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AR099872A1 - PROGESTERONE FORMULATIONS - Google Patents

PROGESTERONE FORMULATIONS

Info

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
Application number
ARP150100920A
Other languages
Spanish (es)
Inventor
Persicaner Peter
Amadio Julia
Cacace Janice
Thorsteinsson Thorsteinn
Sancilio Frederick
Bernick Brian
Original Assignee
Therapeuticsmd 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 Therapeuticsmd Inc filed Critical Therapeuticsmd Inc
Publication of AR099872A1 publication Critical patent/AR099872A1/en

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.

ARP150100920A 2014-03-28 2015-03-27 PROGESTERONE FORMULATIONS AR099872A1 (en)

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210386757A1 (en) * 2018-10-17 2021-12-16 Sarah S. Stadler 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)

* Cited by examiner, † Cited by third party
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
EP1303261B1 (en) * 2000-07-24 2005-03-09 Pharmacia & Upjohn Company Self-emulsifying drug delivery systems for extremely water-insoluble, lipophilic drugs
CN1622810A (en) * 2002-03-14 2005-06-01 华生制药公司 Progesterone oral drug delivery system
WO2006128057A2 (en) * 2005-05-26 2006-11-30 Duramed Pharmaceuticals, 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

Also Published As

Publication number Publication date
IL247828A0 (en) 2016-11-30
CA2942568A1 (en) 2015-10-01
JP2017509630A (en) 2017-04-06
EP3122364A4 (en) 2017-10-25
RU2016136666A3 (en) 2018-11-07
EP3122364A1 (en) 2017-02-01
JP2019206540A (en) 2019-12-05
MX2016011706A (en) 2017-05-01
RU2016136666A (en) 2018-05-03
WO2015148952A1 (en) 2015-10-01
KR20160137597A (en) 2016-11-30
AU2015237243A1 (en) 2016-09-29

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