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Method for producing patch, patch and package

A manufacturing method and patch technology, applied in the field of patch manufacturing method, patch and packaging, can solve the problem of insufficient skin permeability of ropinirole, insufficient stability of ropinirole over time, etc. problem, to achieve the effect of inhibiting crystal growth and maintaining it for a long time

Active Publication Date: 2014-11-12
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the patches described in the above-mentioned Patent Documents 2 to 4, the skin permeability of ropinirole is not enough, and there is a problem that it is difficult to maintain the plasma concentration of ropinirole at a sufficiently high level.
Furthermore, in the patches described in Patent Documents 2 to 4, there is a problem that the stability of ropinirole over time is insufficient.

Method used

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  • Method for producing patch, patch and package
  • Method for producing patch, patch and package
  • Method for producing patch, patch and package

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0154] First, 15.0 parts by mass (13.2 parts by mass in conversion to ropinirole hydrochloride) of ropinirole hydrochloride, 1.6 parts by mass of sodium hydroxide (a desalting agent, 0.8 parts by mass relative to 1 mole of ropinirole hydrochloride) were mixed using a mixer. mol), 11.9 parts by mass of liquid paraffin, toluene (solvent), 11.4 parts by mass of styrene-isoprene-styrene block copolymer (SIS) (SIS5000, produced by JSR), 42.6 parts by mass of alicyclic hydrocarbon resin , 4.5 parts by mass of polyisobutylene, 10.0 parts by mass of isopropyl palmitate, and 3.0 parts by mass of octyldodecanol were mixed to prepare 100 parts by mass (mass of the total amount of the compound excluding the solvent (toluene)) adhesive layer composition. Table 1 shows the composition (excluding toluene) of the aforementioned pressure-sensitive adhesive layer composition. In addition, with regard to the molar ratio of ropinirole hydrochloride and sodium hydroxide, the aforementioned adhesi...

Embodiment 2～12

[0158] Patch preparations were obtained in the same manner as in Example 1, except that the heat treatment conditions were set to the conditions shown in Table 2. As a result of the evaluation of the above-mentioned free body crystals and salt crystals on the patches immediately after manufacture, it was confirmed that the evaluation of free body crystals was A and the evaluation of salt crystals was B in both patches, although ropihydrochloride remained Nile crystals, but ropinirole free form is contained in the adhesive layer in a supersaturated concentration and in dissolved form. A graph showing the results of DSC measurement of the patch obtained in Example 9 immediately after manufacture is at figure 2 shown in .

Embodiment 13

[0160] First, it was obtained in the same manner as in Example 1, except that it had the composition shown in Table 1 and that the amount of sodium hydroxide added was 1.1 moles relative to 1 mole of ropinirole hydrochloride. Adhesive layer composition. In addition, in the above-mentioned molar ratio of ropinirole hydrochloride to sodium hydroxide, the adhesive layer composition does not contain ropinirole hydrochloride but contains 13.2 parts by mass of free ropinirole. In addition, the amount of free ropinirole at this time is an amount having a supersaturated concentration with respect to the aforementioned pressure-sensitive adhesive layer composition (excluding the solvent).

[0161] Then, using the obtained pressure-sensitive adhesive layer composition, except that the heat treatment conditions were the conditions shown in Table 2, it carried out similarly to Example 1, and obtained the patch. As a result of the evaluation of the above-mentioned free body crystals and sal...

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PUM

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Abstract

A method for producing a patch comprising a support layer and an adhesive agent layer arranged on at least one surface of the support layer, the method comprising: step A) obtaining an adhesive agent layer composition comprising free ropinirole in an amount which results in a content of 5 to 13.2% by mass in an obtained adhesive agent layer; step B) heating the adhesive agent layer composition at a temperature in a range from 50 to 76°C for 5 minutes to 24 hours; and step C) cooling the heated adhesive agent layer composition to normal temperature at an average rate of temperature drop of 1 to 20°C / hour, thereby obtaining the adhesive agent layer comprising the free ropinirole at a supersaturated concentration in a dissolved form.

Description

technical field [0001] The present invention relates to a method for producing an adhesive patch, an adhesive patch, and a package, and more specifically, to a method for producing an adhesive patch containing ropinirole as a drug, an adhesive patch obtained by the method, and a package. Background technique [0002] In the past, oral administration methods using tablets, capsules, syrups, etc. have been known as methods for administering drugs. method. The method using an adhesive agent can solve the problems caused by the oral administration method, and has advantages such as a reduction in the number of administrations, an improvement in compliance, and ease of administration and its termination. Therefore, especially when the patient is an elderly person or a child, it is expected as a useful drug administration method. [0003] However, the stratum corneum of normal skin has a barrier function to prevent foreign matter from entering the body. Due to such a barrier fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4045B65D77/00A61P25/16A61P25/14
CPCA61K31/4045A61K9/7053A61P25/14A61P25/16
Inventor 吉崎崇人田中幸司间和之助海宝辉光堤信夫
Owner HISAMITSU PHARM CO INC
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