WO2013078422A3 - Natural combination hormone replacement formulations and therapies - Google Patents

Natural combination hormone replacement formulations and therapies Download PDF

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Publication number
WO2013078422A3
WO2013078422A3 PCT/US2012/066406 US2012066406W WO2013078422A3 WO 2013078422 A3 WO2013078422 A3 WO 2013078422A3 US 2012066406 W US2012066406 W US 2012066406W WO 2013078422 A3 WO2013078422 A3 WO 2013078422A3
Authority
WO
WIPO (PCT)
Prior art keywords
progesterone
therapies
solubilized
hormone replacement
natural combination
Prior art date
Application number
PCT/US2012/066406
Other languages
French (fr)
Other versions
WO2013078422A2 (en
Inventor
Brian A. BERNICK
Janice Louise CACACE
Peter H. R. Persicaner
Neda IRANI
Julia M. AMADIO
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48427194&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2013078422(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to HRP20211377TT priority Critical patent/HRP20211377T1/en
Priority to JP2014543585A priority patent/JP6285866B2/en
Priority to AU2012340589A priority patent/AU2012340589B2/en
Priority to PL12850845T priority patent/PL2782584T3/en
Priority to MX2014006256A priority patent/MX365818B/en
Priority to EP12850845.4A priority patent/EP2782584B1/en
Priority to RS20211088A priority patent/RS62297B1/en
Application filed by Therapeuticsmd, Inc. filed Critical Therapeuticsmd, Inc.
Priority to EP21177701.6A priority patent/EP3936133A1/en
Priority to LTEPPCT/US2012/066406T priority patent/LT2782584T/en
Priority to CA2856520A priority patent/CA2856520C/en
Priority to BR112014012444-2A priority patent/BR112014012444B1/en
Priority to ES12850845T priority patent/ES2885523T3/en
Publication of WO2013078422A2 publication Critical patent/WO2013078422A2/en
Publication of WO2013078422A3 publication Critical patent/WO2013078422A3/en
Priority to FR21C1058C priority patent/FR21C1058I2/en

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
    • A61K31/57—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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • 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
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
PCT/US2012/066406 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies WO2013078422A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
ES12850845T ES2885523T3 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
RS20211088A RS62297B1 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
AU2012340589A AU2012340589B2 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
PL12850845T PL2782584T3 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
EP21177701.6A EP3936133A1 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
EP12850845.4A EP2782584B1 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
JP2014543585A JP6285866B2 (en) 2011-11-23 2012-11-21 Natural complex hormone replacement preparations and therapies
HRP20211377TT HRP20211377T1 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
MX2014006256A MX365818B (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies.
LTEPPCT/US2012/066406T LT2782584T (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
CA2856520A CA2856520C (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
BR112014012444-2A BR112014012444B1 (en) 2011-11-23 2012-11-21 A PHARMACEUTICAL COMPOSITION COMPRISING SOLUBILIZED ESTRADIOL, PROGESTERONE AND A SOLUBILIZING AGENT, AND USES THEREOF TO TREAT A MENOPAUSE-RELATED SYMPTOM IN A WOMAN
FR21C1058C FR21C1058I2 (en) 2011-11-23 2021-12-08 PREPARATIONS AND SUBSTITUTION THERAPIES FOR COMBINED NATURAL HORMONOTHERAPY

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201161563408P 2011-11-23 2011-11-23
US61/563,408 2011-11-23
US201261661302P 2012-06-18 2012-06-18
US61/661,302 2012-06-18
US201261662265P 2012-06-20 2012-06-20
US61/662,265 2012-06-20

Publications (2)

Publication Number Publication Date
WO2013078422A2 WO2013078422A2 (en) 2013-05-30
WO2013078422A3 true WO2013078422A3 (en) 2014-12-04

Family

ID=48427194

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/066406 WO2013078422A2 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies

Country Status (14)

Country Link
US (12) US8633178B2 (en)
EP (2) EP2782584B1 (en)
JP (2) JP6285866B2 (en)
CA (1) CA2856520C (en)
ES (1) ES2885523T3 (en)
FR (1) FR21C1058I2 (en)
HR (1) HRP20211377T1 (en)
HU (1) HUE055562T2 (en)
LT (1) LT2782584T (en)
MX (1) MX365818B (en)
PL (1) PL2782584T3 (en)
PT (1) PT2782584T (en)
RS (1) RS62297B1 (en)
WO (1) WO2013078422A2 (en)

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US9795617B2 (en) 2009-06-18 2017-10-24 Baucom Institute for Longevity and Life Enhancement, Inc. Hormone delivery system and method
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
WO2013078422A2 (en) 2011-11-23 2013-05-30 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20150196640A1 (en) * 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
MX358435B (en) * 2012-06-18 2018-08-03 Therapeuticsmd Inc Soluble estradiol capsule for vaginal insertion.
US20130338122A1 (en) * 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) 2012-12-21 2022-03-08 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
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20140370084A1 (en) * 2013-06-18 2014-12-18 Therapeuticsmd, Inc. Estradiol formulations and therapies
JP6680672B2 (en) * 2013-10-10 2020-04-15 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． Vaginal inserted estradiol pharmaceutical compositions and methods
WO2015130807A1 (en) * 2014-02-25 2015-09-03 Baucom Institute for Longevity and Life Enhancement, Inc. Hormone delivery system and method
JP6591447B2 (en) * 2014-05-05 2019-10-16 レプロス セラピューティクス インコーポレイティド Formulations and methods for intravaginal delivery of antiprogestins
US10206932B2 (en) 2014-05-22 2019-02-19 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
MX2016013693A (en) * 2014-07-29 2017-10-31 Therapeuticsmd Inc Transdermal cream.
US10328087B2 (en) * 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
MX2018011706A (en) * 2016-04-01 2019-06-10 Therapeuticsmd Inc Steroid hormone pharmaceutical composition.
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
AU2017239645A1 (en) 2016-04-01 2018-10-18 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
US10285998B1 (en) 2018-04-04 2019-05-14 The Menopause Method, Inc. Composition and method to aid in hormone replacement therapy
WO2020081726A1 (en) * 2018-10-17 2020-04-23 Stadler Sarah Sheehan Methods of treating menopausal symptoms using low dose progesterone
AU2019365255A1 (en) 2018-10-26 2021-06-03 Viramal Limited Mucoadhesive gel composition
EP3947338A4 (en) * 2019-03-27 2023-01-04 Kemin Industries, Inc. Methods for preparing metal carboxylates in one-pot reaction
US11633405B2 (en) 2020-02-07 2023-04-25 Therapeuticsmd, Inc. Steroid hormone pharmaceutical formulations
US11337987B1 (en) 2021-05-07 2022-05-24 Lipocine Inc. Compositions and methods for treating central nervous system disorders
WO2023057626A1 (en) 2021-10-08 2023-04-13 Chemo Research, S.L. Oral pharmaceutical compositions of progesterone and estradiol

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