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Soft capsule preparation

A technology of soft capsules and capsules, which is applied in the direction of capsule delivery, medical preparations of non-active ingredients, organic active ingredients, etc., which can solve the problems of reduced content stability, complicated drying process, and soft capsule adhesion depressions, etc., to achieve simplification Excellent drying process and content stability

Inactive Publication Date: 2018-01-19
TOKAI CAPSULE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, if hydrophilic polyethylene glycol is used as a base, it is easy to cause adhesion and depression of soft capsules due to moisture.
Therefore, strict water management is required for soft capsules, and the drying process tends to become complicated
In addition, it is considered that since hydrophilic polyethylene glycol is used as a base, the content stability of nafuraphine decreases and decomposition products are generated due to water contained in polyethylene glycol.

Method used

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  • Soft capsule preparation
  • Soft capsule preparation
  • Soft capsule preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The preparation of embodiment 1 soft capsule

[0045] Dissolve the prescribed amount of nafuraphine hydrochloride and propyl gallate shown in the following table 1 in the prescribed amount of ethanol, and mix it with the prescribed amount of medium-chain fatty acid triglyceride [tri(caprylic acid / capric acid] Acid) glyceride (manufactured by BASF)] and stirred to prepare a capsule filling composition. Stir to disperse the specified amount of gelatin, succinylated gelatin, concentrated glycerin, D-sorbitol solution, sodium thiosulfate and titanium oxide shown in the following Table 1 in an appropriate amount of purified water, and stir at 60°C to dissolve Then, vacuum defoaming was performed to prepare a gelatin film. Soft capsules were prepared using the above-mentioned capsule filling composition and gelatin film by punching using a rotary automatic soft capsule molding machine.

[0046] In addition, 2.5 μg of REMITCH capsules [2.5 μg of nalfurine hydrochloride (manu...

Embodiment 2

[0053] Embodiment 2 stability test

[0054] The soft capsule prepared in Example 1 was put into a glass bottle, and stored at 80° C. for 1 week in a fastened state. Utilize HPLC (high performance liquid chromatography, high-performance liquid chromatography) method to measure the content and decomposition product of nafuraphine hydrochloride in each soft capsule after storage time ends. The measurement results are shown in Tables 3 and 4.

[0055] [table 3]

[0056] Residual rate of nafurphine hydrochloride in soft capsules

[0057]

[0058] [Table 4]

[0059] Amount of decomposed substances in soft capsules

[0060]

[0061] According to Table 3, it can be clearly seen that the product of the present invention has a higher residual rate of nafuraphine hydrochloride than the comparative product, showing remarkable content stability. Also, as is clear from Table 4, the product of the present invention did not increase the 10α-OH form seen in the comparative product, ...

Embodiment 3

[0062] The preparation of embodiment 3 soft capsules

[0063] Soft capsules were prepared in the same manner as in Example 1 in the prescribed amounts shown in Table 5 below.

[0064] In addition, 2.5 μg of REMITCH capsules [2.5 μg of nalfuraphine hydrochloride (manufactured by Toray Co., Ltd.) prepared in one capsule) was used as a comparative product in the same manner as in Example 1.

[0065] [table 5]

[0066] Composition of the invention

[0067]

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PUM

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Abstract

Provided is a soft capsule preparation that shows an excellent content stability of Nalfurafine or an acid addition salt thereof. The soft capsule preparation consists of a capsule core comprising Nalfurafine or an acid addition salt thereof, a hydrophobic oily base and propyl gallate, and a capsule coating comprising sodium thiosulfate.

Description

technical field [0001] The invention relates to a soft capsule containing nafuraphine or an acid addition salt thereof. Background technique [0002] Nalfurafine, as a selective opioid κ receptor agonist, exhibits a strong antipruritic effect on central itching interfered with by the opioid system (Patent Document 1). Furthermore, soft capsules containing nalfuraphine hydrochloride are marketed as oral pruritus improving agents. [0003] However, Nafuraphine is chemically unstable to heat, light, oxygen, and moisture, so methods such as low-temperature storage, shading, and inert gas replacement must be adopted during storage. [0004] Therefore, the stability of capsules containing nafuraphine or its acid addition salt is ensured by mixing sodium thiosulfate as a water-soluble antioxidant with water and polyethylene glycol (Patent Document 2). [0005] However, when hydrophilic polyethylene glycol is used as a base, adhesion and depression of soft capsules due to moisture...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K9/48A61K47/02A61K47/10A61P17/04A61P43/00
CPCA61K9/48A61K31/485A61K47/02A61K47/10A61K9/4816A61K9/4858A61K47/14
Inventor 佐野保彦后藤浩士中岛祥充西田圭
Owner TOKAI CAPSULE
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