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Hydronol preparation

A technology for isosorbide preparations, applied in the field of isosorbide preparations, can solve the problems of large volume, difficult to meet, poor portability, etc.

Inactive Publication Date: 2011-06-22
KOWA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Liquid preparations for oral administration are easier to drink than solid preparations such as granules. On the contrary, since isosorbide has a strong bitter taste unique to it, even if the bitter taste is adjusted by seasoning and odorant, due to individual differences in taste, still can't please everyone
In addition, since the liquid preparation for oral administration contains about 30% water, it is heavy, and it is in the state of a bottle, which is bulky and poor in portability

Method used

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  • Hydronol preparation
  • Hydronol preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The isosorbide is pulverized by a rack type granulator roller granulator (manufactured by Granite-ta-Nippon) to obtain 25% by weight of a part with a particle diameter of less than 355 μm and 1 weight of a part with a particle diameter of 1400 μm or more. % of crystalline isosorbide (moisture content 0.3% by weight). 3960 g of this crystalline isosorbide and 40 g (1.0% by weight of the solid composition) of hydrous silica (Ka-Plex: manufactured by Shionogi Pharmaceutical Co., Ltd.) were charged into a mixer (Bo-recontenamikisa-: manufactured by Kotobuki Giken), According to the rotation speed of 25 rpm, the mixture was mixed for 5 minutes to obtain the pharmaceutical composition. The pharmaceutical composition was fixedly packaged in 7 g each by an aluminum laminate packaging material (powder aluminum packaging film, PET#12 / AC / PE15 / AL9 / PE30: produced by Tamapoli Co., Ltd.) to manufacture isosorbide preparations ( Moisture content 0.3% by weight).

Embodiment 2

[0033] In Example 1, a pharmaceutical composition was obtained by the same method as in Example 1, except that the same amount of light silicic anhydride (Aerosil: produced by Japan Aerosil) was added instead of 40 g of hydrous silica (ka-plex). , the obtained pharmaceutical composition was packaged in the same manner as in Example 1 to manufacture isosorbide preparations (moisture content 0.3% by weight).

Embodiment 3

[0035] 29670 g of crystalline isosorbide (moisture content: 0.1% by weight), 300 g of hydrous silica (ka-plex), 18 g of aspartame (sweetener) and yoghurt were prepared by the same grinding method as in Example 1. 12 g of colloidal particles (ヨ一グルレトミロン) (fragrance) were put into a double-cone mixer (Daburko-Inbrender-: W-100), and mixed at a rotation speed of 25 rpm for 10 minutes to obtain a pharmaceutical composition. This pharmaceutical composition was packaged in the same manner as in Example 1 to produce an isosorbide formulation (dry syrup formulation: moisture content: 0.1% by weight).

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Abstract

An isosorbide preparation of this invention is characterized in that a pharmaceutical composition containing crystalline isosorbide with a water content of 0.5% by weight or less (except for the case where those with a particle size less than 355 mu m are contained in a proportion of 85% by weight or more) and a lubricant is packaged with a water impermeable packaging material containing aluminum. This can stably maintain the pharmaceutical composition containing crystalline isosorbide which is highly hygroscopic and highly caking for a long period of time and the isosorbide preparation excellent also in portability is provided.

Description

technical field [0001] The present invention relates to an isosorbide preparation containing crystalline isosorbide in the fields of pharmaceuticals and quasi-drugs, and more specifically, the present invention relates to a granular or powdered isosorbide preparation that is stable for a long period of time and has excellent portability. Background technique [0002] Isosorbide preparations are widely used as a symptomatic agent for reducing cerebral pressure in brain tumors, reducing cerebral pressure when cerebral pressure increases due to head trauma, diuresis in kidney and ureteral stones, reducing intraocular pressure in glaucoma, and Meniere's disease. . As isosorbide preparations, liquid preparations for internal administration in which multiple doses of the preparations are filled in bottles have been developed and marketed. Liquid preparations for oral administration are easier to drink than solid preparations such as granules. On the contrary, since isosorbide has...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/34A61K9/14A61K47/04
CPCA61K31/34A61K9/145A61K9/14A61K9/16
Inventor 前原孝典饭野真由美原猛哲须藤俊宏
Owner KOWA CO LTD
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