Fexofenadine hydrochloride dry suspension and preparation method thereof

A technology of fexofenadine hydrochloride and dry suspension, which is applied in the field of fexofenadine hydrochloride dry suspension and its preparation, can solve problems such as excessive flavoring agent content, and achieve good suspending property, Good for storage and good taste

Pending Publication Date: 2022-07-01
SHANGHAI INST OF PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved in the present invention is to provide a kind of fexofenadine hydrochloride dry suspension and preparation method thereof

Method used

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  • Fexofenadine hydrochloride dry suspension and preparation method thereof
  • Fexofenadine hydrochloride dry suspension and preparation method thereof
  • Fexofenadine hydrochloride dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The prescription of fexofenadine hydrochloride dry suspension is as follows in Table 1:

[0043] Table 1 embodiment 1 fexofenadine hydrochloride dry suspension prescription

[0044]

[0045]

[0046] Prepared by the following preparation method:

[0047] (1) Weigh sodium dioctyl sulfosuccinate and ethyl cellulose according to the recipe quantity, and use absolute ethanol to prepare an ethanolic solution containing dioctyl sulfosuccinate sodium and ethyl cellulose, wherein ethyl cellulose The percentage of the total mass of the solution is 10%, and the percentage of the sodium dioctyl sulfosuccinate to the total mass of the solution is 0.68%;

[0048] (2) take by weighing fexofenadine hydrochloride and sucrose according to the recipe quantity, place in a wet granulator, after mixing, add above-mentioned ethyl cellulose / dioctyl sulfosuccinate sodium ethanolic solution for granulation, and make The obtained soft material is sieved and dried, and then sieved to gran...

Embodiment 2

[0051] The prescription of fexofenadine hydrochloride dry suspension is as follows in Table 2:

[0052] Table 2 embodiment 2 fexofenadine hydrochloride dry suspension prescription

[0053] prescription composition % of mass fexofenadine hydrochloride 5.00 sucrose 93.17 Ethyl cellulose 0.50 Dioctyl Sodium Sulfosuccinate 0.04 Xanthan Gum 1.07 Colloidal silica 0.22

[0054] The preparation steps are the same as those in Example 1.

Embodiment 3

[0056] The prescription of fexofenadine hydrochloride dry suspension is as follows in Table 3:

[0057] Table 3 embodiment 2 fexofenadine hydrochloride dry suspension prescription

[0058]

[0059]

[0060] The preparation steps are the same as those in Example 1.

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PUM

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Abstract

The invention discloses a fexofenadine hydrochloride dry suspension and a preparation method thereof. The fexofenadine hydrochloride dry suspension takes fexofenadine hydrochloride as an active pharmaceutical ingredient, and comprises the following components in percentage by mass: 2 to 8 percent of fexofenadine hydrochloride, 89 to 95 percent of filler, 0.5 to 2.0 percent of suspending aid, 0.02 to 0.10 percent of wetting agent and 0.20 to 1.00 percent of flavoring agent. The fexofenadine hydrochloride dry suspension is prepared in a wet granulation mode, the prepared fexofenadine hydrochloride dry suspension is good in taste, good in patient compliance and high in stability, and the drug dissolution rate can be further improved.

Description

technical field [0001] The invention relates to a dry suspension of fexofenadine hydrochloride and a preparation method thereof. Background technique [0002] Fexofenadine is a new type of second-generation antihistamine, and its racemic hydrochloride is used clinically. Fexofenadine is the active metabolite of the antihistamine terfenadine, which removes the potential cardiotoxicity of the parent drug and is mainly used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The advantages of fexofenadine hydrochloride are: 1) clear mechanism of action; 2) long half-life and long duration of action; 3) no liver metabolism, no liver damage, and can be used in children and patients with liver damage; 4) adverse reactions few. [0003] At present, fexofenadine hydrochloride formulations are listed at home and abroad, and the ones listed abroad are mainly tablets, oral suspensions, capsules, and dry syrups. The existing domestic tablets and capsules ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/38A61K47/20A61K31/445A61P37/08A61P11/02A61P17/00
CPCA61K47/26A61K47/38A61K47/20A61K31/445A61P37/08A61P11/02A61P17/00
Inventor 何军章越李莹莹刘洁付庆辉杨凯丽黄俐俐倪美萍褚润璇孙国昊林秀俊芦晓红郭丰年
Owner SHANGHAI INST OF PHARMA IND
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