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Period effect percutaneous patch of self viscosity elastic body substrate containing testosterone and preparation method thereof

An elastomer and self-adhesive technology, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as poor compliance, large drug loading, and increased costs. Achieve the effects of avoiding aging and oxidation, good adhesion, and reducing heating time

Active Publication Date: 2014-01-29
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the increase of the content of the main drug will often cause other problems, such as drug precipitation and crystallization during storage, waste of raw material drug due to large drug loading, increased cost, and drug residue after use of the patch, etc.
[0006] The currently marketed testosterone transdermal drug delivery system products mainly include testosterone patch, testosterone gel and testosterone spray, all of which are administered once a day, which is inconvenient for patients and poor in compliance

Method used

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  • Period effect percutaneous patch of self viscosity elastic body substrate containing testosterone and preparation method thereof
  • Period effect percutaneous patch of self viscosity elastic body substrate containing testosterone and preparation method thereof
  • Period effect percutaneous patch of self viscosity elastic body substrate containing testosterone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Preparation of lipophilic elastomer matrix with self-adhesive properties:

[0056] Take 100g of styrene-isoprene-styrene triblock copolymer (SIS), 140g of hydrogenated petroleum resin, 80g of naphthenic oil, 10g of isopropyl myristate, 5g of polyethylene glycol, N-methyl Pyrrolidone 15g, polyvinylpyrrolidone 10g, zinc oxide 10g, dibutylhydroxytoluene 2g. Heat SIS, naphthenic oil, isopropyl myristate, polyethylene glycol, N-methylpyrrolidone and dibutylhydroxytoluene to 160°C under nitrogen protection, and adjust the temperature to 100°C~ 120°C, add hydrogenated petroleum resin, polyvinylpyrrolidone and zinc oxide, continue heating and stirring for 20 minutes until a uniform and transparent colloid is formed, pour it out while it is hot, and cool it down.

[0057] It was determined that the melting point of the prepared lipophilic elastomer matrix with self-adhesive properties was 87°C.

Embodiment 2

[0059] Preparation of lipophilic elastomer matrix with self-adhesive properties:

[0060] Take 100g of styrene-isoprene-styrene triblock copolymer (SIS), 60g each of hydrogenated petroleum resin and hydrogenated rosin resin, 50g each of liquid paraffin and polybutene, 20g of diethyl phthalate, Polyethylene glycol 10g, lauryl lactate 10g, 2-ethylhexyl acrylate 20g, zinc oxide 10g, dibutylhydroxytoluene 5g. Heat SIS, liquid paraffin, polybutene, diethyl phthalate, polyethylene glycol, lauryl lactate and dibutyl hydroxytoluene to 180°C under nitrogen protection, and adjust the temperature after melting the components To 100℃~120℃, add hydrogenated petroleum resin, hydrogenated rosin resin, 2-ethylhexyl acrylate and zinc oxide, continue heating and stirring for 20 minutes until a uniform transparent colloid is formed, pour it out while it is hot, and cool it down.

[0061] It was determined that the melting point of the prepared lipophilic elastomer matrix with self-adhesive prop...

Embodiment 3

[0063] Preparation of a weekly transdermal composition containing testosterone:

[0064] [Prescription] (based on 1000 tablets)

[0065] Take 100g of styrene-isoprene-styrene triblock copolymer (SIS), 80g of hydrogenated petroleum resin, 40g of hydrogenated rosin resin, 60g of liquid paraffin, 40g of naphthenic oil, 10g of isopropyl myristate, poly 10g of ethylene glycol, 10g of N-methylpyrrolidone, 10g of methyl methacrylate, 5g of polyvinylpyrrolidone, 5g of zinc oxide, and 2g of dibutylhydroxytoluene.

[0066] Heat SIS, liquid paraffin, naphthenic oil, isopropyl myristate, polyethylene glycol, N-methylpyrrolidone and dibutyl hydroxytoluene to 160°C-180°C under nitrogen protection, after melting the components Adjust the temperature to 100°C-120°C, add hydrogenated petroleum resin, hydrogenated rosin resin, polyvinylpyrrolidone, methyl methacrylate and zinc oxide, continue heating under nitrogen protection until all components are stirred evenly; adjust the temperature to 7...

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Abstract

The invention discloses a period effect percutaneous patch of a self viscosity elastic body substrate covering and bearing testosterone and a preparation method thereof. The period effect percutaneous patch comprises a support layer, a medicine taking self viscosity elastic body substrate layer and a separation layer. The support layer is covered on one side of the medicine taking self viscosity elastic body substrate layer, and the separation layer is covered on the other side of the medicine taking self viscosity elastic body substrate layer. The period effect percutaneous patch adopts the lipotropy elastic body substrate with the low melting point to contain the testosterone, and a stable and effective testosterone blood concentration is maintained in 7 days. The patch is excellent in medicine skin penetrating performance, good in adhering performance, high in medicine loading rate, good in air permeability and free of residue when being stripped from the skin. A preparation process of the period effect percutaneous patch of the testosterone uses no machine solvent and is environment-friendly, coating is carried out in a melting state, and the preparation process has the advantages of being high in coating speed, high in production efficiency and low in cost.

Description

technical field [0001] The invention relates to a weekly-effect transdermal patch containing testosterone self-adhesive elastomer matrix and a preparation method thereof. Background technique [0002] Testosterone is an androgen, and it is mainly used to treat complications such as hypogonadism in males and masculinization disorders of secondary sexual characteristics caused by excessive androgen secretion. Due to the existence of the liver first-pass effect, oral administration of testosterone is ineffective and its bioavailability is extremely low; although injection administration avoids the first-pass effect, it will cause the peak-valley effect of testosterone concentration in the body. [0003] Therefore, seeking a preparation suitable for testosterone is a topic of great concern to people. [0004] U.S. FDA approves the testosterone (testosterone) transdermal patch (trade name: ) listed, It is a reservoir-type transdermal patch. Compared with the drug-in-adhesive...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/568A61K9/70A61K47/32A61K47/34A61K47/38A61K47/44A61P5/26
Inventor 马建芳罗华菲王浩侯惠民武余波朱壮志陈纯
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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