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Pharmaceutical composition containing micronized fexofenadine hydrochloride

A technology of fexofenadine hydrochloride and its composition, which is applied in the field of micronized fexofenadine hydrochloride pharmaceutical composition and its pharmaceutical preparations, can solve the problems of satisfactory bioavailability and discomfort for clinical use, and achieve the purpose of alleviating itching The effect of the number of wheals

Active Publication Date: 2015-06-17
KUSN ROTAM REDDY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the prior art teaches the existence of micronization technology of fexofenadine hydrochloride, however, its bioavailability is not satisfactory to patients and is not suitable for clinical use

Method used

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  • Pharmaceutical composition containing micronized fexofenadine hydrochloride
  • Pharmaceutical composition containing micronized fexofenadine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0043] Fexofenadine hydrochloride raw material is ultrafinely pulverized using a mechanical pulverizer, the pulverized raw material particles are collected, and the particle size of the micropowder is measured using a Malvern laser particle size analyzer, and the particle size at 95% of the cumulative volume is below 30 μm, namely, Micronized fexofenadine hydrochloride.

preparation example 2

[0045] Fexofenadine hydrochloride raw material is ultrafinely pulverized by jet mill, the raw material particles after pulverization are collected, and the particle size of the fine powder is measured by Malvern laser particle size analyzer. The particle size at 95% cumulative volume is below 20 μm, namely, Micronized fexofenadine hydrochloride.

preparation example 3

[0047] (1) Fexofenadine hydrochloride is pre-crushed by a fluid energy mill using collision technology to make particles with a particle size of 80 μm,

[0048] (2) Adopt CWJ-30 type superfine pulverizer to carry out superfine pulverization to the above-mentioned coarse particles, pulverize into 5-10 μ m fine powder,

[0049] Grinding conditions: the air temperature after freeze-drying is 6°C, the water content is 0.5%, the pressure when injected into the ultrafine pulverizer is 0.8MPa, the working pressure of the ultrafine pulverizer is 0.8MPa, the internal working temperature is 6°C, and the pulverization time is 50min.

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Abstract

The invention provides micronized fexofenadine hydrochloride. The particle size of fexofenadine hydrochloride at 95% cumulative volume is 60mu m or below. The invention also provides a method for preparing the micronized fexofenadine hydrochloride, a pharmaceutical composition containing the micronized fexofenadine hydrochloride, as well as a preparation method of the pharmaceutical composition. According to the invention, a solid preparation by taking the micronized fexofenadine hydrochloride as the active ingredient has excellent dissolution rate in vitro and has high dissolution characteristics under various pH conditions, the corresponding effects of the medicine in vivo in different crowds can be effectively guaranteed, and the problem that the bioavailability of the medicine in vivo is reduced so as to influence the curative effect because the conventional fexofenadine hydrochloride medicine is difficult to dissolve in an in-vivo gastrointestinal environment is solved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a pharmaceutical composition containing micronized fexofenadine hydrochloride and pharmaceutical preparations thereof. Background technique [0002] Fexofenadine hydrochloride is a second-generation H1 receptor antagonist, which is a carboxylated metabolite of terfenadine, which selectively blocks H1 receptors and has good antihistamine effects, but No anti-serotonin, anticholinergic and antiadrenergic effects. [0003] Animal studies have shown that fexofenadine hydrochloride tablets can selectively inhibit antigen-induced bronchospasm in sensitized guinea pigs; it can inhibit the release of histamine from peritoneal mast cells in rats; it has no anti-parasympathetic neurophysiological effects or α * adrenaline Receptor blocking effect; and fexofenadine hydrochloride has no sedative effect and other central nervous system effects. Therefore, it cannot pass through the blood-brain barri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/20A61K31/445A61P11/02A61P37/08A61P17/00
Inventor 刘火李吉荣刘细女
Owner KUSN ROTAM REDDY PHARMA
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