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Fine granules having improved suspension performance in water

A fine-grained, hydrophilic technology, applied in the direction of organic active ingredients, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of not being able to suppress bitterness, and achieve excellent fine-grained, inhibiting The production of similar substances and the effect of improving suspension

Active Publication Date: 2011-05-11
SHIONOGI & CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But there is a problem that when it is taken as fine granules, the fine granules cannot suppress the bitter taste

Method used

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  • Fine granules having improved suspension performance in water
  • Fine granules having improved suspension performance in water
  • Fine granules having improved suspension performance in water

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0074] (1) Preparation of fine particles containing main active ingredients

[0075] First, about 40% by weight or less of a pharmaceutical compound, especially a pharmaceutical compound with an unpleasant taste; about 5 to about 25% by weight of a waxy substance; about 5 to about 35% by weight of a water-swellable substance; and Other additives such as binders, lubricants, sweeteners and coloring agents are required for mixing. The mixed powder is compressed to form flakes, and then the flakes are crushed. Next, the obtained particles are classified by a sieve, and the primary particles are obtained by adjusting the particle size to an optional particle size [granulation process].

[0076] All the materials used herein and the below-mentioned additives were subjected to the following treatments listed in Table 1 according to their properties in order to efficiently perform the mixing process.

[0077] [Table 1]

[0078]

[0079] Next, the primary particles are heated to...

Embodiment 1

[0091] (1) Preparation of fine granules containing main active ingredients and sweet fine granules

[0092] By the components listed in Table 2, according to the method recorded in the patent document (W02005 / 039538), that is, figure 1 with 2 process to prepare fine particles containing the main active ingredient. Sweet fine granules are also prepared according to the methods described in the above-mentioned patent documents.

[0093] Table 2

[0094]

[0095] (2) Preparation of fine granules containing hydrous silicon dioxide or sodium lauryl sulfate

[0096] Powdered sodium lauryl sulfate was processed according to Table 1 above. Specifically, to obtain fine particles for blending, sodium lauryl sulfate was ground with an ultracentrifugal mill ZM200 (filter: 1 mm; rotation speed: low) so that the 50% average particle diameter was 50 μm or less. Next, as shown in Table 3 below, suspension Liyu powder was prepared by blending fine particles of sodium lauryl sulfate and...

Embodiment 4-6 and comparative Embodiment 2-3

[0101] Liquid or waxy surfactants are treated according to Table 1 above to obtain fine particles for blending. Next, according to Table 4 below, a predetermined amount of fine granules for blending was weighed and mixed in a bag with the fine granules containing the main active ingredient. Next, desired fine granules are produced by mixing the above-obtained granules with sweet fine granules, ferric oxide quintuplet and other additives in a bag.

[0102] [Table 4]

[0103]

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Abstract

The object aims to improve the suspension performance of fine granules in water. The water-wettability and the suspension performance in water of fine granules can be improved by adding an additive such as polyoxyethylene(160) polyoxypropylene(30) glycol to the fine granules.

Description

technical field [0001] The invention relates to a method for improving the suspension of pharmaceutical fine granules in water and novel fine granules prepared by the method. Specifically, the present invention relates to a method for improving the suspension in water of a fine granule containing cefcapene pivoxil hydrochloride as an active ingredient and a novel fine granule prepared by the method. Background technique [0002] When drugs are administered orally, powders are useful dosage forms that can be expected to be absorbed more quickly than tablets or capsules. In particular, fine granules are widely used because they are easier to take than powders. However, fine granules are often difficult to administer if the drug has an unpleasant taste such as bitterness. Therefore, a technique of coating the surface of fine granules has been developed for ingestion without unpleasant taste (for example, see Patent Document 1 below). [0003] Cefcapene pivoxil hydrochloride ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/10A61K9/14A61K9/50A61K47/04A61K47/34A61P31/04
CPCA61K9/1605A61K31/546A61P31/04
Inventor 吉冈一显野网诚友重龙治
Owner SHIONOGI & CO LTD
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