ATE543489T1 - Orale dosierformen mit progesteron und verwendungs- und herstellungsverfahren dafür - Google Patents
Orale dosierformen mit progesteron und verwendungs- und herstellungsverfahren dafürInfo
- 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
Links
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000006186 oral dosage form Substances 0.000 title 1
- 229960003387 progesterone Drugs 0.000 title 1
- 239000000186 progesterone Substances 0.000 title 1
- 239000002552 dosage form Substances 0.000 abstract 6
- 239000002775 capsule Substances 0.000 abstract 1
- 239000007884 disintegrant Substances 0.000 abstract 1
- 239000008157 edible vegetable oil Substances 0.000 abstract 1
- 229960001207 micronized progesterone Drugs 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Biophysics (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Botany (AREA)
- Zoology (AREA)
- Diabetes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
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) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2531929T3 (es) * | 2006-12-20 | 2015-03-20 | Teva Women's Health, Inc. | Formas de dosificación solidas que se disgregan en la boca que comprenden progestina y métodos para hacer y usar las mismas |
| US8828981B2 (en) | 2007-02-06 | 2014-09-09 | George Creasy | Progesterone for the treatment or prevention of spontaneous preterm birth |
| AU2014202051C1 (en) * | 2007-02-06 | 2021-04-22 | Columbia Laboratories (Bermuda) Limited | Progesterone for the treatment of 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 |
| EA201070715A1 (ru) * | 2007-12-20 | 2011-02-28 | Тева Вимен'С Хелс, Инк. | Режимы дозирования, фармацевтические композиции и упаковки для экстренной контрацепции |
| FR2947178B1 (fr) * | 2009-06-29 | 2012-07-06 | Effik | Composition pharmaceutique a base de progesterone micronisee et ses utilisations |
| US10993879B2 (en) | 2010-02-08 | 2021-05-04 | Shenzhen Evergreen Therapeutics Co., Ltd. | Pulmonary delivery of progestogen |
| US20110262502A1 (en) * | 2010-02-08 | 2011-10-27 | Prairie Pharmaceuticals LLC | Pulmonary delivery of 17-hydroxyprogesterone caproate (17-hpc) |
| EP3689364A1 (de) * | 2010-02-08 | 2020-08-05 | Shenzhen Evergreen Therapeutics Co., Ltd. | Verfahren zur verwendung von progestogen als glucocorticoid-sensibilisierer |
| US10987361B2 (en) | 2010-02-08 | 2021-04-27 | Shenzhen Evergreen Therapeutics Co., Ltd. | Treating auto-immune and auto-inflammatory diseases |
| 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 |
| US9364487B2 (en) * | 2011-11-04 | 2016-06-14 | 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 |
| RS62297B1 (sr) | 2011-11-23 | 2021-09-30 | Therapeuticsmd Inc | Prirodne kombinovane hormonske supstitucione formulacije i terapije |
| US10806740B2 (en) | 2012-06-18 | 2020-10-20 | 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 |
| 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 |
| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | 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 |
| 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 |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | 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 |
| CA2942568A1 (en) * | 2014-03-28 | 2015-10-01 | Therapeuticsmd, Inc. | Progesterone formulations |
| RU2016143081A (ru) | 2014-05-22 | 2018-06-26 | Терапьютиксмд, Инк. | Натуральные комбинированные гормонозаместительные составы и терапии |
| EP3174542A4 (de) | 2014-07-29 | 2018-01-03 | TherapeuticsMD, Inc. | Transdermale creme |
| GB201505347D0 (en) * | 2015-03-27 | 2015-05-13 | Salupont Consulting Ltd | Sterilisation of s-nitrosothiols |
| ES3005883T3 (en) | 2015-06-22 | 2025-03-17 | Lipocine Inc | 17-hydroxyprogesterone ester-containing oral compositions and related methods |
| US10328087B2 (en) | 2015-07-23 | 2019-06-25 | Therapeuticsmd, Inc. | Formulations for solubilizing hormones |
| US9931349B2 (en) | 2016-04-01 | 2018-04-03 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical composition |
| US10286077B2 (en) | 2016-04-01 | 2019-05-14 | Therapeuticsmd, Inc. | Steroid hormone compositions in medium chain oils |
| US11633405B2 (en) | 2020-02-07 | 2023-04-25 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical formulations |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2408345A1 (fr) * | 1976-11-30 | 1979-06-08 | Besins Jean Louis | Nouvelle composition a action anti-conceptionnelle |
| US4439432A (en) * | 1982-03-22 | 1984-03-27 | Peat Raymond F | Treatment of progesterone deficiency and related conditions with a stable composition of progesterone and tocopherols |
| US4963540A (en) * | 1986-04-16 | 1990-10-16 | Maxson Wayne S | Method for treatment of premenstrual syndrome |
| US5140021A (en) * | 1986-04-16 | 1992-08-18 | Genesis Systems Corporation | Method and dosage form for treatment of premenstrual syndrome |
| US4927816A (en) * | 1987-08-20 | 1990-05-22 | Ester George C | Formulae and methods for sublingual ingestion of natural progesterone |
| US4900734A (en) * | 1987-08-27 | 1990-02-13 | Maxson Wayne S | Novel pharmaceutical composition containing estradiol and progesterone for oral administration |
| JPH07501259A (ja) * | 1990-06-01 | 1995-02-09 | リサーチ コーポレイション テクノロジーズ，インコーポレイテッド | 自己乳化型ガラス |
| SE9301171D0 (sv) * | 1993-04-07 | 1993-04-07 | Ab Astra | Pharmaceutical composition containing lipophilic drugs |
| GB9405304D0 (en) * | 1994-03-16 | 1994-04-27 | Scherer Ltd R P | Delivery systems for hydrophobic drugs |
| US5633011A (en) * | 1994-08-04 | 1997-05-27 | Alza Corporation | Progesterone replacement therapy |
| WO1997004752A1 (en) * | 1995-07-26 | 1997-02-13 | Duramed Pharmaceuticals, Inc. | Pharmaceutical compositions of conjugated estrogens and methods for their use |
| DE69713948D1 (de) * | 1996-04-23 | 2002-08-22 | Janssen Pharmaceutica Nv | Rasch-freisetzende pH-unabhängige feste Dosisformen enthaltend Cisaprid |
| 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 |
| AU5806998A (en) * | 1996-12-31 | 1998-07-31 | Inhale Therapeutic Systems | Processes for spray drying solutions of hydrophobic drugs with hydrophilic excipients and compositions prepared by such processes |
| FR2772617B1 (fr) * | 1997-12-19 | 2001-03-09 | Besins Iscovesco Lab | Comprime de progesterone et son procede de preparation |
| US6294192B1 (en) * | 1999-02-26 | 2001-09-25 | Lipocine, Inc. | Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| US6267985B1 (en) * | 1999-06-30 | 2001-07-31 | Lipocine Inc. | Clear oil-containing pharmaceutical compositions |
| US6787531B1 (en) * | 1999-08-31 | 2004-09-07 | Schering Ag | Pharmaceutical composition for use as a contraceptive |
| US6544553B1 (en) * | 1999-12-28 | 2003-04-08 | Watson Pharmaceuticals, Inc. | Dosage forms and methods for oral delivery of progesterone |
| FR2818905A1 (fr) * | 2000-12-28 | 2002-07-05 | Cll Pharma | Compositions pharmaceutiques colloidales micellaires renfermant un principe actif lipophile |
| FR2821555B1 (fr) * | 2001-03-01 | 2003-05-16 | Besins Int Lab | Progestatif co-micronise avec un tensioactif, composition pharmaceutique le comprenant, leurs procedes de fabrication et leurs utilisations |
| CA2446849A1 (en) * | 2001-05-16 | 2002-11-21 | Endeavor Pharmaceuticals | Treatment of conditions relating to hormone deficiencies by administration of progestins |
| FR2832065B1 (fr) * | 2001-11-13 | 2004-11-05 | Besins Int Belgique | Composition pharmaceutique a base de progesterone micronisee son procede de preparation et ses utilisations |
| US20030191096A1 (en) * | 2002-04-03 | 2003-10-09 | Leonard Thomas W. | Method of hormonal therapy |
| FR2851918B1 (fr) * | 2003-03-06 | 2006-06-16 | Poudre impregnee ameliorant la biodisponibilite et/ou la solubilite et procede de fabrication | |
| WO2004091535A2 (en) * | 2003-04-11 | 2004-10-28 | Barr Laboratories, Inc. | Methods of administering estrogens and progestins |
| US20050008704A1 (en) * | 2003-07-11 | 2005-01-13 | Ray Anup Kumar | Pharmaceutical composition for solubility enhancement of hydrophobic drugs |
-
2006
- 2006-05-26 US US11/441,447 patent/US8663681B2/en not_active Expired - Fee Related
- 2006-05-26 WO PCT/US2006/020609 patent/WO2006128057A2/en not_active Ceased
- 2006-05-26 EP EP06771398A patent/EP1893182B8/de active Active
- 2006-05-26 ES ES06771398T patent/ES2381495T3/es active Active
- 2006-05-26 AT AT06771398T patent/ATE543489T1/de active
- 2006-05-26 AU AU2006249349A patent/AU2006249349B2/en not_active Ceased
- 2006-05-26 EA EA200702627A patent/EA015155B1/ru not_active IP Right Cessation
- 2006-05-26 CA CA002609192A patent/CA2609192A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP1893182A2 (de) | 2008-03-05 |
| WO2006128057A2 (en) | 2006-11-30 |
| EA015155B1 (ru) | 2011-06-30 |
| AU2006249349A1 (en) | 2006-11-30 |
| EP1893182B1 (de) | 2012-02-01 |
| CA2609192A1 (en) | 2006-11-30 |
| ES2381495T3 (es) | 2012-05-28 |
| EP1893182B8 (de) | 2012-04-04 |
| US20060275360A1 (en) | 2006-12-07 |
| EA200702627A1 (ru) | 2008-06-30 |
| WO2006128057A3 (en) | 2007-04-12 |
| US8663681B2 (en) | 2014-03-04 |
| AU2006249349B2 (en) | 2012-01-12 |
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