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Asenapine-containing adhesive patch

A technology of patch and base, applied in the field of patches containing asenapine, can solve the problem of no sales, and achieve the effects of excellent adhesion, inhibition of cold flow, excellent storage stability and operability

Pending Publication Date: 2021-08-06
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, no dosage forms other than sublingual tablets are marketed

Method used

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  • Asenapine-containing adhesive patch
  • Asenapine-containing adhesive patch
  • Asenapine-containing adhesive patch

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0076] Example 1: Preparation of Patch (High Viscosity + Medium Viscosity)

[0077] Patches 1 to 7 were prepared according to the ingredients shown in Table 1. And, the quality of the adhesive is 100g / m 2 (setting value).

[0078] Table 1

[0079]

[0080] PSA-4202: BI0-PSA (registered trademark) 7-4202 Silicone adhesive (manufactured by Dow Corning Corporation)

[0081] PSA-4302: BI0-PSA (registered trademark) 7-4302 Silicone adhesive (manufactured by Dow Corning Corporation)

example 2

[0082] Example 2: Dynamic viscoelasticity test

[0083] Using patches 1, 3 to 7 as samples, the loss elastic modulus and storage elastic modulus were measured under the following conditions, and the loss tangent (tan δ value) was calculated (N=1 or 2).

[0084] Measurement conditions

[0085] Equipment: HAAKE MARS III (manufactured by Thermo Fisher Scientific Co., Ltd.)

[0086] Sample part: parallel flat plate with a diameter of 8mm

[0087] Gap spacing: 1mm

[0088] Sample size: 130mg±10mg

[0089] Temperature: 32°C

[0090] Frequency: 1Hz

[0091] Tilt: 1%

[0092] Table 2 shows the results of the loss tangent (tan δ value) calculated from the values ​​of the storage elastic modulus and loss elastic modulus obtained by the dynamic viscoelasticity test.

[0093] Table 2

[0094]

example 3

[0095] Example 3: Viscosity measurement

[0096] The viscosities (N=2) of patches 1, 3 to 7 at 90° C. were measured by the following measurement conditions and using a flow tester (manufactured by SHIMADZU Corporation, product name “FLOWTESTER CFT-500”). The results are shown in Table 3.

[0097] Measurement conditions

[0098] Heating temperature: 5.0°C / min

[0099] Die hole diameter: 0.5mm

[0100] Die length: 1.0mm

[0101] Test weight: 50.0kg

[0102] table 3

[0103]

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Abstract

The present invention addresses the issue of providing an asenapine-containing adhesive patch having excellent adhesive and handling properties, which uses a silicone adhesive base, increasing skin-permeation properties, inhibits cold flow during storage or during adhesion, and maintains the appropriate dosage form over a long period of time and keeps the drugs in the adhesive patch stable during storage, thus continually enabling a sufficient drug efficacy. The present invention relates to an adhesive patch comprising a support and an adhesive layer, the adhesive layer comprising an adhesive base that comprises asenapine and silicone, the loss tangent (tan[delta]) of the adhesive layer being 0.75-1.5 at 1.0Hz.

Description

technical field [0001] The present invention relates to a patch containing asenapine in an adhesive layer and a manufacturing method thereof. Background technique [0002] Sublingual tablets (Sycrest (registered trademark) sublingual tablet and Saphris (registered trademark) sublingual tablet) are already on the market as a drug for treating central nervous system diseases such as schizophrenia and asenapine. Currently, no dosage forms other than sublingual tablets are marketed. [0003] Patch preparations containing asenapine have been described in, for example, Patent Documents 1 to 5, and research has focused on patch preparations using a rubber-based adhesive base or an acrylic adhesive base. [0004] An asenapine-containing patch comprising a combination of a silicone adhesive and a polyacrylate adhesive is described, for example, in Patent Document 6, especially Example 14. [0005] prior art literature [0006] patent documents [0007] Patent Document 1: Internat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/407A61K9/70A61K47/10A61K47/12A61K47/18A61K47/22A61K47/34A61P25/18
CPCA61K47/10A61K47/12A61K31/407A61P25/18A61K47/20A61K47/183A61K9/7069A61K47/22
Inventor 行弘政树高木祐香天野智史
Owner HISAMITSU PHARM CO INC
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