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Process for preparation of anti-tubercular combination and pharmaceutical composition prepared therefrom

A pharmaceutical composition, tuberculosis technology, applied in the direction of antibacterial drugs, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of long disintegration time of tablets

Active Publication Date: 2012-02-08
TAIWAN BIOTECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This may be due to the longer disintegration time of the tablet granulated by the 2-step granulation method

Method used

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  • Process for preparation of anti-tubercular combination and pharmaceutical composition prepared therefrom
  • Process for preparation of anti-tubercular combination and pharmaceutical composition prepared therefrom
  • Process for preparation of anti-tubercular combination and pharmaceutical composition prepared therefrom

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0102] Example 1: The preparation method of the FDC composition of two layers of four kinds of drugs

[0103] These drugs: rifampicin, isoniazid, pyrazinamide, and ethambutol are available to those skilled in the art. For example, rifampicin, isoniazid, pyrazinamide, and ethambutol hydrochloride are available from BTX Global Pharmaceuticals, Inc. (New Jersey, US), F. Hoffmann-La Roche Ltd (New Jersey, US), respectively. ); Pharmchem Co. (New Delhi, India) and CBC (America) Corp (New York, US). The ingredients and their specific levels are listed in the table below.

[0104] Table 1: Formulations of RIP081231T

[0105] project

Element

% weight / weight

Tier I

1

rifampicin

14.02％

2

magnesium hydroxide

0.93％

3

Magnesium stearate

0.93％

4

Granules - placebo

7.95％

Subtotal

23.83％

Tier II

5

polyethylene glycol

0.94％

6

Particl...

example 2

[0129] Example 2: Stability test of compositions of the present invention

[0130] Stability testing was performed by using the RIP080813T lozenge prepared in Example 1 under the conditions described in the guidelines of the International Conference on Harmonization. The conditions for the long-term test are 25°C and 60%RH. The conditions of the accelerated test are 40° C. and 75% RH. The results are shown in Table 1 below.

[0131] Table 1: Conditions for accelerated testing

[0132]

[0133]

[0134] As shown in the table, the FDC compositions of the present invention exhibit excellent stability.

example 3

[0135] Example 3: Pharmacokinetic studies in humans in vivo

[0136] Conduct clinical trials. The individual is divided into three groups and tested respectively RIP080813T, RIP081231T (composition of the present invention among the example 1) and

[0137] Before administration, 10 ml of blood was collected from each individual as a blank control. In the trial, individuals were given two RIP080813T lozenges, one RIP081231T lozenge, and one RIP081231T lozenge at different times Lozenges and 10 ml of blood were collected from each subject. Rifampicin, isotropic acid and isotropic acid were calculated from blood concentrations obtained at time intervals after administration (i.e., at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 36 hours). Pharmacokinetic parameters (Cmax and AUC) of nicotinic acid hydrazine, pyrazinamide and ethambutol hydrochloride.

[0138] The results shown in Table 3 below demonstrate that compared to RIP080813T and RIP081231T of the present invention ...

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Abstract

This invention relates to a process for preparing a pharmaceutical composition comprising four antitubercular drugs: rifampin or a pharmaceutically acceptable salt thereof, isoniazid or a pharmaceutically acceptable salt thereof, pyrazinamide or a pharmaceutically acceptable salt thereof and ethambutol or a pharmaceutically acceptable salt thereof, wherein rifampin and isoniazid are in separate layers. The invention also provides a pharmaceutical composition prepared therefrom having advantageous stability and bioavailability.

Description

[0001] 【Technical field to which the invention belongs】 [0002] The present invention relates to a method for preparing a pharmaceutical composition comprising the following four anti-tuberculosis drugs: rifampicin, isoniazid, pyrazinamide and ethambutol, wherein rifampicin and isoniazid are located at in separate layers. The present invention also provides a pharmaceutical composition prepared by the method, which has excellent stability and bioavailability. 【Background technique】 [0003] Tuberculosis (TB) is one of the most common infectious diseases known to mankind. Although effective treatment is available with four drugs: rifampincin, isoniazid, ethambutol, and pyrazinamide, the high doses and long duration required for treatment contribute to adverse outcomes in TB patients. Medication adherence. The failures of these anti-tuberculosis treatments are basically due to partial or non-adherence to the recommended regimens. In addition, resistance to partial medicatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K31/4965A61K31/133A61K31/4409A61P31/06
CPCA61K31/497A61K9/209A61K9/2095A61K9/2077A61K31/166A61K9/2866A61P31/06A61K2300/00
Inventor 鲍力恒萧年亨杨国华周瑞铭
Owner TAIWAN BIOTECH
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