JP2011516606A - 様々な治療指標に必要な血漿プロゲステロン濃度を得るための方法および医薬組成物 - Google Patents
様々な治療指標に必要な血漿プロゲステロン濃度を得るための方法および医薬組成物 Download PDFInfo
- Publication number
- JP2011516606A JP2011516606A JP2011504940A JP2011504940A JP2011516606A JP 2011516606 A JP2011516606 A JP 2011516606A JP 2011504940 A JP2011504940 A JP 2011504940A JP 2011504940 A JP2011504940 A JP 2011504940A JP 2011516606 A JP2011516606 A JP 2011516606A
- Authority
- JP
- Japan
- Prior art keywords
- progesterone
- concentration
- injectable
- plasma
- particles
- 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.)
- Pending
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 212
- 239000000186 progesterone Substances 0.000 title claims abstract description 106
- 229960003387 progesterone Drugs 0.000 title claims abstract description 106
- 238000000034 method Methods 0.000 title claims abstract description 27
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 14
- 230000001225 therapeutic effect Effects 0.000 title abstract description 6
- 238000002347 injection Methods 0.000 claims description 48
- 239000007924 injection Substances 0.000 claims description 48
- 238000011282 treatment Methods 0.000 claims description 21
- 230000036470 plasma concentration Effects 0.000 claims description 16
- 239000002245 particle Substances 0.000 claims description 15
- 239000007900 aqueous suspension Substances 0.000 claims description 14
- 229940102213 injectable suspension Drugs 0.000 claims description 13
- 230000000938 luteal effect Effects 0.000 claims description 8
- 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
- 206010027514 Metrorrhagia Diseases 0.000 claims description 5
- 206010036618 Premenstrual syndrome Diseases 0.000 claims description 5
- 231100000540 amenorrhea Toxicity 0.000 claims description 5
- 208000008899 Habitual abortion Diseases 0.000 claims description 4
- 206010020112 Hirsutism Diseases 0.000 claims description 4
- 208000005107 Premature Birth Diseases 0.000 claims description 4
- 206010036590 Premature baby Diseases 0.000 claims description 4
- 230000004064 dysfunction Effects 0.000 claims description 4
- 201000006828 endometrial hyperplasia Diseases 0.000 claims description 4
- 201000009273 Endometriosis Diseases 0.000 claims description 3
- 239000013078 crystal Substances 0.000 claims description 3
- 230000002265 prevention Effects 0.000 claims description 3
- 230000002459 sustained effect Effects 0.000 claims description 2
- 208000034213 recurrent susceptibility to 1 pregnancy loss Diseases 0.000 claims 3
- 208000005985 Threatened Abortion Diseases 0.000 claims 2
- 208000004145 Endometritis Diseases 0.000 claims 1
- 206010051459 Imminent abortion Diseases 0.000 claims 1
- 239000004005 microsphere Substances 0.000 description 9
- 239000000725 suspension Substances 0.000 description 8
- 239000011859 microparticle Substances 0.000 description 7
- 239000010419 fine particle Substances 0.000 description 6
- 230000036962 time dependent Effects 0.000 description 5
- 238000013270 controlled release Methods 0.000 description 4
- 230000002411 adverse Effects 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000003442 weekly effect Effects 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 229940088597 hormone Drugs 0.000 description 2
- 239000005556 hormone Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 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
- 230000009610 hypersensitivity Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000029849 luteinization Effects 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 239000013081 microcrystal Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000006201 parenteral dosage form Substances 0.000 description 1
- 230000002688 persistence Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001850 reproductive effect Effects 0.000 description 1
- 230000009291 secondary effect Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- -1 supplementation Chemical compound 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 231100001274 therapeutic index Toxicity 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
Images
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 (2)
| Publication Number | Publication Date |
|---|---|
| JP2011516606A true JP2011516606A (ja) | 2011-05-26 |
| JP2011516606A5 JP2011516606A5 (enExample) | 2012-04-12 |
Family
ID=41199287
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011504940A Pending JP2011516606A (ja) | 2008-04-14 | 2008-04-14 | 様々な治療指標に必要な血漿プロゲステロン濃度を得るための方法および医薬組成物 |
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) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2021501343A (ja) * | 2017-10-30 | 2021-01-14 | カーメンティクス・プロプライエタリー・リミテッド | 早産のバイオマーカー |
Families Citing this family (17)
| 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 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0474117A (ja) * | 1990-07-16 | 1992-03-09 | Kokuritsu Eisei Shikenjo | 新規なマイクロスフェア |
| JPH05507694A (ja) * | 1990-06-14 | 1993-11-04 | アプリカシオネス ファルマシューティカス,ソシエダド アノニマ デ カピタル バリアブレ | 注射可能な医薬組成物 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2663224B1 (fr) | 1990-06-14 | 1995-01-20 | Applicationes Farmaceuticas Sa | Forme galenique parenterale. |
| 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
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH05507694A (ja) * | 1990-06-14 | 1993-11-04 | アプリカシオネス ファルマシューティカス,ソシエダド アノニマ デ カピタル バリアブレ | 注射可能な医薬組成物 |
| JPH0474117A (ja) * | 1990-07-16 | 1992-03-09 | Kokuritsu Eisei Shikenjo | 新規なマイクロスフェア |
Non-Patent Citations (1)
| Title |
|---|
| JPN6013011903; Acta Medica Grupo Angeles 6,1, 200803, 8-13 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2021501343A (ja) * | 2017-10-30 | 2021-01-14 | カーメンティクス・プロプライエタリー・リミテッド | 早産のバイオマーカー |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2272519A4 (en) | 2011-04-27 |
| CA2721509A1 (en) | 2009-10-22 |
| WO2009128692A1 (es) | 2009-10-22 |
| BRPI0822165A2 (pt) | 2015-06-16 |
| IL208723A0 (en) | 2010-12-30 |
| US20110104289A1 (en) | 2011-05-05 |
| CN102056611A (zh) | 2011-05-11 |
| EP2272519A1 (en) | 2011-01-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20110413 |
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| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20110413 |
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| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20120217 |
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| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20130319 |
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| A02 | Decision of refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20131210 |