AU2016366200B2 - Vaginal inserted estradiol pharmaceutical compositions and methods - Google Patents

Vaginal inserted estradiol pharmaceutical compositions and methods Download PDF

Info

Publication number
AU2016366200B2
AU2016366200B2 AU2016366200A AU2016366200A AU2016366200B2 AU 2016366200 B2 AU2016366200 B2 AU 2016366200B2 AU 2016366200 A AU2016366200 A AU 2016366200A AU 2016366200 A AU2016366200 A AU 2016366200A AU 2016366200 B2 AU2016366200 B2 AU 2016366200B2
Authority
AU
Australia
Prior art keywords
estradiol
vaginal
treatment
suppository
subject
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.)
Ceased
Application number
AU2016366200A
Other languages
English (en)
Other versions
AU2016366200A1 (en
Inventor
Julia M. Amadio
Brian Bernick
Sebastian MIRKIN
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 AU2016366200A1 publication Critical patent/AU2016366200A1/en
Application granted granted Critical
Publication of AU2016366200B2 publication Critical patent/AU2016366200B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
AU2016366200A 2015-12-07 2016-12-07 Vaginal inserted estradiol pharmaceutical compositions and methods Ceased AU2016366200B2 (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 (2)

Publication Number Publication Date
AU2016366200A1 AU2016366200A1 (en) 2018-06-28
AU2016366200B2 true AU2016366200B2 (en) 2022-10-20

Family

ID=59014200

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016366200A Ceased AU2016366200B2 (en) 2015-12-07 2016-12-07 Vaginal inserted estradiol pharmaceutical compositions and methods

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070270394A1 (en) * 2004-10-20 2007-11-22 Endorecherche, Inc. Sex steroid precursor 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
US20140213565A1 (en) * 2012-12-21 2014-07-31 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US20150164789A1 (en) * 2012-06-18 2015-06-18 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods

Family Cites Families (3)

* 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
PL2861073T3 (pl) * 2012-06-18 2021-09-27 Therapeuticsmd, Inc. Rozpuszczalna kapsułka estradiolu do wprowadzania do pochwy

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070270394A1 (en) * 2004-10-20 2007-11-22 Endorecherche, Inc. Sex steroid precursor 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
US20150164789A1 (en) * 2012-06-18 2015-06-18 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20140213565A1 (en) * 2012-12-21 2014-07-31 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion

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
JP2018538290A (ja) 2018-12-27
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
CA3007636A1 (en) 2017-06-15
MX2018006882A (es) 2019-05-16
JP2021119155A (ja) 2021-08-12

Similar Documents

Publication Publication Date Title
US10835487B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US10668082B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20240350514A1 (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
US20190343771A1 (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
AU2016366200B2 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20250387339A1 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20250387408A1 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
US20250360079A1 (en) Vaginal inserted estradiol pharmaceutical compositions and methods
AU2019204658B2 (en) Vaginal Inserted Estradiol Pharmaceutical Compositions And Methods

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)