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Fexofenadine hydrochloride dry suspension, and preparation method thereof

A technology of fexofenadine hydrochloride and dry suspension, which is applied in the field of pharmaceutical preparations and can solve problems such as poor solubility, slow dissolution, and poor uniformity of preparations

Inactive Publication Date: 2018-01-05
ZHEJIANG POLY PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage forms of fexofenadine hydrochloride approved for marketing in China include tablets and capsules, and there is no new oral preparation suitable for special populations such as children, elderly patients, and patients with swallowing disorders
And, the dosage of fexofenadine hydrochloride preparation is very little, and the uniformity of preparation is poor, and the dissolubility of this product is poor simultaneously, and dissolution is slow

Method used

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  • Fexofenadine hydrochloride dry suspension, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prepare fexofenadine hydrochloride dry suspension, adopt the following prescription: (unit: g)

[0021]

[0022] And adopt following preparation method to prepare:

[0023] 1. Weigh fexofenadine hydrochloride, polysorbate 80 and polyvinylpyrrolidone K30 according to the prescription amount, add 95% ethanol in the prescription amount, stir and dissolve to obtain a drug-containing solution for later use;

[0024] 2. Weigh mannitol, sucrose, microcrystalline cellulose and sodium carboxymethyl cellulose according to the prescription amount, place them in the top spray device of the multi-functional granulator coating machine, turn on the equipment, add the drug-containing solution obtained in step 1 to carry out Top-spray granulation, the obtained granules are passed through a 24-mesh sieve for granulation, and then mixed evenly with the added xanthan gum, aspartame, essence and silicon dioxide, and then packaged separately.

[0025] 2. Weigh mannitol, sucrose, microcry...

Embodiment 2

[0028] Prepare fexofenadine hydrochloride dry suspension, adopt following prescription:

[0029] Material name

[0030] The preparation method is the same as in Example 1.

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Abstract

The invention relates to a fexofenadine hydrochloride dry suspension, and a preparation method thereof. The fexofenadine hydrochloride dry suspension is prepared from, by weight, 1 to 3% of medicine active component e fexofenadine hydrochloride, 20 to 70% of a filling agent, 20 to 70% of a flavouring agent, 0.1 to 0.5% of a flow aid, 0.3 to 0.8% of a suspending aid, 3 to 9% of an adhesive, and 0.5to 2% of a cosolvent. The fexofenadine hydrochloride dry suspension is capable of solving a patient compliance problem, and in the prior art, is suitable for elders, children, and patients with dysphagia; in preparation, a solid dispersion solution is adopted for pelleting, so that problems such as nonuniform content caused by low content, and slow dissolving caused by poor dissolvability are solved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an antihistamine, in particular to a fexofenadine hydrochloride dry suspension and a preparation method thereof. Background technique [0002] Fexofenadine hydrochloride is a second-generation H1 receptor antagonist, mainly used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. At present, about 40% of people in the world suffer from allergic diseases, among which children have the largest number. Fexofenadine hydrochloride is a new drug for the treatment of allergic rhinitis and chronic idiopathic urticaria. It is the active metabolite of the antihistamine drug terfenadine, which removes the cardiotoxicity of the parent fenadine, cannot pass through the blood-brain barrier, absorbs quickly in the body, reaches the peak concentration in 1-1.5 hours after oral administration, and has a half-life of 11- 14 hours. In addition to the advan...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K31/445A61P37/08A61P11/02A61P17/00
Inventor 范敏华
Owner ZHEJIANG POLY PHARMA
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