイン インコーポレーテッド １７−ヒドロキシプロゲステロンエステル含有経口組成物および関連方法

Family Cites Families (61)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3164520A (en) 1962-10-29 1965-01-05 Olin Mathieson Injectable steroid compositions containing at least 75% benzyl benzoate
NL151903B (nl) 1965-03-24 1977-01-17 Schering Ag Werkwijze ter bereiding van een injectievloeistof door een steroid op te lossen in een mengsel van ricinusolie en benzylbenzoaat.
FR2408345A1 (fr) 1976-11-30 1979-06-08 Besins Jean Louis Nouvelle composition a action anti-conceptionnelle
US4230702A (en) 1978-01-09 1980-10-28 Kali-Chemie Pharma Gmbh Readily enterally absorbable pharmaceutical compositions of per se poorly enterally absorbable pharmacologically active agents
US4439432A (en) 1982-03-22 1984-03-27 Peat Raymond F Treatment of progesterone deficiency and related conditions with a stable composition of progesterone and tocopherols
US5314882A (en) 1984-01-03 1994-05-24 International Foundation For Biochemical Endocrinology Method for promoting growth and improved meat quality in meat producing animals with female steroidal hormones
US5140021A (en) 1986-04-16 1992-08-18 Genesis Systems Corporation Method and dosage form for treatment of premenstrual syndrome
GB8730011D0 (en) 1987-12-23 1988-02-03 Smithkline Dauelsberg Pharmaceutical compositions
AU5157590A (en) 1989-02-06 1990-08-24 Abbott Laboratories Pharmaceutical compositions for oral administration
IT1252867B (it) 1991-12-31 1995-06-28 Gentili Ist Spa Composizioni farmaceutiche contenenti progesterone ad elevata biodisponibilita'
DK95093D0 (da) 1993-08-20 1993-08-20 Novo Nordisk As Farmaceutisk formulering indeholdende et hormon
US5543150A (en) 1993-09-15 1996-08-06 Columbia Laboratories, Inc. Method of progesterone delivery and affect thereof
GB9405304D0 (en) 1994-03-16 1994-04-27 Scherer Ltd R P Delivery systems for hydrophobic drugs
US5633011A (en) * 1994-08-04 1997-05-27 Alza Corporation Progesterone replacement therapy
JPH10504555A (ja) 1994-08-23 1998-05-06 デーゲーエフ ストーエス アクチェンゲゼルシャフト 無味の加水分解コラーゲンの使用及びそれを含む薬剤
DE19718012C1 (de) 1997-04-29 1998-10-08 Jenapharm Gmbh Verfahren zur Herstellung peroral anwendbarer fester Arzneiformen mit gesteuerter Wirkstoffabgabe
DE19739916C2 (de) 1997-09-11 2001-09-13 Hesch Rolf Dieter Verwendung einer Kombination aus einem Gestagen und einem Estrogen zur kontinuierlichen Ovulationshemmung und ggf. gleichzeitigen Behandlung und/oder Prophylaxe von Tumoren der Brustdrüsen
FR2772617B1 (fr) 1997-12-19 2001-03-09 Besins Iscovesco Lab Comprime de progesterone et son procede de preparation
FR2775599B1 (fr) 1998-03-09 2001-08-17 Besins Iscovesco Lab Composition pharmaceutique a base de progesterone naturelle de synthese et d'oestradiol et son procede de preparation
US6602521B1 (en) 1998-09-29 2003-08-05 Impax Pharmaceuticals, Inc. Multiplex drug delivery system suitable for oral administration
US6214815B1 (en) 1998-12-23 2001-04-10 Ortho-Mcneil Pharmaceuticals, Inc. Triphasic oral contraceptive
US7374779B2 (en) 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
US6248363B1 (en) 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US6294192B1 (en) 1999-02-26 2001-09-25 Lipocine, Inc. Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents
GB9907715D0 (en) 1999-04-01 1999-05-26 Scherer Corp R P Pharmaceutical compositions
US20030236236A1 (en) 1999-06-30 2003-12-25 Feng-Jing Chen Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs
US20020131988A1 (en) 1999-12-16 2002-09-19 Foster Todd P. Pharmaceutical implant containing immediate-release and sustained-release components and method of administration
US6544553B1 (en) 1999-12-28 2003-04-08 Watson Pharmaceuticals, Inc. Dosage forms and methods for oral delivery of progesterone
US20040022862A1 (en) 2000-12-22 2004-02-05 Kipp James E. Method for preparing small particles
FR2818905A1 (fr) 2000-12-28 2002-07-05 Cll Pharma Compositions pharmaceutiques colloidales micellaires renfermant un principe actif lipophile
FR2821555B1 (fr) 2001-03-01 2003-05-16 Besins Int Lab Progestatif co-micronise avec un tensioactif, composition pharmaceutique le comprenant, leurs procedes de fabrication et leurs utilisations
FR2832065B1 (fr) 2001-11-13 2004-11-05 Besins Int Belgique Composition pharmaceutique a base de progesterone micronisee son procede de preparation et ses utilisations
CN1622810A (zh) 2002-03-14 2005-06-01 华生制药公司 孕酮口服药物传输系统
US8216609B2 (en) 2002-08-05 2012-07-10 Torrent Pharmaceuticals Limited Modified release composition of highly soluble drugs
CN1231210C (zh) 2002-08-20 2005-12-14 杭州容立医药科技有限公司 黄体酮胶囊组合物及其制备方法
KR20050059092A (ko) 2002-08-28 2005-06-17 로버트 캐스퍼 에스트로겐 보충 요법
CN101785775B (zh) 2002-09-05 2015-03-25 潘塔希生物科学股份有限公司 15-或16-位取代的睾酮类似物的药物学应用
JP2004155780A (ja) 2002-10-16 2004-06-03 Taisho Pharmaceut Co Ltd 生活習慣病改善剤組成物
EP2218448B1 (en) 2002-12-13 2015-09-23 Durect Corporation Oral drug delivery system comprising high viscosity liquid carrier materials
CN1282459C (zh) 2002-12-24 2006-11-01 上海医药工业研究院 黄体酮胶丸及制备方法
EP1936376B1 (en) 2003-02-06 2012-04-11 Hologic Inc. Screening and treatment methods for prevention of preterm delivery
GB0305941D0 (en) 2003-03-14 2003-04-23 Camurus Ab Composition
CN1299686C (zh) 2003-04-03 2007-02-14 上海医药工业研究院 黄体酮半固体骨架制剂的组合物
CN1623550A (zh) * 2003-12-04 2005-06-08 张伟 己酸羟孕酮口服制剂和用途
JP2007516259A (ja) 2003-12-09 2007-06-21 メッドクリスタルフォームズ、エルエルシー 活性剤との混合相共結晶の調製方法
EP1735056B1 (en) 2004-03-19 2012-10-24 Warner Chilcott Company, LLC Extended cycle multiphasic oral contraceptive method
GT200500186A (es) 2004-07-07 2006-03-02 Regimenes anticonceptivos con antagonistas del receptor de progesterona y kits
US7473687B2 (en) 2005-03-24 2009-01-06 Emory University Methods for the treatment of a traumatic central nervous system injury
EP1893182B8 (en) 2005-05-26 2012-04-04 Teva Women's Health, Inc. Oral dosage forms comprising progesterone and method of making and using the same
US8828981B2 (en) 2007-02-06 2014-09-09 George Creasy Progesterone for the treatment or prevention of spontaneous preterm birth
HRP20191104T1 (hr) 2007-09-25 2019-09-20 Solubest Ltd. Pripravci koji sadrže lipofilne aktivne spojeve i postupak za njihovu pripremu
WO2009070794A1 (en) 2007-11-29 2009-06-04 Jackson Gregg A Progesterone-containing compositions and devices
US9011908B2 (en) 2009-04-06 2015-04-21 Banner Life Sciences Llc Progesterone solutions for increased bioavailability
CA2779270A1 (en) 2009-10-29 2011-05-05 The Trustees Of The University Of Pennsylvania Method of predicting risk of preterm birth
US20110152840A1 (en) 2009-12-23 2011-06-23 Drugtech Corporation Methods for reducing the occurrence of preterm delivery and other pregnancy-related conditions
US20110262502A1 (en) * 2010-02-08 2011-10-27 Prairie Pharmaceuticals LLC Pulmonary delivery of 17-hydroxyprogesterone caproate (17-hpc)
EP2544707B1 (en) 2010-03-09 2018-11-21 Dignity Health Methods for inhibiting preterm labor and uterine contractility disorders and preventing cervical ripening
US20110312928A1 (en) 2010-06-18 2011-12-22 Lipocine Inc. Progesterone Containing Oral Dosage Forms and Related Methods
US9375437B2 (en) 2010-06-18 2016-06-28 Lipocine Inc. Progesterone containing oral dosage forms and kits
US20110312927A1 (en) 2010-06-18 2011-12-22 Satish Kumar Nachaegari Progesterone Containing Oral Dosage Forms and Related Methods
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014521660A (ja) * 2011-07-28 2014-08-28 リポカイン インコーポレーテッド １７−ヒドロキシプロゲステロンエステル含有経口組成物および関連方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
灘井 雅行, 日本小児腎臓病学会雑誌, vol. 19, no. 2, JPN6020050680, 2006, pages 47 - 111, ISSN: 0004566571 *

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IL256493A (en) 2018-02-28
WO2016210003A2 (en) 2016-12-29
CN107847506A (zh) 2018-03-27
AU2016284459A1 (en) 2018-02-15
NZ739324A (en) 2024-05-31
ES3005883T3 (en) 2025-03-17
US20190275060A1 (en) 2019-09-12
ZA201801692B (en) 2019-09-25
AU2016284459B2 (en) 2021-12-23
BR112017027688A2 (pt) 2018-09-04
PH12017502416A1 (en) 2018-07-02
WO2016210003A3 (en) 2017-02-09
US11590147B2 (en) 2023-02-28
EP3310359A4 (en) 2019-04-03
EP3310359B1 (en) 2024-12-18
US20210169900A1 (en) 2021-06-10
US20170035781A1 (en) 2017-02-09
EP3310359A2 (en) 2018-04-25
MX2017016823A (es) 2018-03-12

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