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Fexofenadine hydrochloride oral disintegrating drug composition

A fexofenadine, orally disintegrating technology, applied in the field of fexofenadine hydrochloride orally disintegrating pharmaceutical composition and its preparation, can solve the problem of moisture sensitivity and easy oxidation of fexofenadine hydrochloride , low hardness, low strength, high brittleness and other problems, to achieve the effect of reducing market risk, simple method and high bioavailability

Inactive Publication Date: 2012-06-27
JIANGSU GAOSHIDA ELECTRIC TOOL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018]The product made by freeze-drying technology has high brittleness, low hardness and low strength, and high production cost; the product made by wet pellet molding technology is brittle Medium brittleness, average hardness and strength, medium production cost; products made with blank high-performance auxiliary materials have high brittleness and low hardness; products made by conventional tableting technology have low production cost, but high brittleness , low hardness, the above products are not conducive to transportation and storage
[0019] Fexofenadine hydrochloride has moisture sensitivity, easy oxidation, metastableness, thereby has considerable atmospheric instability, so adopt the above-mentioned preparation method, The quality of the produced products cannot be guaranteed

Method used

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  • Fexofenadine hydrochloride oral disintegrating drug composition
  • Fexofenadine hydrochloride oral disintegrating drug composition
  • Fexofenadine hydrochloride oral disintegrating drug composition

Examples

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Embodiment 1

[0087] The orally disintegrating pharmaceutical composition of fexofenadine hydrochloride described in every 1000, its formula consists of:

[0088] Fexofenadine hydrochloride as fexofenadine 300g

[0089] Povidone 60g

[0090] Purified water 600g

[0091] Spray Dried Mannitol Spherical Granules 1500g

[0092] Talc powder 80g

[0093] Hypromellose E5LV 300g

[0094] Purified water 2000g

[0095] Croscarmellose Sodium 300g

[0096] Aspartame 50g

[0097] Silica 10g

[0098] Fexofenadine hydrochloride orally disintegrating pharmaceutical composition of the present invention is prepared by the following method:

[0099] 1) Fexofenadine hydrochloride coating preparation:

[0100] Fexofenadine hydrochloride as fexofenadine 300g

[0101] Povidone 60g

[0102] Purified water 600g

[0103]2) Preparation of Fexofenadine Hydrochloride Granules: Put 1.5kg of spray-dried mannitol spherical particles with an average particle size of 100um into a fluidized bed coating agent, and...

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Abstract

The present invention provides a fexofenadine hydrochloride oral disintegrating drug composition. The fexofenadine hydrochloride oral disintegrating drug composition has characteristics of good stability, high bioavailability, and cost reducing. With the fexofenadine hydrochloride oral disintegrating drug composition of the present invention, the industrialization is achieved, the good clinical application is provided, and the obvious advantage is provided.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a fexofenadine hydrochloride orally disintegrating pharmaceutical composition and a preparation method thereof. Background technique [0002] Sanofi-Aventis announced that its anti-allergic drug Allegra (fexofenadine) has been approved by the FDA as an OTC product, applicable to adults and children over 2 years old. In March 2011, Allegra preparations can be officially sold in the United States as OTC products. Allegra formulations include Allegra, Allegra-D (12 hours) and Allegra-D (24 hours). In my country, the main drugs in the anti-allergy drug market are loratadine, cetirizine, desloratadine, levocetirizine, mizolastine, ebastine, epinastine, fexofena Certainly. According to the data of Minet-Clinical Drug Competition, Loratadine has the largest market share, close to 30%. In my country's over-the-counter drug list (OTC), only two of the above-mentioned main antialler...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/445A61K47/38A61P11/02A61P37/08A61P17/00
Inventor 张昊
Owner JIANGSU GAOSHIDA ELECTRIC TOOL CO LTD
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