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Particulate composition and production method therefor

A manufacturing method and composition technology, applied in the field of granular composition and its manufacturing, capable of solving undiscovered problems

Pending Publication Date: 2021-03-26
NIPPON ZOKI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in detail, it has not been found that the production process of the granular composition containing olopatadine or a pharmaceutically acceptable salt thereof in the present invention described later discloses that the generation of fine powder and coarse particles can be suppressed by designing the production process. Method literature

Method used

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  • Particulate composition and production method therefor
  • Particulate composition and production method therefor
  • Particulate composition and production method therefor

Examples

Experimental program
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Effect test

Embodiment 1

[0130] Example 1: Preparation of Granular Compositions and Formulations

[0131] 64.816 parts of white sugar, 0.4 parts of DL-malic acid, 0.4 parts of dibutyl hydroxytoluene, 24 parts of trehalose hydrate, 1 part of olopatadine hydrochloride, 5 parts of acesulfame potassium, 2 parts of dextrin, light 0.25 parts of quality anhydrous silicic acid, 0.44 parts of edetate sodium hydrate, and 1.06 parts of hydroxypropyl cellulose (HPC) were put into the stirring granulator. A granulation solution prepared by separately dissolving 0.44 parts of HPC and 0.004 part of thaumatin in 5 parts of purified water was put thereinto, and granulated. After the granulation, wet mass sizing was carried out with a crushing and sizing machine, and drying was carried out at 45° C. to obtain a granulated dry product 1 . The granulated dry product 1 was charged into a crushing and sizing machine with a mesh of 1000 μm, and the granules were sized to obtain the sized product 1 . The granulated product...

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PUM

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Abstract

The present invention provides: a particulate composition containing olopatadine or a pharmaceutically acceptable salt thereof and having reduced bitterness and therefore is easy to take; a solid medicinal preparation containing the particulate composition; and a method for uniformly and efficiently producing the particulate composition.

Description

technical field [0001] The present invention relates to a granular composition containing olopatadine or a pharmaceutically acceptable salt thereof as an active ingredient, a method for producing the granular composition, a method for producing a preparation using the granular composition, and the like. Background technique [0002] In recent years, for the purpose of improving the convenience of patients, new formulations of various existing drugs have been developed. Providing formulations that meet patients' needs not only helps to improve patient satisfaction with treatment, but also helps reduce the burden on staff who assist patients in taking their medications. [0003] In addition to tablets, solid pharmaceutical preparations also include capsules, granules, powders, dry syrups, etc., and are generally administered orally. Oral administration is the most convenient and versatile method of administration. However, preparations taken with water or lukewarm water tend...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/335A61K9/14A61K9/16A61K47/36A61K47/38A61P11/02A61P17/04A61P37/08
CPCA61K31/335A61K47/36A61K9/14A61K47/38A61P17/04A61K9/16A61P37/08A61P11/02
Inventor 增田清榊原贤司
Owner NIPPON ZOKI PHARM CO LTD
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