EP3060179A4 - Vaginal inserted estradiol pharmaceutical compositons and methods - Google Patents

Vaginal inserted estradiol pharmaceutical compositons and methods Download PDF

Info

Publication number
EP3060179A4
EP3060179A4 EP14862905.8A EP14862905A EP3060179A4 EP 3060179 A4 EP3060179 A4 EP 3060179A4 EP 14862905 A EP14862905 A EP 14862905A EP 3060179 A4 EP3060179 A4 EP 3060179A4
Authority
EP
European Patent Office
Prior art keywords
methods
pharmaceutical compositons
vaginal
estradiol pharmaceutical
vaginal inserted
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.)
Withdrawn
Application number
EP14862905.8A
Other languages
German (de)
French (fr)
Other versions
EP3060179A1 (en
Inventor
Brian A. Bernick
Thorsteinn Thorsteinsson
Peter H. R. Persicaner
Janice Louise Cacace
Julia M. Amadio
Frederick D. SANSCILIO
Neda IRANI
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
Priority claimed from US14/099,562 external-priority patent/US8987237B2/en
Application filed by TherapeuticsMD Inc filed Critical TherapeuticsMD Inc
Priority claimed from PCT/US2014/061811 external-priority patent/WO2015073177A1/en
Publication of EP3060179A1 publication Critical patent/EP3060179A1/en
Publication of EP3060179A4 publication Critical patent/EP3060179A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
EP14862905.8A 2013-10-22 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods Withdrawn EP3060179A4 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361894411P 2013-10-22 2013-10-22
US14/099,562 US8987237B2 (en) 2011-11-23 2013-12-06 Natural combination hormone replacement formulations and therapies
US201461932140P 2014-01-27 2014-01-27
PCT/US2014/061811 WO2015073177A1 (en) 2013-10-10 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods

Publications (2)

Publication Number Publication Date
EP3060179A1 EP3060179A1 (en) 2016-08-31
EP3060179A4 true EP3060179A4 (en) 2017-05-17

Family

ID=55697531

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14862905.8A Withdrawn EP3060179A4 (en) 2013-10-22 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods

Country Status (8)

Country Link
EP (1) EP3060179A4 (en)
JP (1) JP6680672B2 (en)
KR (2) KR102335160B1 (en)
AU (3) AU2014349132A1 (en)
BR (1) BR112016009008B8 (en)
IL (1) IL245139B (en)
MX (1) MX2022002614A (en)
RU (1) RU2713888C2 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999022680A1 (en) * 1997-11-03 1999-05-14 Deschutes Medical Products, Inc. Pessary with medicated cartridge
US20130129818A1 (en) * 2011-11-23 2013-05-23 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2739558B1 (en) * 1995-10-05 1997-11-28 Innothera Lab Sa UNITAL GALENIC FORM FOR LOCAL HORMONOTHERAPY OF VAGINAL DROUGHT
FR2759292B1 (en) * 1997-02-10 2000-08-11 Cird Galderma USE OF RETINOIDS AS PIGMENTATION INDUCING AGENTS
CA2293605A1 (en) * 1998-04-11 1999-10-21 Paolo Luca Maria Giorgetti Pharmaceutical preparations containing hydrosoluble ketoprofen salts and their application
WO2003039524A1 (en) * 2001-11-09 2003-05-15 Pharmacia Ab Anti-muscarinic agent and estrogen-agonist for treating unstable or overactive bladder
AU2003290071A1 (en) * 2002-12-18 2004-07-09 Ferrer Internacional, S.A. Pharmaceutical compositions of sertaconazole for vaginal use
US20060040904A1 (en) * 2004-08-17 2006-02-23 Ahmed Salah U Vaginal cream compositions, kits thereof and methods of using thereof
JP2009504667A (en) * 2005-08-12 2009-02-05 ドラッグテック コーポレイション Estrogen composition and method of treatment by use thereof
EP1872775A1 (en) * 2006-06-29 2008-01-02 Polichem S.A. Use of a hydrophilic matrix comprising a polyacrylic acid derivative, a cellulose ether and a disintegrant for the manufacture of a medicament for treating female genital disorders
WO2013112947A1 (en) * 2012-01-26 2013-08-01 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
WO2013130535A1 (en) * 2012-02-27 2013-09-06 Newgen Biopharma Corporation Topical delivery of hormonal and non hormonal nano formulations, methods of making and using the same

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999022680A1 (en) * 1997-11-03 1999-05-14 Deschutes Medical Products, Inc. Pessary with medicated cartridge
US20130129818A1 (en) * 2011-11-23 2013-05-23 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CASTELO-BRANCO C ET AL: "Treatment of atrophic vaginitis", THERAPY, FUTURE DRUGS, LONDON, GB, vol. 4, no. 3, 1 May 2007 (2007-05-01), pages 349 - 353, XP009165326, ISSN: 1475-0708, DOI: 10.2217/14750708.4.3.349 *
CRANDALL CAROLYN: "VAGINAL ESTROGEN PREPARATIONS: A REVIEW OF SAFETY AND EFFICACY FOR VAGINAL ATROPHY", JOURNAL OF WOMEN'S HEALTH, MARY ANN LIEBERT, NEW YORK, NY, US, vol. 11, no. 10, 1 December 2002 (2002-12-01), pages 857 - 877, XP009079908, ISSN: 1059-7115 *

Also Published As

Publication number Publication date
JP6680672B2 (en) 2020-04-15
KR20210148435A (en) 2021-12-07
IL245139B (en) 2020-08-31
JP2016534025A (en) 2016-11-04
KR102488424B1 (en) 2023-01-12
BR112016009008A2 (en) 2017-08-01
IL245139A0 (en) 2016-06-30
BR112016009008B8 (en) 2023-01-31
RU2016118396A3 (en) 2018-07-17
AU2014349132A1 (en) 2016-04-14
KR20160062097A (en) 2016-06-01
AU2014349132A8 (en) 2016-07-14
AU2019204658B2 (en) 2021-05-20
RU2016118396A (en) 2017-11-28
AU2019204658A1 (en) 2019-07-18
KR102335160B1 (en) 2021-12-03
RU2713888C2 (en) 2020-02-10
BR112016009008B1 (en) 2022-09-06
MX2022002614A (en) 2022-04-11
AU2021218231A1 (en) 2021-09-09
EP3060179A1 (en) 2016-08-31

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