CA3007636A1 - Vaginal inserted estradiol pharmaceutical compositions and methods - Google Patents

Vaginal inserted estradiol pharmaceutical compositions and methods Download PDF

Info

Publication number
CA3007636A1
CA3007636A1 CA3007636A CA3007636A CA3007636A1 CA 3007636 A1 CA3007636 A1 CA 3007636A1 CA 3007636 A CA3007636 A CA 3007636A CA 3007636 A CA3007636 A CA 3007636A CA 3007636 A1 CA3007636 A1 CA 3007636A1
Authority
CA
Canada
Prior art keywords
estradiol
vaginal
suppository
day
assessed
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA3007636A
Other languages
English (en)
French (fr)
Inventor
Sebastian MIRKIN
Julia M. Amadio
Brian Bernick
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
TherapeuticsMD Inc
Original Assignee
TherapeuticsMD Inc
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 TherapeuticsMD Inc filed Critical TherapeuticsMD Inc
Publication of CA3007636A1 publication Critical patent/CA3007636A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/02Suppositories; Bougies; Bases therefor; Ovules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/02Suppositories; Bougies; Bases therefor; Ovules
    • A61K9/025Suppositories; Bougies; Bases therefor; Ovules characterised by shape or structure, e.g. hollow layered, coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/04Antipruritics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/26Psychostimulants, e.g. nicotine, cocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30Oestrogens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA3007636A 2015-12-07 2016-12-07 Vaginal inserted estradiol pharmaceutical compositions and methods Pending CA3007636A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3007636A1 true CA3007636A1 (en) 2017-06-15

Family

ID=59014200

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3007636A Pending CA3007636A1 (en) 2015-12-07 2016-12-07 Vaginal inserted estradiol pharmaceutical compositions and methods

Country Status (9)

Country Link
EP (1) EP3386514A4 (ja)
JP (2) JP2018538290A (ja)
KR (1) KR20180100567A (ja)
AU (1) AU2016366200B2 (ja)
BR (1) BR112018011483A2 (ja)
CA (1) CA3007636A1 (ja)
IL (1) IL259884A (ja)
MX (1) MX2018006882A (ja)
WO (1) WO2017100378A2 (ja)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023501948A (ja) * 2019-10-31 2023-01-20 アール.ピー.シェーラー テクノロジーズ,エルエルシー 坐剤カプセル
KR102696460B1 (ko) 2021-01-20 2024-08-22 주식회사 바이올렛드림 질 내 수용성 겔 조성물

Family Cites Families (6)

* 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
CA2749235C (en) * 2004-10-20 2014-08-12 Endorecherche, Inc. Sex steroid precursors alone or in combination with a selective estrogen receptor modulator and/or with estrogens and/or a type 5 cgmp phosphodiesterase inhibitor for the prevention and treatment of vaginal dryness and sexual dysfunction in postmenopausal women
RU2740059C2 (ru) * 2012-06-18 2020-12-31 Терапьютиксмд, Инк. Капсулы с растворимым эстрадиолом для интравагинального введения
US10806697B2 (en) * 2012-12-21 2020-10-20 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

Also Published As

Publication number Publication date
IL259884A (en) 2018-07-31
AU2016366200A1 (en) 2018-06-28
MX2018006882A (es) 2019-05-16
WO2017100378A3 (en) 2018-02-22
JP2018538290A (ja) 2018-12-27
AU2016366200B2 (en) 2022-10-20
KR20180100567A (ko) 2018-09-11
JP2021119155A (ja) 2021-08-12
EP3386514A2 (en) 2018-10-17
EP3386514A4 (en) 2019-07-24
WO2017100378A2 (en) 2017-06-15
BR112018011483A2 (pt) 2018-12-04

Similar Documents

Publication Publication Date Title
US10668082B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US10835487B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US11304959B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US11246875B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20200155465A9 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20190022107A1 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20220047609A1 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
CA2926342A1 (en) Vaginal inserted estradiol pharmaceutical compositons and methods
AU2016366200B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
AU2019204658B2 (en) Vaginal Inserted Estradiol Pharmaceutical Compositions And Methods
US20230210765A1 (en) Vaginal inserted estradiol pharmaceutical compositions and methods

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122

EEER Examination request

Effective date: 20211122