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Testosterone gels comprising propylene glycol as penetration enhancer

A technology of testosterone gel, which is applied in the field of testosterone gel containing penetration enhancer propylene glycol, which can solve problems such as liver toxicity

Active Publication Date: 2007-08-15
BESINS HEALTHCARE LUXEMBOURG (LU)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, there is a risk of hepatotoxicity as the liver metabolizes the agent, let alone first-pass metabolism

Method used

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  • Testosterone gels comprising propylene glycol as penetration enhancer
  • Testosterone gels comprising propylene glycol as penetration enhancer
  • Testosterone gels comprising propylene glycol as penetration enhancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0214] Using radioactive labels ( 14 C) Testosterone and liquid scintillation titration, transdermal release studies of testosterone gels on animal and human skin. These studies give kinetic parameters (release and flux after 24 hours). The following two aspects were studied:

[0215] - Physico-chemical studies (testosterone solubility and gel viscosity)

[0216] - Transdermal release (influence of testosterone concentration, gelling agent properties, presence of penetration enhancers)

[0217] Raw Materials and Methods

[0218] 1. Raw materials

[0219] chemicals

[0220] Testosterone (Fluka)

[0221] 14 C Testosterone (Amersham)

[0222] gelling agent

[0223] Carbopol(R) 934P (Carb.934P) (Polyplastic)

[0224] Carbopol(R) 980 (Carb. 980) (Lot 4419, Laboratoires Besins Iscovesco) Klucel(R)

[0225] Neutralizer

[0226] Triethanolamine (lot 4343, Laboratoires Besins Iscovesco)

[0227] penetration enhancer

[0228] Transcutanol (Gattefosse)

[0229] Oleic ...

Embodiment 2

[0315] Raw Materials and Methods

[0316] 1. Raw materials

[0317] [1, 2, 6, 7- 3 H] Testosterone (Amersham Laboratory): MW295, 1mCi / mL (37MBq / mL) ethanol solution; specific activity 99Ci / mmol (3.66TBq / mmol), ie 336mCi / mg (lot number t18).

[0318] Absolute Ethanol Carlo Erba Lot No. V4N051154N

[0319] Ingredients controlled by Besins Laboratories

[0320] Carbopol(R) 980 Batch No. 92010 / 4420

[0321] Carbopol® 934 Batch No. / 3898

[0322] Testosterone Lot No. 92039 / 4461

[0323] Isopropyl Myristate Batch No. 91169 / 5781

[0324] Triethanolamine Batch No. 9304020 / 5721

[0325] Propylene Glycol (PG)

[0326] Formulation applied to skin: (100 g final formulation weight)

[0327] Preparation number

testicles

hormone

gelling agent

none

water

Second

Alcohol

Neutralizer

propane two

Alcohol

Tetradecane

isopropyl acid

ester

1 (reference)

2.5

Carb.934:1.0

...

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Abstract

The present invention relates to testosterone-containing pharmaceutical compositions and gels, and to methods using the same.

Description

technical field [0001] The present invention relates to testosterone-containing pharmaceutical compositions and gels, and methods of their use. Background technique [0002] testosterone in men [0003] Testosterone, the main androgen circulating in men, is synthesized from cholesterol. About 500 million Leydig cells in the test secreted more than 95% of the 6-7mg testosterone produced per day. Two hormones produced by the pituitary gland, luteinizing hormone ("LH") and follicle-stimulating hormone ("FSH"), are required for the development and maintenance of testicular function and for negative regulation of testosterone production. Circulating testosterone is metabolized to various 17-ketosteroids by two different pathways. Testosterone can be metabolized by 5-alpha-reductase to dihydrotestosterone ("DHT") or to estradiol ("E2") by an aromatase complex. 98% of the testosterone circulating in the blood is bound to proteins. In males, about 40% bind to the high affinity ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K47/10A61K31/568
CPCA61K47/38A61K9/06A61K47/10A61K47/18A61K47/14A61K31/568A61K47/32A61P15/00A61P5/24
Inventor 多米尼克·萨林-德鲁安
Owner BESINS HEALTHCARE LUXEMBOURG (LU)