ATE543489T1 - Orale dosierformen mit progesteron und verwendungs- und herstellungsverfahren dafür - Google Patents

Orale dosierformen mit progesteron und verwendungs- und herstellungsverfahren dafür

Info

Publication number
ATE543489T1
ATE543489T1 AT06771398T AT06771398T ATE543489T1 AT E543489 T1 ATE543489 T1 AT E543489T1 AT 06771398 T AT06771398 T AT 06771398T AT 06771398 T AT06771398 T AT 06771398T AT E543489 T1 ATE543489 T1 AT E543489T1
Authority
AT
Austria
Prior art keywords
dosage form
methods
manufacturing
dosage forms
oral dosage
Prior art date
Application number
AT06771398T
Other languages
English (en)
Inventor
Salah Ahmed
Charles Diliberti
Chandra Vattikonda
Sudhir Gorukanti
Sanjeev Gupta
Original Assignee
Teva Womens Health 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 Teva Womens Health Inc filed Critical Teva Womens Health Inc
Application granted granted Critical
Publication of ATE543489T1 publication Critical patent/ATE543489T1/de

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
    • A61K9/4858—Organic compounds
    • 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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1664—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
    • 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
    • A61K9/485—Inorganic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular 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
    • 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
    • A61P15/06—Antiabortive agents; Labour repressants
    • 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
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
AT06771398T 2005-05-26 2006-05-26 Orale dosierformen mit progesteron und verwendungs- und herstellungsverfahren dafür ATE543489T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68455705P 2005-05-26 2005-05-26
PCT/US2006/020609 WO2006128057A2 (en) 2005-05-26 2006-05-26 Oral dosage forms comprising progesterone and methods of making and using the same

Publications (1)

Publication Number Publication Date
ATE543489T1 true ATE543489T1 (de) 2012-02-15

Family

ID=37452932

Family Applications (1)

Application Number Title Priority Date Filing Date
AT06771398T ATE543489T1 (de) 2005-05-26 2006-05-26 Orale dosierformen mit progesteron und verwendungs- und herstellungsverfahren dafür

Country Status (8)

Country Link
US (1) US8663681B2 (de)
EP (1) EP1893182B8 (de)
AT (1) ATE543489T1 (de)
AU (1) AU2006249349B2 (de)
CA (1) CA2609192A1 (de)
EA (1) EA015155B1 (de)
ES (1) ES2381495T3 (de)
WO (1) WO2006128057A2 (de)

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EP2124900B1 (de) * 2006-12-20 2014-12-03 Teva Women's Health, Inc. Im mund zerfallende feste dosierformen mit progestin und verfahren zu ihrer herstellung und verwendung
AU2014202051C1 (en) * 2007-02-06 2021-04-22 Columbia Laboratories (Bermuda) Limited Progesterone for the treatment of preterm birth
US8828981B2 (en) * 2007-02-06 2014-09-09 George Creasy Progesterone for the treatment or prevention of spontaneous preterm birth
US20080214512A1 (en) * 2007-03-01 2008-09-04 Christian Seitz Pharmaceutical preparation containing a gestagen, and kit and method for treating endometriosis using the preparation
CA2710293A1 (en) * 2007-12-20 2009-07-02 Teva Women's Health, Inc. Dosage regimens and pharmaceutical compositions and packages for emergency contraception
FR2947178B1 (fr) * 2009-06-29 2012-07-06 Effik Composition pharmaceutique a base de progesterone micronisee et ses utilisations
US10231976B2 (en) * 2010-02-08 2019-03-19 Prairie Pharmaceuticals LLC Methods for the use of progestogen as a glucocorticoid sensitizer
US20110262502A1 (en) * 2010-02-08 2011-10-27 Prairie Pharmaceuticals LLC Pulmonary delivery of 17-hydroxyprogesterone caproate (17-hpc)
US10987361B2 (en) 2010-02-08 2021-04-27 Shenzhen Evergreen Therapeutics Co., Ltd. Treating auto-immune and auto-inflammatory diseases
US10993879B2 (en) 2010-02-08 2021-05-04 Shenzhen Evergreen Therapeutics Co., Ltd. Pulmonary delivery of progestogen
US9375437B2 (en) 2010-06-18 2016-06-28 Lipocine Inc. Progesterone containing oral dosage forms and kits
US9084797B2 (en) * 2011-05-23 2015-07-21 Besins Healthcare Luxembourg Sarl Progesterone treatment for improving sleep quality
US8951996B2 (en) 2011-07-28 2015-02-10 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods
CA2854164C (en) * 2011-11-04 2021-04-13 Agile Therapeutics, Inc. Dermal delivery compositions and methods
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
ES2885523T3 (es) 2011-11-23 2021-12-14 Therapeuticsmd Inc Formulaciones y terapias de reposición hormonal de combinación naturales
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806697B2 (en) 2012-12-21 2020-10-20 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
US10537581B2 (en) 2012-12-21 2020-01-21 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
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 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
EP3122364A4 (de) * 2014-03-28 2017-10-25 TherapeuticsMD, Inc. Progesteronformulierungen
AU2015264003A1 (en) 2014-05-22 2016-11-17 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
WO2016018993A1 (en) 2014-07-29 2016-02-04 Therapeuticsmd, Inc. Transdermal cream
GB201505347D0 (en) * 2015-03-27 2015-05-13 Salupont Consulting Ltd Sterilisation of s-nitrosothiols
MX2017016823A (es) 2015-06-22 2018-03-12 Lipocine Inc Composiciones orales que contienen éster de 17- hydroxiprogesterona y métodos relacionados.
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
WO2017173071A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
US11633405B2 (en) 2020-02-07 2023-04-25 Therapeuticsmd, Inc. Steroid hormone pharmaceutical formulations

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WO2001030355A1 (fr) * 1999-10-25 2001-05-03 Laboratoire Theramex Medicament contraceptif a base d'un progestatif et d'un estrogene et son mode de preparation
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US6294192B1 (en) 1999-02-26 2001-09-25 Lipocine, Inc. Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents
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US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
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FR2818905A1 (fr) * 2000-12-28 2002-07-05 Cll Pharma Compositions pharmaceutiques colloidales micellaires renfermant un principe actif lipophile
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Also Published As

Publication number Publication date
EP1893182A2 (de) 2008-03-05
US8663681B2 (en) 2014-03-04
AU2006249349B2 (en) 2012-01-12
WO2006128057A2 (en) 2006-11-30
US20060275360A1 (en) 2006-12-07
ES2381495T3 (es) 2012-05-28
EP1893182B8 (de) 2012-04-04
EA200702627A1 (ru) 2008-06-30
EA015155B1 (ru) 2011-06-30
WO2006128057A3 (en) 2007-04-12
AU2006249349A1 (en) 2006-11-30
EP1893182B1 (de) 2012-02-01
CA2609192A1 (en) 2006-11-30

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