JP2018538290A - 膣挿入エストラジオール医薬組成物および方法 - Google Patents

膣挿入エストラジオール医薬組成物および方法 Download PDF

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Publication number
JP2018538290A
JP2018538290A JP2018529574A JP2018529574A JP2018538290A JP 2018538290 A JP2018538290 A JP 2018538290A JP 2018529574 A JP2018529574 A JP 2018529574A JP 2018529574 A JP2018529574 A JP 2018529574A JP 2018538290 A JP2018538290 A JP 2018538290A
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estradiol
vaginal
suppository
day
patient
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JP2018529574A
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Japanese (ja)
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JP2018538290A5 (enExample
Inventor
マーキン セバスチャン
マーキン セバスチャン
エム アマディオ ジュリア
エム アマディオ ジュリア
バーニック ブライアン
バーニック ブライアン
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TherapeuticsMD Inc
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TherapeuticsMD Inc
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Publication of JP2018538290A publication Critical patent/JP2018538290A/ja
Publication of JP2018538290A5 publication Critical patent/JP2018538290A5/ja
Priority to JP2021070619A priority Critical patent/JP2021119155A/ja
Pending legal-status Critical Current

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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
    • A61K31/565—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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • A61K9/025—Suppositories; Bougies; Bases therefor; Ovules characterised by shape or structure, e.g. hollow layered, coated
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • 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
    • 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
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • 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
    • A61P5/30—Oestrogens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

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  • 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Diabetes (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2018529574A 2015-12-07 2016-12-07 膣挿入エストラジオール医薬組成物および方法 Pending JP2018538290A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021070619A JP2021119155A (ja) 2015-12-07 2021-04-19 膣挿入エストラジオール医薬組成物および方法

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US201562264309P 2015-12-07 2015-12-07
US62/264,309 2015-12-07
US201662296552P 2016-02-17 2016-02-17
US62/296,552 2016-02-17
US201662324838P 2016-04-19 2016-04-19
US62/324,838 2016-04-19
US201662329940P 2016-04-29 2016-04-29
US62/329,940 2016-04-29
US201662348820P 2016-06-10 2016-06-10
US62/348,820 2016-06-10
PCT/US2016/065466 WO2017100378A2 (en) 2015-12-07 2016-12-07 Vaginal inserted estradiol pharmaceutical compositions and methods

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021070619A Division JP2021119155A (ja) 2015-12-07 2021-04-19 膣挿入エストラジオール医薬組成物および方法

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JP2018538290A true JP2018538290A (ja) 2018-12-27
JP2018538290A5 JP2018538290A5 (enExample) 2020-01-30

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JP2018529574A Pending JP2018538290A (ja) 2015-12-07 2016-12-07 膣挿入エストラジオール医薬組成物および方法
JP2021070619A Pending JP2021119155A (ja) 2015-12-07 2021-04-19 膣挿入エストラジオール医薬組成物および方法

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JP2021070619A Pending JP2021119155A (ja) 2015-12-07 2021-04-19 膣挿入エストラジオール医薬組成物および方法

Country Status (9)

Country Link
EP (1) EP3386514A4 (enExample)
JP (2) JP2018538290A (enExample)
KR (1) KR20180100567A (enExample)
AU (1) AU2016366200B2 (enExample)
BR (1) BR112018011483A2 (enExample)
CA (1) CA3007636A1 (enExample)
IL (1) IL259884A (enExample)
MX (1) MX384850B (enExample)
WO (1) WO2017100378A2 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220378697A1 (en) * 2019-10-31 2022-12-01 R.P. Scherer Technologies, Llc Suppository capsule
KR102696460B1 (ko) 2021-01-20 2024-08-22 주식회사 바이올렛드림 질 내 수용성 겔 조성물

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150164789A1 (en) * 2012-06-18 2015-06-18 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
JP2015519405A (ja) * 2012-06-18 2015-07-09 セラピューティックスエムディー インコーポレーテッドＴｈｅｒａｐｅｕｔｉｃｓｍｄ， Ｉｎｃ． 膣内挿入用可溶性エストラジオールカプセル

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2739558B1 (fr) * 1995-10-05 1997-11-28 Innothera Lab Sa Forme galenique unitaire pour hormonotherapie locale de la secheresse vaginale
US6117446A (en) * 1999-01-26 2000-09-12 Place; Virgil A. Drug dosage unit for buccal administration of steroidal active agents
MX368189B (es) * 2004-10-20 2019-09-23 Endorecherche Inc Precursores esteroides sexuales solos o en combinación con un modulador receptor de estrógeno selectivo y/o con estrógenos y/o con un inhibidor de fosfodiesterasa gmpc de tipo 5 para la prevención y tratamiento de sequedad vaginal y disfunción sexual en mujeres post-menopáusicas.
US9180091B2 (en) * 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150164789A1 (en) * 2012-06-18 2015-06-18 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
JP2015519405A (ja) * 2012-06-18 2015-07-09 セラピューティックスエムディー インコーポレーテッドＴｈｅｒａｐｅｕｔｉｃｓｍｄ， Ｉｎｃ． 膣内挿入用可溶性エストラジオールカプセル

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
UNITED STATES SECURITIES AND EXCHANGE COMMISION, JPN6020039733, 17 November 2015 (2015-11-17), pages 1 - 48, ISSN: 0004528017 *

Also Published As

Publication number Publication date
BR112018011483A2 (pt) 2018-12-04
MX384850B (es) 2025-03-14
KR20180100567A (ko) 2018-09-11
EP3386514A4 (en) 2019-07-24
WO2017100378A3 (en) 2018-02-22
EP3386514A2 (en) 2018-10-17
WO2017100378A2 (en) 2017-06-15
AU2016366200A1 (en) 2018-06-28
IL259884A (en) 2018-07-31
AU2016366200B2 (en) 2022-10-20
CA3007636A1 (en) 2017-06-15
MX2018006882A (es) 2019-05-16
JP2021119155A (ja) 2021-08-12

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