CA2721509A1 - Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications - Google Patents
Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications Download PDFInfo
- Publication number
- CA2721509A1 CA2721509A1 CA2721509A CA2721509A CA2721509A1 CA 2721509 A1 CA2721509 A1 CA 2721509A1 CA 2721509 A CA2721509 A CA 2721509A CA 2721509 A CA2721509 A CA 2721509A CA 2721509 A1 CA2721509 A1 CA 2721509A1
- Authority
- CA
- Canada
- Prior art keywords
- progesterone
- injectable
- aqueous suspension
- particles
- suspension
- 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.)
- Abandoned
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 claims abstract description 216
- 239000000186 progesterone Substances 0.000 title claims abstract description 108
- 229960003387 progesterone Drugs 0.000 title claims abstract description 108
- 238000000034 method Methods 0.000 title claims abstract description 28
- 230000001225 therapeutic effect Effects 0.000 title claims abstract description 13
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 12
- 239000007924 injection Substances 0.000 claims description 41
- 230000036470 plasma concentration Effects 0.000 claims description 39
- 238000002347 injection Methods 0.000 claims description 38
- 229940102213 injectable suspension Drugs 0.000 claims description 20
- 239000002245 particle Substances 0.000 claims description 15
- 239000007900 aqueous suspension Substances 0.000 claims description 14
- 201000000736 Amenorrhea Diseases 0.000 claims description 5
- 206010001928 Amenorrhoea Diseases 0.000 claims description 5
- 206010013908 Dysfunctional uterine bleeding Diseases 0.000 claims description 5
- 206010036618 Premenstrual syndrome Diseases 0.000 claims description 5
- 231100000540 amenorrhea Toxicity 0.000 claims description 5
- 230000029849 luteinization Effects 0.000 claims description 5
- 238000011282 treatment Methods 0.000 claims description 5
- 206010000242 Abortion threatened Diseases 0.000 claims description 4
- 201000009273 Endometriosis Diseases 0.000 claims description 4
- 206010020112 Hirsutism Diseases 0.000 claims description 4
- 208000006399 Premature Obstetric Labor Diseases 0.000 claims description 4
- 206010036600 Premature labour Diseases 0.000 claims description 4
- 208000005985 Threatened Abortion Diseases 0.000 claims description 4
- 206010000210 abortion Diseases 0.000 claims description 4
- 231100000176 abortion Toxicity 0.000 claims description 4
- 230000000295 complement effect Effects 0.000 claims description 4
- 239000013078 crystal Substances 0.000 claims description 4
- 201000006828 endometrial hyperplasia Diseases 0.000 claims description 4
- 230000000938 luteal effect Effects 0.000 claims description 4
- 208000026440 premature labor Diseases 0.000 claims description 4
- 230000002265 prevention Effects 0.000 claims description 4
- 230000002459 sustained effect Effects 0.000 claims 1
- 239000011859 microparticle Substances 0.000 description 13
- 238000002560 therapeutic procedure Methods 0.000 description 10
- 239000004005 microsphere Substances 0.000 description 9
- 230000003442 weekly effect Effects 0.000 description 4
- 230000002411 adverse Effects 0.000 description 3
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940088597 hormone Drugs 0.000 description 2
- 239000005556 hormone Substances 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 206010022998 Irritability Diseases 0.000 description 1
- 238000011443 conventional therapy Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000010224 hepatic metabolism Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229940126601 medicinal product Drugs 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 239000013081 microcrystal Substances 0.000 description 1
- 239000006201 parenteral dosage form Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000009291 secondary effect Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
-
- 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
- A61P15/12—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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/MX2008/000051 WO2009128692A1 (es) | 2008-04-14 | 2008-04-14 | Método y composición farmacéutica para lograr niveles plasmáticos de progesterona requeridos para diferentes indicaciones terapéuticas |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2721509A1 true CA2721509A1 (en) | 2009-10-22 |
Family
ID=41199287
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2721509A Abandoned CA2721509A1 (en) | 2008-04-14 | 2008-04-14 | Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20110104289A1 (enExample) |
| EP (1) | EP2272519A4 (enExample) |
| JP (1) | JP2011516606A (enExample) |
| CN (1) | CN102056611A (enExample) |
| BR (1) | BRPI0822165A2 (enExample) |
| CA (1) | CA2721509A1 (enExample) |
| IL (1) | IL208723A0 (enExample) |
| WO (1) | WO2009128692A1 (enExample) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| EP2782584B1 (en) | 2011-11-23 | 2021-06-09 | TherapeuticsMD, Inc. | Natural combination hormone replacement formulations and therapies |
| US10806697B2 (en) | 2012-12-21 | 2020-10-20 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| 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 |
| US20130338122A1 (en) | 2012-06-18 | 2013-12-19 | Therapeuticsmd, Inc. | Transdermal hormone replacement therapies |
| US11266661B2 (en) | 2012-12-21 | 2022-03-08 | 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 |
| 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 |
| 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 |
| AR100562A1 (es) | 2014-05-22 | 2016-10-12 | Therapeuticsmd Inc | Composición farmacéutica de estradiol y progesterona para terapia de reemplazo hormonal |
| KR20170040209A (ko) | 2014-07-29 | 2017-04-12 | 쎄러퓨틱스엠디, 인코퍼레이티드 | 경피 크림 |
| US10328087B2 (en) | 2015-07-23 | 2019-06-25 | Therapeuticsmd, Inc. | Formulations for solubilizing hormones |
| KR20180126582A (ko) | 2016-04-01 | 2018-11-27 | 쎄러퓨틱스엠디, 인코퍼레이티드 | 스테로이드 호르몬 약제학적 조성물 |
| WO2017173044A1 (en) | 2016-04-01 | 2017-10-05 | Therapeuticsmd Inc. | Steroid hormone compositions in medium chain oils |
| CA3080456A1 (en) * | 2017-10-30 | 2019-05-09 | Carmentix Pte. Ltd. | Biomarkers of preterm birth |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2663223B1 (fr) * | 1990-06-14 | 1994-12-02 | Af Aplicaciones Far Lab | Forme galenique parenterale. |
| FR2663224B1 (fr) | 1990-06-14 | 1995-01-20 | Applicationes Farmaceuticas Sa | Forme galenique parenterale. |
| JPH0474117A (ja) * | 1990-07-16 | 1992-03-09 | Kokuritsu Eisei Shikenjo | 新規なマイクロスフェア |
| US6287693B1 (en) * | 1998-02-25 | 2001-09-11 | John Claude Savoir | Stable shaped particles of crystalline organic compounds |
| US6544553B1 (en) * | 1999-12-28 | 2003-04-08 | Watson Pharmaceuticals, Inc. | Dosage forms and methods for oral delivery of progesterone |
| US7589082B2 (en) * | 2003-06-13 | 2009-09-15 | Skendi Finance Ltd | Pharmaceutical formulation for contraception and hormone-replacement therapy |
-
2008
- 2008-04-14 CN CN2008801294325A patent/CN102056611A/zh active Pending
- 2008-04-14 BR BRPI0822165-0A patent/BRPI0822165A2/pt not_active IP Right Cessation
- 2008-04-14 EP EP08741598A patent/EP2272519A4/en not_active Withdrawn
- 2008-04-14 CA CA2721509A patent/CA2721509A1/en not_active Abandoned
- 2008-04-14 US US12/937,779 patent/US20110104289A1/en not_active Abandoned
- 2008-04-14 WO PCT/MX2008/000051 patent/WO2009128692A1/es not_active Ceased
- 2008-04-14 JP JP2011504940A patent/JP2011516606A/ja active Pending
-
2010
- 2010-10-14 IL IL208723A patent/IL208723A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2272519A4 (en) | 2011-04-27 |
| WO2009128692A1 (es) | 2009-10-22 |
| BRPI0822165A2 (pt) | 2015-06-16 |
| IL208723A0 (en) | 2010-12-30 |
| US20110104289A1 (en) | 2011-05-05 |
| JP2011516606A (ja) | 2011-05-26 |
| CN102056611A (zh) | 2011-05-11 |
| EP2272519A1 (en) | 2011-01-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |
Effective date: 20140415 |