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Formulation with reduced hygroscopicity

A technology of alkali metals and alkaline earth metals, applied in medical preparations of non-active ingredients, anesthetics, digestive system, etc.

Inactive Publication Date: 2013-07-24
BAYER IP GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Based on the prior art, the aim is therefore to develop a formulation of a hygroscopic solid substance and a method for its production, which overcome the disadvantages of the prior art, resulting in a hygroscopic solid The preparation of substance is no longer hygroscopic

Method used

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  • Formulation with reduced hygroscopicity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Example 2: Hygroscopicity

[0070] 6.22 grams of the dry filter cake from Example 1 and 6.12 grams of dry, pure magnesium hydroxide were each packed separately into beakers as fluff. Subsequently, the beaker was placed in a larger container with a lid but not sealed, the bottom of which was covered with distilled water up to a height of 1 cm in a drying cabinet at 30°C. When any water loss occurs, it will be replenished immediately to ensure that the free water level does not change throughout the experiment period. The relative weight change of the sample based on its initial weight is determined. The result is expressed in figure 1 middle. It can be seen that, unlike dry, pure magnesium hydroxide, the formulations of the present invention have significantly reduced weight gain.

[0071] Example 3: pH final value of formulation

Embodiment 2

[0072] To confirm the final pH value after dissolution, 100 g of 0.01 M hydrochloric acid was poured into a beaker, and stirred at 400 rpm with an inclined-blade stirrer. Subsequently, 0.1 g of the solid to be identified (formulation from Example 1, and magnesium hydroxide) was added and the increase in pH was recorded (pH-meter: Calimatic 766). The result is expressed in figure 2 middle. It can be seen that the same final pH value is established in the case of pure magnesium hydroxide (Mg), as in the case of formulation (F) according to the invention, after a period of approximately 1800 s. figure 2 It was also shown that the release of magnesium hydroxide from the formulation of the invention was delayed, but the gradient was almost the same as that of pure magnesium hydroxide. The time delay here is about 300s.

Embodiment 3

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Abstract

The invention relates to formulations of hygroscopic solids with a lipophilic coating layer, and a method of production thereof.

Description

field of invention [0001] The present invention relates to formulations of hygroscopic solids with a lipophilic shell and a process for their production. Background technique [0002] Many substances used eg as pharmaceutical active substances are hygroscopic. That is, such substances have a tendency to absorb water, for example from the surrounding air. [0003] However, for some of these substances, water absorption has a negative effect on their performance, eg as pharmaceutically active substances. For example, chemical decomposition of the active substance may occur. [0004] One possibility for stabilizing such substances, disclosed in WO 2007 / 142628, consists in providing formulations of such substances comprising at least one other substance which has a higher affinity for water absorption than the active substance, so that Substances intended to be present in formulations as active substances are not exposed to moisture until a certain degree of saturation is re...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/12
CPCA61K9/5015A61K9/145A61P1/04A61P5/00A61P7/06A61P19/10A61P23/00
Inventor J·詹克M·斯坦贝克G·贝克U·范斯迪富特
Owner BAYER IP GMBH
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