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Sublingual pharmaceutical composition containing ibutilide and preparation method thereof

A composition and drug technology, applied in the field of medicine, can solve the problems of uneven drug distribution, inaccurate quantification, incomplete absorption, etc., and achieve the effect of guaranteed therapeutic effect, stable process and fast onset of action

Active Publication Date: 2013-07-17
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, nasal administration has certain disadvantages, such as inaccurate quantification, incomplete absorption, and uneven distribution of drugs.

Method used

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  • Sublingual pharmaceutical composition containing ibutilide and preparation method thereof
  • Sublingual pharmaceutical composition containing ibutilide and preparation method thereof
  • Sublingual pharmaceutical composition containing ibutilide and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Preparation Process:

[0033] (1) Pass the main ingredient through a 100-mesh sieve, and pass the rest of the excipients through a 80-mesh sieve for later use.

[0034] (2) Mix the main ingredient and auxiliary materials uniformly by incremental dilution method, add binder to make soft material, pass through 30 mesh sieve to granulate, and dry in a ventilated drying oven at 50°C.

[0035] (3) Take out the dry granules and pass through a 24-mesh sieve for granulation, add magnesium stearate and mix evenly, measure the content of intermediates, and compress into tablets.

Embodiment 2

[0038] Preparation Process:

[0039] (1) Pass the principal ingredient and stearic acid through a 100-mesh sieve respectively, and pass the remaining auxiliary materials through a 60-mesh sieve.

[0040] (2) Mix the main drug and auxiliary materials uniformly by the incremental dilution method, and press the marked amount into tablets.

Embodiment 3

[0043] Preparation Process:

[0044] (1) Pass the main ingredient and sodium stearate fumarate through a 100-mesh sieve respectively, and pass the rest of the auxiliary materials through a 40-mesh sieve.

[0045] (2) Mix the main drug and auxiliary materials uniformly by the incremental dilution method, and press the marked amount into tablets.

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Abstract

The invention provides a sublingual pharmaceutical composition containing ibutilide and belongs to the technical field of medicine. The composition contains active component ibutilide or salt thereof and officinal excipient. The ibutilide sublingual pharmaceutical composition is 10-500 mg for per preparation, preferably 50-250 mg and more preferably 80-150 mg, and contains 0.0435-5.22 mg of main drug ibutilide or salt thereof (calculated by ibutilide), preferably 0.087-4.35 mg and more preferably 0.174-2.175 mg. The drug can be rapidly absorbed after administration and has advantages of fast effectiveness, accurate quantity and convenience for usage, so as to avoid first-pass effect of oral medicament and substantially increase bioavailability and curative effect. The production technology for preparing sublingual tablet is stable, repeatable and at low cost, can be used for industrialized production and has good clinic usage value and social benefits. The sublingual administrated preparation provided by the invention is used for treating arrhythmia.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an antiarrhythmic pharmaceutical composition, in particular to a sublingual preparation containing ibutilide. Background technique [0002] In recent years, with the rapid rise of cardiovascular diseases, the incidence of arrhythmia has increased correspondingly, accounting for about 20% of cardiovascular diseases. There are many types of arrhythmias, which can be roughly divided into rapid heart rhythm, Chronic heart rhythm and irregular early contraction into three categories. The common manifestations of fast heart rhythm are upper ventricular tachycardia, atrial flutter, atrial fibrillation and ventricular tachycardia, while slow heart rhythm is mainly caused by sinus node disease and atrioventricular conduction disorder. [0003] The direct fatal effect of arrhythmia is less, but it is often accompanied by the risk of cardiovascular embolism or disability after stroke. The i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/18A61K9/20A61P9/06
Inventor 李洪起任晓文徐为人连潇嫣王博
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH