EP3386514A4 - Pharmazeutische zusammensetzungen und verfahren für vaginal eingefügtes estradiol - Google Patents

Pharmazeutische zusammensetzungen und verfahren für vaginal eingefügtes estradiol Download PDF

Info

Publication number
EP3386514A4
EP3386514A4 EP16873806.0A EP16873806A EP3386514A4 EP 3386514 A4 EP3386514 A4 EP 3386514A4 EP 16873806 A EP16873806 A EP 16873806A EP 3386514 A4 EP3386514 A4 EP 3386514A4
Authority
EP
European Patent Office
Prior art keywords
methods
pharmaceutical compositions
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Withdrawn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
EP16873806.0A
Other languages
English (en)
French (fr)
Other versions
EP3386514A2 (de
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 EP3386514A2 publication Critical patent/EP3386514A2/de
Publication of EP3386514A4 publication Critical patent/EP3386514A4/de
Withdrawn legal-status Critical Current

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)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Diabetes (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP16873806.0A 2015-12-07 2016-12-07 Pharmazeutische zusammensetzungen und verfahren für vaginal eingefügtes estradiol Withdrawn EP3386514A4 (de)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201562264309P 2015-12-07 2015-12-07
US201662296552P 2016-02-17 2016-02-17
US201662324838P 2016-04-19 2016-04-19
US201662329940P 2016-04-29 2016-04-29
US201662348820P 2016-06-10 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
EP3386514A2 EP3386514A2 (de) 2018-10-17
EP3386514A4 true EP3386514A4 (de) 2019-07-24

Family

ID=59014200

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16873806.0A Withdrawn EP3386514A4 (de) 2015-12-07 2016-12-07 Pharmazeutische zusammensetzungen und verfahren für vaginal eingefügtes estradiol

Country Status (9)

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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3159370A1 (en) * 2019-10-31 2021-05-06 R.P. Scherer Technologies, Llc Suppository capsule

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140213565A1 (en) * 2012-12-21 2014-07-31 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion

Family Cites Families (5)

* 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
BRPI0516243C1 (pt) * 2004-10-20 2021-05-25 Endorecherche Inc uso de um precursor de esteróide sexual selecionado do grupo que consiste em dehidroepiandrosterona, sulfato de dehidroepiandrosterona, androst-5-eno-3b,17b-diol e 4-androsten-3,17-diona, uso do referido precursor em 5 associação com um modulador de receptor de estrogênio seletivo para proteção uterina e da glândula mamária contra câncer, composição farmacêutica e kit
BR112014031914B1 (pt) * 2012-06-18 2021-12-14 Therapeuticsmd, Inc Formulação farmacêutica encapsulada para liberação intravaginal compreendendo estradiol e uso da mesma para o tratamento de atrofia vulvovaginal e de um sistoma associado, bem como de um estado urinário deficiente em estrogênio
US10806697B2 (en) * 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140213565A1 (en) * 2012-12-21 2014-07-31 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion

Also Published As

Publication number Publication date
CA3007636A1 (en) 2017-06-15
WO2017100378A2 (en) 2017-06-15
MX2018006882A (es) 2019-05-16
AU2016366200A1 (en) 2018-06-28
AU2016366200B2 (en) 2022-10-20
KR20180100567A (ko) 2018-09-11
EP3386514A2 (de) 2018-10-17
WO2017100378A3 (en) 2018-02-22
IL259884A (en) 2018-07-31
JP2021119155A (ja) 2021-08-12
JP2018538290A (ja) 2018-12-27
BR112018011483A2 (pt) 2018-12-04

Similar Documents

Publication Publication Date Title
EP3523437A4 (de) Oligonukleotidzusammensetzungen und verfahren dafür
EP3664816A4 (de) Oligonukleotidzusammensetzungen und verfahren dafür
EP3694530A4 (de) Oligonukleotidzusammensetzungen und verfahren dafür
EP3452596A4 (de) Oligonukleotidzusammensetzungen und verfahren dafür
EP3324978A4 (de) Oligonukleotidzusammensetzungen und verfahren dafür
EP3630145A4 (de) Pharmazeutische zusammensetzungen mit cannabidiol und beta-caryophyllen und verfahren zu ihrer verwendung
EP3355954A4 (de) Freisetzungsverfahren und zusammensetzungen
EP3357513A4 (de) Pharmazeutische zusammensetzung und verabreichung davon
EP3434285A4 (de) Pharmazeutische zusammensetzungen und verwendung davon
EP3307265A4 (de) Pharmazeutische kombination und verwendungen davon
EP3347025A4 (de) Verfahren und zusammensetzungen zur krebsbehandlung
EP3177286A4 (de) Zusammensetzungen und verfahren zur physiologischen freisetzung von cannabidiol
EP3185873A4 (de) Pharmazeutische zusammensetzung und verfahren
EP3342419A4 (de) Zusammensetzung der traditionellen chinesischen medizin zur akneentfernung und herstellungsverfahren dafür
EP3216450A4 (de) Pharmazeutische zubereitung mit cyclinhemmer und herstellungsverfahren dafür
EP3165219A4 (de) Feste allisartanisoproxyldispersion und pharmazeutische zusammensetzung damit
ZA201607148B (en) Pharmaceutical composition including anti-fungal agent and steroid
EP3512529A4 (de) Arzneimittelverabreichungszusammensetzungen und -verfahren
EP3344238A4 (de) Abführende formulierungen und herstellung
HK1245113A1 (zh) 藥物組合物及其用途
EP3328383A4 (de) Zusammensetzungen und verfahren gegen husten
EP3349748A4 (de) Zusammensetzung und verfahren dafür
EP3307275A4 (de) Injizierbare antibiotikaformulierungen und verwendung davon
EP3615005A4 (de) Zusammensetzungen und verfahren zur verabreichung von impfungen
EP3373907A4 (de) Pharmazeutische retard-zusammensetzungen und verfahren zur verwendung

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20180614

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20190621

RIC1 Information provided on ipc code assigned before grant

Ipc: A61P 15/02 20060101ALI20190614BHEP

Ipc: A61K 31/565 20060101AFI20190614BHEP

Ipc: A61K 9/48 20060101ALI20190614BHEP

Ipc: A61K 9/00 20060101ALI20190614BHEP

REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 1262604

Country of ref document: HK

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

17Q First examination report despatched

Effective date: 20201216

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20230301