WO2015073177A8 - Vaginal inserted estradiol pharmaceutical compositons and methods - Google Patents

Vaginal inserted estradiol pharmaceutical compositons and methods Download PDF

Info

Publication number
WO2015073177A8
WO2015073177A8 PCT/US2014/061811 US2014061811W WO2015073177A8 WO 2015073177 A8 WO2015073177 A8 WO 2015073177A8 US 2014061811 W US2014061811 W US 2014061811W WO 2015073177 A8 WO2015073177 A8 WO 2015073177A8
Authority
WO
WIPO (PCT)
Prior art keywords
methods
pharmaceutical compositons
vaginal
estradiol pharmaceutical
vaginal inserted
Prior art date
Application number
PCT/US2014/061811
Other languages
French (fr)
Other versions
WO2015073177A1 (en
Inventor
Brian A. Bernick
Thorsteinn Thorsteinsson
Peter H. R. Persicaner
Janice Louise Cacace
Julia M. Amadio
Frederick D. SANSCILIO
Neda IRANI
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
Priority to BR112016009008A priority Critical patent/BR112016009008B8/en
Priority to MX2016005092A priority patent/MX2016005092A/en
Priority to JP2016516086A priority patent/JP6680672B2/en
Priority to KR1020167010901A priority patent/KR102335160B1/en
Priority to CA2926342A priority patent/CA2926342A1/en
Priority to KR1020217039281A priority patent/KR102488424B1/en
Priority to EP14862905.8A priority patent/EP3060179A4/en
Application filed by Therapeuticsmd, Inc. filed Critical Therapeuticsmd, Inc.
Priority to RU2016118396A priority patent/RU2713888C2/en
Priority to AU2014349132A priority patent/AU2014349132A1/en
Publication of WO2015073177A1 publication Critical patent/WO2015073177A1/en
Priority to IL245139A priority patent/IL245139B/en
Publication of WO2015073177A8 publication Critical patent/WO2015073177A8/en
Priority to AU2019204658A priority patent/AU2019204658B2/en
Priority to AU2021218231A priority patent/AU2021218231A1/en

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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
PCT/US2014/061811 2013-10-10 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods WO2015073177A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
AU2014349132A AU2014349132A1 (en) 2013-10-22 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods
EP14862905.8A EP3060179A4 (en) 2013-10-22 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods
JP2016516086A JP6680672B2 (en) 2013-10-10 2014-10-22 Vaginal inserted estradiol pharmaceutical compositions and methods
KR1020167010901A KR102335160B1 (en) 2013-10-22 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods
CA2926342A CA2926342A1 (en) 2013-10-10 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods
KR1020217039281A KR102488424B1 (en) 2013-10-22 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods
RU2016118396A RU2713888C2 (en) 2013-10-10 2014-10-22 Pharmaceutical compositions and methods based on oestradiol for intravaginal introduction
BR112016009008A BR112016009008B8 (en) 2013-10-22 2014-10-22 USE OF ESTRADIOL AND/OR ESTRADIOL HEMIHYDRATE AND A SOLUBILIZING AGENT COMPRISING A MEDIUM CHAIN OIL FOR THE PREPARATION OF A PESSARY FOR THE TREATMENT OF VULVOVAGINAL ATROPHY AND A PESSARY COMPRISING ESTRADIOL
MX2016005092A MX2016005092A (en) 2013-10-10 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods.
IL245139A IL245139B (en) 2013-10-22 2016-04-14 Vaginal inserted estradiol pharmaceutical compositions and methods
AU2019204658A AU2019204658B2 (en) 2013-10-22 2019-06-28 Vaginal Inserted Estradiol Pharmaceutical Compositions And Methods
AU2021218231A AU2021218231A1 (en) 2013-10-22 2021-08-20 Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201361889483P 2013-10-10 2013-10-10
US61/889,483 2013-10-10
US201361894411P 2013-10-22 2013-10-22
US61/894,411 2013-10-22
US14/099,562 2013-12-06
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
US61/932,140 2014-01-27

Publications (2)

Publication Number Publication Date
WO2015073177A1 WO2015073177A1 (en) 2015-05-21
WO2015073177A8 true WO2015073177A8 (en) 2016-07-07

Family

ID=53140634

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/061811 WO2015073177A1 (en) 2013-10-10 2014-10-22 Vaginal inserted estradiol pharmaceutical compositons and methods

Country Status (3)

Country Link
CA (1) CA2926342A1 (en)
MX (1) MX2016005092A (en)
WO (1) WO2015073177A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2782584T (en) 2011-11-23 2021-09-02 Therapeuticsmd Inc Natural combination hormone replacement formulations and therapies
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
EP4069248A4 (en) 2019-12-06 2024-01-03 Prathima Chowdary Sustained release estrogen vaginal ring pessary for treatment of atrophy, cystitis and uterovaginal prolapse

Family Cites Families (3)

* 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
EP2806742B1 (en) * 2012-01-26 2019-03-27 TherapeuticsMD, Inc. Transdermal hormone replacement therapies
US20130224268A1 (en) * 2012-02-27 2013-08-29 Newgen Biopharma Corp. Topical delivery of hormonal and non hormonal nano formulations, methods of making and using the same

Also Published As

Publication number Publication date
WO2015073177A1 (en) 2015-05-21
MX2016005092A (en) 2016-08-17
CA2926342A1 (en) 2015-05-21

Similar Documents

Publication Publication Date Title
MX358435B (en) Soluble estradiol capsule for vaginal insertion.
PH12016500024A1 (en) Bromodomain inhibitor
WO2012112410A3 (en) Micronized placental tissue compositions and methods for making and using the same
MX2020001555A (en) Glycan therapeutics and related methods thereof.
WO2015048689A8 (en) Inhibitors of bruton's tyrosine kinase
EP3216448B8 (en) Parasiticidal oral veterinary compositions comprising systemically-acting active agents, methods and uses thereof
WO2015070224A3 (en) Combination therapy including an mdm2 inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers
IN2013MU03583A (en)
UA115558C2 (en) Alkylpyrimidine derivatives for the treatment of viral infections and further diseases
WO2012088266A3 (en) Substituted imidazopyridazines and benzimidazoles as inhibitors of fgfr3
WO2011060049A3 (en) Spiro-oxindole mdm2 antagonists
EP3520785A4 (en) Uses of bacteriostatic agent formula in preparing composition for vaginal use and composition for vaginal use
MX2015009106A (en) Solid solution compositions and use in severe pain.
WO2014144295A8 (en) Ceftolozane antibiotic compositions
WO2014180889A8 (en) Methods and compositions for the treatment of cancer
WO2015073177A8 (en) Vaginal inserted estradiol pharmaceutical compositons and methods
EP3878445A3 (en) Acamprosate formulations, methods of using the same, and combinations comprising the same
WO2015056094A3 (en) Pharmaceutical composition comprising a trpa1 antagonist and an analgesic agent
WO2015066302A3 (en) Compositions, methods of use, and methods of treatment
WO2013123249A3 (en) Formulations and methods for treating ear conditions
HK1248113A1 (en) High surface-area lyophilized compositions comprising arsenic for oral administration in patients
MX366829B (en) Itraconazole compositions and dosage forms, and methods of using the same.
MX363622B (en) New macrocyclic amidinourea derivatives, methods of preparation and uses thereof as chitinase inhibitors.
EA201492238A1 (en) COMPOSITION MIZOPROSTOL
WO2014186344A3 (en) Methods and agents for treating tyrosinase-positive albinism

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14862905

Country of ref document: EP

Kind code of ref document: A1

WPC Withdrawal of priority claims after completion of the technical preparations for international publication

Ref document number: 61/889,483

Country of ref document: US

Date of ref document: 20151204

Free format text: WITHDRAWN AFTER TECHNICAL PREPARATION FINISHED

ENP Entry into the national phase

Ref document number: 2016516086

Country of ref document: JP

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2926342

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2014349132

Country of ref document: AU

Date of ref document: 20141022

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 245139

Country of ref document: IL

WWE Wipo information: entry into national phase

Ref document number: MX/A/2016/005092

Country of ref document: MX

WWE Wipo information: entry into national phase

Ref document number: 122021023815

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 20167010901

Country of ref document: KR

Kind code of ref document: A

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112016009008

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 2016118396

Country of ref document: RU

Kind code of ref document: A

REEP Request for entry into the european phase

Ref document number: 2014862905

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2014862905

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 112016009008

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20160422