Novel galenic system for active principle transport, preparation method and use

A technology of active ingredients and systems, applied in the field of new drug systems, can solve problems such as instability of active ingredients, inability to solve the problem of taste masking, etc., and achieve the effect of delayed release

Inactive Publication Date: 2008-01-16
欧哈朗斯药物
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] For liquid dosage forms, the application is convenient, but such dosage forms always suffer from unresolved problems of taste masking and instability of many active ingredients in the aqueous phase

Method used

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  • Novel galenic system for active principle transport, preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0119] Example 1: Preparation of omeprazole-containing particles with a melting point of 35°C

[0120] An example for the manufacture of 100 g of omeprazole-containing particles is given:

[0121] Composition TG1:

[0122] 79g of a saturated triglyceride mixture with a melting point of 35°C

[0123] (Captex from ABITEC  )

[0124] Sodium bicarbonate 1g

[0125] Omeprazole 20g

[0126] The method used to prepare the particles:

[0127] In a constant temperature container, the compound with the highest melting point is heated to a temperature 2°C above its melting point, and then the compounds with melting points from the highest to the lowest are added in sequence.

[0128] The temperature of the mixture was gradually reduced to maintain the temperature at 5°C above the melting point of the fresh mixture.

[0129] Omeprazole was added last. These components were dispersed in the lipid phase with the aid of a Turrax brand turbine type agitation system at 10000 rpm. Th...

Embodiment 2

[0135] Example 2: Preparation of Omeprazole-containing Particles with a Melting Point of 35°C Without an Alkalinizing Agent

[0136] An example for making 100 g of particles is given:

[0137] Composition TG2:

[0138] Saturated triglyceride mixture with a melting point of 35°C 80g

[0139] (Captex from ABITEC  )

[0140] Omeprazole 20g

[0141] Particles were prepared as described in Example 1.

Embodiment 3

[0142] Example 3: Preparation of omeprazole-containing particles with a melting point equal to 38°C

[0143] An example for making 100 g of particles is given:

[0144] Composition TG3:

[0145] Glycerin with capric, caprylic and lauric acids with a melting point of 38°C 79g

[0146] Triester

[0147] Sodium bicarbonate 1g

[0148] Omeprazole 20g

[0149] Particles were prepared as described in Example 1.

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Abstract

The invention concerns a novel galenic system with prolonged stability. Said system enables an active principle to be protected, in particular a drug, against degradation while passing through the stomach upon oral absorption. In particular, the invention concerns a galenic system, in the form of strictly hydrophobic solid lipid particles, not containing any water, surfactants, emulsifying agents, solvent traces, characterized in that it comprises at least one active principle, at least one hydrophobic wax and at least one agent neutralizing the embedded active principle.

Description

technical field [0001] The present invention relates to novel drug systems whose stability is prolonged. Said system makes it possible to protect the active ingredient, in particular the drug, from degradation when it passes through the stomach when it is absorbed by the oral route. [0002] According to the pharmaceutical system of the present invention, it is also possible to cover the taste of the active ingredients optionally contained in the pharmaceutical system, to stabilize the active ingredients, to adjust the release properties of the active ingredients, to mask the irritating effect and toxicity of certain active ingredients on the mucous membrane . Background technique [0003] The simplest and most practical route of therapeutic administration remains the oral route. In France, oral administration accounts for 75% of the modes of drug administration (Phamacie galénique, A. Le Hir-Edition Masson). There are two main dosage forms for the oral route, liquid and ...

Claims

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Application Information

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IPC IPC(8): A61K9/16
CPCA61K9/1694A61K9/1617A61K9/16A61K9/14
Inventor 卡里姆·尤阿拉朗罗萨内·雷纳尔
Owner 欧哈朗斯药物
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