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A solid pharmaceutical formulation

一种配制剂、药物的技术，应用在持续释放的固体药物配制剂领域，能够解决药物释放性能不是那么好、降低固体配制剂坚固性等问题

Inactive Publication Date: 2015-10-14
OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has the disadvantage of reducing solid formulation firmness and the drug release properties of administered starch-containing formulations are not so good

Method used

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  • A solid pharmaceutical formulation
  • A solid pharmaceutical formulation
  • A solid pharmaceutical formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Corn starch (trade name: "Nisshoku Corn Starch", manufactured by Nippon Shokuhin Kako K.K.) (90 g), crystalline cellulose (trade name: "CEOLUS PH301", manufactured by Asahi Kasei Corporation) (30 g), hydroxypropyl acetate Athylmethylcellulose succinate (trade name: "AS-HF", manufactured by Shin-Etsu Chemical Co., Ltd.) (30 g) and cilostazol (manufactured by Otsuka Pharmaceutical Co., Ltd.) (150 g ) was mixed, the mixture was put into an accelerated kneader (model: NSK-150, manufactured by Okada Seiko K.K.), and then 37.5 mL of 4% polysorbate 80 aqueous solution (containing 1.5 g Polysorbate 80) and purified water (92.5 g) to obtain a starting composition (starting composition example 1).

[0071] The starting composition was subjected to extrusion granulation with an extrusion granulator equipped with a dome die (hole diameter: 0.6 mm, DomeGran DG-L1, manufactured by DALTON Co. LTD.) to obtain wet granules. The wet granules were treated with a spheroidizer (Murmerizer ...

Embodiment 2

[0074] Corn starch (trade name: "Nisshoku Corn Starch", manufactured by Nippon Shokuhin Kako K.K.) (90 g), crystalline cellulose (trade name: "CEOLUS PH301", manufactured by Asahi Kasei Corporation) (30 g), hydroxypropyl acetate Athylmethylcellulose succinate (trade name: "AS-HF", manufactured by Shin-Etsu Chemical Co., Ltd.) (30 g) and cilostazol (manufactured by Otsuka Pharmaceutical Co., Ltd.) (150 g ) was mixed, the mixture was put into an accelerated kneader (model: NSK-150, manufactured by Okada Seiko K.K.), and then 37.5 mL of 4% polysorbate 80 aqueous solution (containing 1.5 g Polysorbate 80) and purified water (67.5 g) to obtain a starting composition (starting composition example 2).

[0075] The starting composition was subjected to extrusion granulation with an extrusion granulator equipped with a dome die (hole diameter: 0.6 mm, DomeGran DG-L1, manufactured by DALTON Co. LTD.) to obtain wet granules. The wet granules were treated with a spheroidizer (Murmerizer ...

Embodiment 3

[0078]Corn starch (trade name: "Nisshoku Corn Starch", manufactured by Nippon Shokuhin Kako K.K.) (69 g), crystalline cellulose (trade name: "CEOLUS PH301", manufactured by Asahi Kasei Corporation) (51 g), methacrylic acid Copolymer L (trade name: "Eudragit L100", manufactured by EVONIK) (30 g) and cilostazol (manufactured by Otsuka Pharmaceutical Co., Ltd.) (150 g) were mixed, and the mixture was put into an accelerating kneader (model: NSK-150, manufactured by Okada Seiko K.K.), and purified water (130 g) was added thereto with stirring to obtain a starting composition (starting composition example 3).

[0079] The starting composition was subjected to extrusion granulation with an extrusion granulator equipped with a dome die (hole diameter: 0.6 mm, DomeGran DG-L1, manufactured by DALTON Co. LTD.) to obtain wet granules. The wet granules were treated with a spheroidizer (Murmerizer QJ-400, manufactured by DALTON Co. LTD.) to adjust the shape and size of the granules, thereb...

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Abstract

The present invention relates to a sustained-release solid pharmaceutical formulation comprising (a) an active medical ingredient, (b) a pre-gelatinized starch in an amount of 10 to 90% by weight based on the whole weight of the formulation and (c) one or more kinds of enteric ingredients.

Description

[0001] This application is a divisional application of an invention patent application with an application date of May 14, 2009, an invention title of "solid pharmaceutical preparation", and an application number of 200980117393.1. technical field [0002] The present invention relates to a solid pharmaceutical formulation. More specifically, it relates to a sustained release solid pharmaceutical formulation comprising (a) an active pharmaceutical ingredient, in particular cilostazol, (b) a pregelatinized starch in an amount of 10-90% by weight, based on The total weight of the formulation, and (c) one or more enteric ingredients. Background technique [0003] Sustained-release solid pharmaceutical formulations are useful formulations because it is possible to control the blood concentration of the active ingredient, to modify the dosing conditions (e.g. reduce the frequency of dosing), to increase the active ingredient (which has a short duration in living organisms). half...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/22A61K9/52A61K31/4709A61K47/36A61K47/38A61K47/32A61P7/02A61P9/00A61P29/00A61P9/14A61P11/06A61P9/12A61P9/10
CPCA61K31/4709A61K9/1635A61K9/1652A61K9/1694A61P11/06A61P29/00A61P7/02A61P9/00A61P9/10A61P9/12A61P9/14
Inventor 向井正志
Owner OTSUKA PHARM CO LTD
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