AR099872A1 - PROGESTERONE FORMULATIONS - Google Patents
PROGESTERONE FORMULATIONSInfo
- Publication number
- AR099872A1 AR099872A1 ARP150100920A ARP150100920A AR099872A1 AR 099872 A1 AR099872 A1 AR 099872A1 AR P150100920 A ARP150100920 A AR P150100920A AR P150100920 A ARP150100920 A AR P150100920A AR 099872 A1 AR099872 A1 AR 099872A1
- Authority
- AR
- Argentina
- Prior art keywords
- progesterone
- subject
- need
- amount
- auc0
- Prior art date
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
- A61K9/48—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
- 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
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
-
- 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
- A61P5/34—Gestagens
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Reproductive Health (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Abstract
Formulaciones de progesterona, métodos para usar estas formulaciones y sus parámetros farmacocinéticos relacionados. Las formulaciones descritas en la presente descripción permiten una reducen en la cantidad de progesterona administrada a un paciente en necesidad de esta, mientras proporciona aún los beneficios de una cantidad mayor de dosis. Reivindicación 1: Una composición farmacéutica para administrar progesterona a sujetos en necesidad de esta, la composición comprende una cantidad de progesterona y uno o más agentes solubilizantes, en donde después de la administración al sujeto en necesidad de esta, la composición produce al menos uno de los siguientes parámetros farmacocinéticos en el sujeto: a) un AUC₀₋ₜ en (ng/ml)*h de aproximadamente 5 a aproximadamente 500; b) un AUC₀₋¥ en (ng/ml)*h de aproximadamente 5 a aproximadamente 500; o c) una Cₘₐˣ en ng/ml de aproximadamente 3 a aproximadamente 350; en donde la cantidad de progesterona es menor que 200 mg. Reivindicación 10: Una composición farmacéutica para administrar progesterona a un sujeto en necesidad de esta, la composición comprende una cantidad de progesterona, uno o más agentes solubilizantes, y un surfactante no iónico seleccionado del grupo que consiste en Iauroil macrogol-32 glicéridos EP (Gelucire 44/11), Iauroil polioxil-32 gliceridos (Gelucire 44/14), y caprilocaproil macrogol-8 gicéridos EP; en donde después de la administración al sujeto en necesidad de esta, la composición produce al menos uno de los siguientes parámetros farmacocinéticos en el sujeto: a) un AUC₀₋ₜ en (ng/mI)*h de aproximadamente 5 a aproximadamente 500; b) un AUC₀₋¥ en (ng/ml)*h de aproximadamente 5 a aproximadamente 500; o c) una Cₘₐˣ en ng/ml de aproximadamente 3 a aproximadamente 350.Progesterone formulations, methods for using these formulations and their related pharmacokinetic parameters. The formulations described in the present description allow a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger amount of dose. Claim 1: A pharmaceutical composition for administering progesterone to subjects in need thereof, the composition comprises an amount of progesterone and one or more solubilizing agents, wherein after administration to the subject in need thereof, the composition produces at least one of the following pharmacokinetic parameters in the subject: a) an AUC₀₋ₜ in (ng / ml) * h of about 5 to about 500; b) an AUC₀₋ ¥ in (ng / ml) * h of approximately 5 to approximately 500; or c) a Cₘₐˣ in ng / ml of about 3 to about 350; where the amount of progesterone is less than 200 mg. Claim 10: A pharmaceutical composition for administering progesterone to a subject in need thereof, the composition comprises an amount of progesterone, one or more solubilizing agents, and a non-ionic surfactant selected from the group consisting of Iauroyl macrogol-32 glycerides EP (Gelucire 44/11), Iauroyl polyoxyl-32 glycerides (Gelucire 44/14), and caprilocaproyl macrogol-8 glycerides EP; wherein after administration to the subject in need thereof, the composition produces at least one of the following pharmacokinetic parameters in the subject: a) an AUC₀₋ₜ in (ng / ml) * h of about 5 to about 500; b) an AUC₀₋ ¥ in (ng / ml) * h of approximately 5 to approximately 500; or c) a Cₘₐˣ in ng / ml of about 3 to about 350.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461972068P | 2014-03-28 | 2014-03-28 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR099872A1 true AR099872A1 (en) | 2016-08-24 |
Family
ID=54196452
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP150100920A AR099872A1 (en) | 2014-03-28 | 2015-03-27 | PROGESTERONE FORMULATIONS |
Country Status (10)
Country | Link |
---|---|
EP (1) | EP3122364A4 (en) |
JP (2) | JP2017509630A (en) |
KR (1) | KR20160137597A (en) |
AR (1) | AR099872A1 (en) |
AU (1) | AU2015237243A1 (en) |
CA (1) | CA2942568A1 (en) |
IL (1) | IL247828A0 (en) |
MX (1) | MX2016011706A (en) |
RU (1) | RU2016136666A (en) |
WO (1) | WO2015148952A1 (en) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2020081726A1 (en) * | 2018-10-17 | 2020-04-23 | Stadler Sarah Sheehan | Methods of treating menopausal symptoms using low dose progesterone |
CN112336699A (en) * | 2019-08-09 | 2021-02-09 | 南京科宁检测科技有限公司 | Progesterone vaginal slow-release soft capsule and its preparation method |
US20220105107A1 (en) * | 2020-10-01 | 2022-04-07 | Michael Liguori | Bioidentical progesterone cream infused with nanoemulsified cbd |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
US7374779B2 (en) * | 1999-02-26 | 2008-05-20 | Lipocine, Inc. | Pharmaceutical formulations and systems for improved absorption and multistage release of active agents |
MXPA03000720A (en) * | 2000-07-24 | 2004-11-01 | Upjohn Co | Self-emulsifying drug delivery systems for extremely water-insoluble, lipophilic drugs. |
AU2002242339A1 (en) * | 2002-03-14 | 2003-09-29 | Watson Pharmaceuticals, Inc. | Progesterone oral drug delivery system |
AU2006249349B2 (en) * | 2005-05-26 | 2012-01-12 | Teva Women's Health, Inc. | Oral dosage forms comprising progesterone and methods of making and using the same |
US20110312928A1 (en) * | 2010-06-18 | 2011-12-22 | Lipocine Inc. | Progesterone Containing Oral Dosage Forms and Related Methods |
US20110312927A1 (en) * | 2010-06-18 | 2011-12-22 | Satish Kumar Nachaegari | Progesterone Containing Oral Dosage Forms and Related Methods |
US9301920B2 (en) * | 2012-06-18 | 2016-04-05 | 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 |
-
2015
- 2015-03-27 EP EP15768772.4A patent/EP3122364A4/en not_active Withdrawn
- 2015-03-27 JP JP2016557059A patent/JP2017509630A/en active Pending
- 2015-03-27 CA CA2942568A patent/CA2942568A1/en not_active Abandoned
- 2015-03-27 KR KR1020167029519A patent/KR20160137597A/en unknown
- 2015-03-27 WO PCT/US2015/023041 patent/WO2015148952A1/en active Application Filing
- 2015-03-27 AR ARP150100920A patent/AR099872A1/en unknown
- 2015-03-27 MX MX2016011706A patent/MX2016011706A/en unknown
- 2015-03-27 AU AU2015237243A patent/AU2015237243A1/en not_active Abandoned
- 2015-03-27 RU RU2016136666A patent/RU2016136666A/en not_active Application Discontinuation
-
2016
- 2016-09-14 IL IL247828A patent/IL247828A0/en unknown
-
2019
- 2019-07-05 JP JP2019126362A patent/JP2019206540A/en active Pending
Also Published As
Publication number | Publication date |
---|---|
EP3122364A1 (en) | 2017-02-01 |
IL247828A0 (en) | 2016-11-30 |
CA2942568A1 (en) | 2015-10-01 |
MX2016011706A (en) | 2017-05-01 |
EP3122364A4 (en) | 2017-10-25 |
WO2015148952A1 (en) | 2015-10-01 |
RU2016136666A (en) | 2018-05-03 |
JP2017509630A (en) | 2017-04-06 |
KR20160137597A (en) | 2016-11-30 |
JP2019206540A (en) | 2019-12-05 |
AU2015237243A1 (en) | 2016-09-29 |
RU2016136666A3 (en) | 2018-11-07 |
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Legal Events
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FB | Suspension of granting procedure |