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Method for preparing stable simethicone/alverine combination

A simethicone, stable technology, applied in the field of combination of simethicone and alverine salt, can solve problems such as difficult preparation of alverine salt and simethicone

Active Publication Date: 2010-07-07
法国优德制药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, alverine salt and simethicone are difficult to formulate in a composition, so there is a need for a method for preparing a stable and uniform combination of simethicone and alverine salt

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0025] The method for preparing the combination of simethicone and alverine salt of the present invention corresponds to continuously mixing these two active ingredients.

[0026] First, in step (a), preferably under mild stirring, more preferably under planetary stirring, part of simethicone is added in the mixer.

[0027] In step (a), after adding the simethicone under gentle stirring, adjust the stirring speed to ensure that the simethicone can not be vigorously stirred. The stirring of this step (a) helps to form and keep the Simethicone liquid so as to facilitate the dispersion of Alverine to the greatest extent.

[0028] Advantageously, the amount of Simethicone added to the mixer in step (a) is 25-75wt%, preferably between 40-60%, relative to the total amount of Simethicone in the combination produced at last. More preferably, the amount of Simethicone added to the mixer in step (a) is 50% with respect to the total amount of Simethicone in the combination of the last p...

Embodiment approach

[0040] Therefore the present invention further relates to a method of producing a unit pharmaceutical composition in capsule form, preferably in the form of soft gelatin, said method comprising filling capsules with a combination of simethicone and alverine salt obtained according to the method of the present invention, preferably Soft gelatin capsules. In a particularly preferred embodiment, the method for producing the pharmaceutical composition of the present invention comprises filling soft gelatin capsules with a combination of simethicone and alverine salt in a weight ratio of 300:60, said combination according to the above Manufactured by the described preparation method.

[0041] The filling of capsules, especially soft gelatine capsules, is a method well known to those skilled in the art who will be able to apply this knowledge to formulate combinations produced according to the methods described above. Soft gelatin capsules are especially made from gelatin, which ca...

Embodiment

[0044] The method for preparing simethicone and alverine citrate combination

[0045] The following examples illustrate the preparation of a homogeneous combination of simethicone and alverine citrate in a weight ratio of 300:60.

[0046] Add 50% simethicone (135kg) in the stainless steel mixer with thermostat, equipped with planetary agitator and placed at the bottom of the tank (rotor / stator) with a thermostat in 600 liters of volume, at 7 rev / min speed for planetary mixing.

[0047] Adjust the speed of the planetary mixer to ensure that the simethicone is not stirred vigorously. This agitation helps to create and maintain the fluidity of the simethicone for optimum dispersion of the alverine citrate.

[0048] Alverine citrate (100%, ie 54 kg) was then added. Once it is added, run the rotor / stator turbine mixer placed on the bottom of the tank to facilitate the dispersion of the alverine citrate in the simethicone, continuing the planetary agitation. The turbine used i...

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Abstract

The invention relates to a method for preparing a stable simethicone and alverine combination. The invention further relates to a method for preparing a medicinal composition, in particular to a composition for treating functional digestive disorder with tympanites.

Description

technical field [0001] The invention relates to a method for preparing a stable combination of simethicone and alverine salt. The invention further relates to a process for the preparation of a pharmaceutical composition, in particular a composition for the treatment of functional digestive disorders accompanied by meteorism. Background technique [0002] Functional bowel disorder or non-organic colon disease is also referred to as functional bowel disorder or functional colon disease. They all involve disturbances in bowel motility (diarrhea, constipation, or both) with abdominal pain and flatulence (flatulence), but they have no organic etiology. The disorder can develop into long-term and recurring episodes. [0003] Bowel bloating is a distension of the abdomen caused by gas in the intestines that causes abdominal pain. It is a very common symptom of a functional bowel disorder. Bloating of the bowel is not a serious type. [0004] Alverine is an antispasmodic drug ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K31/695A61K9/66A61J3/07A61P1/14A61P1/00
Inventor B·德隆-比加尔
Owner 法国优德制药厂
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