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Hydrogel-patch-type pharmaceutical composition for transdermal administration

A hydrogel patch and composition technology, applied in medical preparations containing active ingredients, medical science, pharmaceutical formulations, etc., can solve the problem of long cross-linking time, difficulty in adjusting adhesion and gel strength, and difficulty in application Problems such as the preparation process, to achieve the effects of low viscosity, excellent formulation and operability, and excellent transdermal permeability

Pending Publication Date: 2020-09-01
DAE HWA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the cross-linking by metal complex ionic bonds generally used in commercialized and commercially available existing hydrogel formulations takes a long time of about one week to three weeks to achieve complete cross-linking, and there is a problem that it is difficult to adjust the adhesion. Force and Gel Strength Questions
Cross-linking by repeated freezing / thawing also has the disadvantage that the cross-linking time is very long, it is difficult to apply to the manufacturing process, and the unit price of the product increases
In addition, crosslinking using aldehydes has toxicity problems due to the residue of the crosslinking agent (aldehydes) and unreacted initiator

Method used

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  • Hydrogel-patch-type pharmaceutical composition for transdermal administration
  • Hydrogel-patch-type pharmaceutical composition for transdermal administration
  • Hydrogel-patch-type pharmaceutical composition for transdermal administration

Examples

Experimental program
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Effect test

preparation example Construction

[0038] The invention also provides a preparation method of the pharmaceutical composition in the form of hydrogel patch. For example, the present invention provides a method for preparing a pharmaceutical composition in the form of a hydrogel patch comprising the steps of: (a) dissolving an active pharmaceutical ingredient or an active pharmaceutical ingredient and a penetration enhancer, optionally together with a fragrance, in co-solvent, thereby preparing the first solution; (b) acid, chelating agent and viscosity modifier dissolved in water, thereby preparing the second solution; (c) partially neutralized polyacrylic acid, cross-linking agent and anti-leakage agent dispersing in a dispersant to prepare a dispersion; and (d) mixing the first solution, the second solution and the dispersion to form a hydrogel.

[0039] In the preparation method of the present invention, the step (a), step (b) and step (c) do not have to be performed sequentially, which is obvious to those sk...

Embodiment 1 to Embodiment 6

[0042] Example 1 to Example 6: Preparation of hydrogel and patch containing the hydrogel

[0043] Hydrogels were prepared according to the ingredients and contents in Table 1 below. The content in Table 1 represents the weight % of each component in the hydrogel. Add flurbiprofen and L-menthol to co-solvents [propylene glycol, polysorbate 80 and / or sorbitan monooleate (Span 80 TM (Span80 TM))] and stirred at 50-55°C to dissolve (Solution A). Tartaric acid, sodium edetate and a viscosity modifier [sodium carboxymethylcellulose and / or hydroxypropylcellulose] were added to purified water and stirred at about 40°C to dissolve (solution B). Partially neutralized polyacrylic acid (Viscomate NP-800 TM , Showa Denko Co., Ltd.), cross-linking agent [aluminum hydroxide and / or aluminum dihydroxyglycinate] and anti-leakage agent [polyacrylic acid and / or kaolin] dispersed in dispersant [glycerin and / or polyethylene glycol] (Dispersion C). The solution A and solution B were mixed, and...

Embodiment 7 to Embodiment 11

[0047] Example 7 to Example 11: Preparation of hydrogel and patch containing the hydrogel

[0048] Hydrogels were prepared according to the ingredients and contents in Table 2 below. The contents in Table 2 represent the weight % of each component in the hydrogel. Add loxoprofen sodium hydrate, isostearyl glyceryl ether and L-menthol to co-solvent [propylene glycol, polysorbate 80 and / or sorbitan monooleate (Span 80 TM (Span80 TM ))] and stirred at 50-55°C to dissolve (Solution A). Acid [tartaric acid or acetic acid], sodium edetate and viscosity modifier [sodium carboxymethylcellulose and / or gelatin] were added to purified water and stirred at about 40°C to dissolve (solution B). Partially neutralized polyacrylic acid (Viscomate NP-800 TM , Showa Denko Co., Ltd.), cross-linking agent [aluminum hydroxide and / or aluminum dihydroxyglycinate] and anti-leakage agent [polyacrylic acid and / or kaolin] dispersed in dispersant [glycerin and / or polyethylene glycol] (Dispersion C). ...

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Abstract

The present invention provides a hydrogel-patch-type pharmaceutical composition comprising: a pharmaceutical active ingredient; a polyacrylic acid partial neutralizer as a gel former; a combination ofacid and a cross-linking agent selected from the group consisting of aluminum salts, magnesium salts, and calcium salts; and 5-20 wt% of water.

Description

technical field [0001] The present invention relates to a pharmaceutical composition for transdermal administration in the form of a hydrogel patch. In more detail, the present invention relates to a pharmaceutical composition in the form of a hydrogel patch comprising a specific gel forming agent and a crosslinking agent and comprising 5-20% by weight of water. Background technique [0002] Patches (commonly referred to as "patches") are classified into cataplasms in the form of wet compresses containing moisture and plasters which are solid preparations. Due to the characteristics of the preparation, besides the adhesive layer containing the drug, the cataplasm also contains a separate adhesive cloth with low stretching rate. Plasters containing acrylic resins and the like are formulations that do not contain moisture, and thus have a disadvantage of exhibiting skin irritation compared with cataplasms. In contrast, cataplasms are less irritating to the skin than plasters...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/192A61L26/00
CPCA61K9/70A61K31/192A61L26/00A61K9/703A61L26/008A61L26/0014A61L26/0004
Inventor 金明珍李智演宋寅范李仁铉张准熙
Owner DAE HWA PHARMA