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Pharmaceutical composition comprising fexofenadine

A technology of fexofenadine hydrochloride and its composition, which is applied in the field of stable pharmaceutical compositions of fexofenadine hydrochloride, can solve the problems of improving the storage stability and shelf life of pharmaceutical compositions without record

Inactive Publication Date: 2014-03-26
AVENTIS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, this document does not describe the technical problem of improving storage stability and shelf life of pharmaceutical compositions comprising piperidinoalkanol compounds

Method used

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  • Pharmaceutical composition comprising fexofenadine
  • Pharmaceutical composition comprising fexofenadine
  • Pharmaceutical composition comprising fexofenadine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1: Compositions of the invention

[0073]

[0074] *The specific surface area is 3.2m 2 / g

[0075] Disperse all excipients. Fexofenadine hydrochloride was dispersed with polysorbate 80 in propylene glycol monolaurate (glyceryl laurate) (under continuous stirring). The mixture was stirred for 45 minutes. The pH of the resulting mixture was adjusted to pH 5-6 with triethanolamine if necessary. The formulation is encapsulated in soft gelatin capsules with a fill weight of 900 mg (for 180 mg strength) according to one of the methods known to those skilled in the art.

Embodiment 2

[0076] Example 2: Compositions of the invention

[0077]

[0078]

[0079] *The specific surface area is 3.2m 2 / g

[0080] Disperse all excipients. Fexofenadine hydrochloride was dispersed together with propylene glycol monocaprylate (propylene glycol caprylate-90) by heating to 125°C-165°C under continuous stirring until a clear solution formed. The resulting mixture was cooled to room temperature. The formulation is encapsulated in soft gelatin capsules according to one of the methods known to those skilled in the art.

Embodiment 3

[0081] Embodiment 3: Stability study of the composition of the present invention

[0082] The tested pharmaceutical composition for oral administration is based on the following formula (Fill Composition A):

[0083] Element

Features

Mg / capsule

%w / w

Fexofenadine HCL*

Active ingredients

180.00

30.0

Glyceryl Laurate-90

lipophilic surfactant

384.00

64.0

Tween 80

Hydrophilic Surfactant

36.00

6.0

Triethanolamine

pH regulator

Appropriate to pH5-6

total weight

600mg

[0084] *The specific surface area is 3.2m 2 / g

[0085] production method:

[0086] 1. Mix fexofenadine, glyceryl laurate 90, and Tween 80 in a stainless steel container for 15 minutes;

[0087] 2. Use a sufficient amount of triethanolamine to adjust the pH to 5-6;

[0088] 3. using one of the methods known to those skilled in the art to fill soft gel capsules with the mixture obtai...

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Abstract

The present invention relates to a pharmaceutical formulation of fexofenadine hydrochloride in a solvent system suitable as a liquid fill composition. In another aspect, the invention also relates to a process for the preparation of the said pharmaceutical formulation and the use of said composition for the preparation of a drug for the treatment of allergic reactions in a patient.

Description

technical field [0001] The present invention relates to stable pharmaceutical compositions of fexofenadine hydrochloride (HCl) for oral administration. [0002] In particular, the present invention relates to improved formulations comprising fexofenadine hydrochloride and pharmaceutically acceptable excipients, optionally encapsulated in soft gelatin capsules. [0003] The invention furthermore relates to a process for the preparation of said pharmaceutical composition and the use of said pharmaceutical composition for the preparation of a medicament for the treatment of allergic reactions. Background technique [0004] Fexofenadine has poor solubility in aqueous solutions, presenting intractable problems in formulating said compound for effective administration to patients. A well-designed formulation should at least be able to deliver a therapeutically effective amount of the hydrophobic compound in an absorbable form to the desired site of absorption. Even the above min...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/10A61K31/4545
CPCA61K31/445A61K9/48A61K47/10A61K31/4545A61K9/4816A61K9/4866A61P37/00A61P37/08
Inventor S.R.巴达巴格尼N.杰斯瓦尔P.库拉K.普拉萨德
Owner AVENTIS PHARMA INC
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