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Adhesive patch

A technology of patch and adhesive layer, which is applied in the direction of anti-inflammatory agents, non-central analgesics, medical preparations of non-active ingredients, etc., and can solve pain, insufficient skin adhesion, and decreased permeability of diclofenac, etc. pain reduction, excellent skin permeability, and excellent adhesion

Active Publication Date: 2014-08-06
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, if propylene glycol is used in the above patch, there are problems such as redness, erythema, rash, itching, painful skin symptoms, or pain when peeled off, and the adhesion to the skin is not good. full of such questions
In addition, if glycerin is used instead of the above-mentioned propylene glycol in order to reduce skin irritation, there is a problem that the skin permeability of diclofenac decreases.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] First, weigh 5.0 parts by mass of glycerin, 35.0 parts by mass of D-sorbitol aqueous solution (70 mass%), 10.0 parts by mass of butanediol (1,3-butanediol), 5.0 parts by mass of polyethylene glycol Glycol monooleate (the average addition mole number of oxyethylene groups: 6), 1.0 parts by mass of diclofenac sodium, 0.5 parts by mass of menthol, 7.0 parts by mass of water-soluble polymer 1 (mass of sodium polyacrylate: carboxyl group Sodium methylcellulose mass=5:2), 0.5 parts by mass of adhesion enhancer, 6.0 parts by mass of inorganic filler, 0.44 parts by mass of cross-linking agent, 0.25 parts by mass of pH regulator, 0.02 parts by mass of sodium sulfite , 0.02 parts by mass of dibutylhydroxytoluene, and 29.27 parts by mass of purified water were mixed to obtain an adhesive layer (paste layer) composition. Next, the obtained adhesive layer composition was adjusted to 1000 g / m 2 The method is in the non-woven fabric containing polyester fiber (head payment: 100g / m 2...

Embodiment 2~6

[0121] An adhesive patch (paste) was obtained in the same manner as in Example 1 except that the composition of the adhesive layer composition was set to the composition shown in Table 4, respectively. Table 4 shows the results of the skin penetration test (12 hours), the rolling ball adhesion test, and the time-dependent coloring evaluation test of the obtained patch, together with the composition of the adhesive layer composition. In addition, the water-soluble polymer 2 described in Table 4 contained sodium polyacrylate, sodium carboxymethylcellulose, gelatin, and hydroxypropylcellulose in this order at a mass ratio of 5:1.25:2:3.

[0122] [Table 4]

[0123]

[0124] From the results shown in Table 4, it can be clearly confirmed that in the patch containing a large amount of sodium sulfite (Example 2), and the patch containing sodium sulfite and sodium pyrosulfite or sodium bisulfite (Examples 3-4), especially It can suppress the discoloration of the adhesive layer.

Embodiment 7~19、 comparative example 18~19

[0126] An adhesive patch (paste) was obtained in the same manner as in Example 1 except that the composition of the adhesive layer composition was set to the compositions shown in Tables 5 to 6, respectively. The results of the skin penetration test (12 hours), the rolling ball tack test, and the shape retention evaluation test of the patches obtained in Examples 7 to 9 and Comparative Examples 18 to 19 were compared with the composition of the adhesive layer composition. They are shown in Table 5 together. In addition, the results of Example 2 are also shown in Table 5 together. Furthermore, the results of the rolling ball adhesion test on the patches obtained in Examples 10 to 19 are shown in Table 6 together with the composition of the adhesive layer composition.

[0127] [table 5]

[0128]

[0129] [Table 6]

[0130]

[0131] From the results shown in Table 5, it was clearly confirmed that in the patch (Comparative Example 18) in which the ratio of the mass of but...

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Abstract

An adhesive patch which is provided with a supporting body layer and an adhesive layer. This adhesive patch is characterized in that: the adhesive layer contains diclofenac or a pharmaceutically acceptable salt thereof, glycerol, butylene glycol and polyethylene glycol monooleate; and the mass ratio of the butylene glycol to the polyethylene glycol monooleate (namely, mass of butylene glycol:mass of polyethylene glycol monooleate) is from 1:1 to 4:1.

Description

technical field [0001] The present invention relates to adhesives. Background technique [0002] Diclofenac is a non-steroidal analgesic and anti-inflammatory drug, which is included in the pharmacopoeias of various countries in the world except the Japanese Pharmacopoeia. As preparations containing diclofenac sodium which is a salt of diclofenac, not only oral preparations such as lozenges and capsules are provided, but also external preparations such as gels, ointments, and patches are also provided in recent years, and are widely used for deformation Treatment of local diseases such as venereal joint disease and frozen shoulder. [0003] In addition, in such external preparations, attempts have been made to ensure stable release of diclofenac. For example, Japanese Patent Application Laid-Open No. 63-091318 (Patent Document 1) describes a combination of diclofenac sodium and 1,3-butanediene. Alcohol adhesives. Furthermore, Japanese Patent Application Laid-Open No. 6-56...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/196A61K9/70A61K47/02A61K47/10A61K47/34A61P29/00
CPCA61K9/7069A61K47/10A61K9/7061A61K47/02A61K31/196A61P29/00
Inventor 贵岛优古濑靖久義永隆明
Owner HISAMITSU PHARM CO INC