Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications

A technology of plasma and plasma concentration, applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve problems such as progesterone and progesterone not reached

Inactive Publication Date: 2011-05-11
POSI VISIONARY SOLUTIONS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Pharmaceutical compositions known hitherto have not achieved progesterone plasma concentrations suitable for maintenance of progesterone-needing treatments, in particular those described on page 2, during more than one day with a single dose

Method used

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  • Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications
  • Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications
  • Method and pharmaceutical composition for obtaining the plasmatic progesterone levels required for different therapeutic indications

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Single 100 mg injection of progesterone spherical microparticles in injectable suspension.

[0035] A single injection of 100 mg of progesterone spherical microparticles in the form of an injectable aqueous suspension was administered to 12 postmenopausal women. Plasma levels obtained at figure 1 , where it was observed that progesterone plasma concentrations were maintained for up to 7 days at levels appropriate for several treatments requiring said progesterone concentrations.

Embodiment 2

[0037] A single 200 mg injection of progesterone spherical microparticles in injectable suspension.

[0038] A single injection of 200 mg of progesterone spherical microparticles in the form of an injectable aqueous suspension was administered to 12 postmenopausal women. Plasma levels obtained at figure 2 , where it was observed that progesterone plasma concentrations were maintained for up to 7 days at levels appropriate for several treatments requiring said progesterone concentrations and described on page 2.

Embodiment 3

[0040] Repeated 200 mg injections of progesterone spherical microparticles in injectable suspension.

[0041] Four repeated injections of 200 mg of progesterone spherical microparticles were administered as an injectable aqueous suspension to 15 postmenopausal women. Plasma levels obtained at image 3 , where progesterone plasma concentrations were observed to be maintained for up to 7 days at levels appropriate for several treatments requiring said progesterone concentrations and described on page 2.

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Abstract

The invention relates to the development of a method and pharmaceutical compositions for obtaining plasmatic progesterone levels in humans and for maintaining a plasmatic progesterone concentration between 42 and 3.5 ng / mL for eight days as well as maximum plasmatic concentrations (Cmax) between 12 and 42 ng / mL, sufficient for use in different therapeutic options that require said progesterone concentrations.

Description

field of invention [0001] The present invention relates to be used for obtaining and keep the progesterone plasma level in the human body to continue 8 days between 42ng / mL and 3.5ng / mL and the maximum plasma concentration (Cmax) between 12ng / mL and 42ng / mL, enough to be used in Several methods of treating symptoms and designs of pharmaceutical compositions requiring such progesterone concentrations. technical field Background of the invention [0002] Although many pharmaceutical compositions exist in the art for the delivery of drugs in a controlled fashion and more specifically for the provision of hormones; in each case there are some significant disadvantages. For example, it has been reported that progesterone suffers from general hepatic metabolic disadvantages due to the first-pass effect when administered orally; metabolites formed therein may have secondary effects in addition to limited progesterone bioavailability by this means . Orally administered treatment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/57A61K9/16A61P15/12A61P15/06
CPCA61K9/0019A61K31/57A61P15/00A61P15/04A61P15/06A61P15/12A61P15/18
Inventor 约翰克劳德·萨瓦尔维勒伯夫奥雷利奥·德盖维斯洛佩斯莉娜胡安拉蒙·马丁内斯德莱昂
Owner POSI VISIONARY SOLUTIONS
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