Bromhexine Aqueous Composition Stability and Taste Masking

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Solution Overview

Problem

Bromhexine-containing compositions face stability issues during storage, leading to decomposition and a bitter taste, which complicates their use in film packaging and dosage forms.

Innovation Solution

An aqueous composition with bromhexine, sugar alcohols in less than 10g per 100ml, a thickener, sweetener, and other additives like preservatives and flavorings, providing a low decomposition rate and masking the bitter taste, suitable for film packaging and effective secretory therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If sugar alcohols are added to stabilize bromhexine-containing compositions, then the stability of bromhexine is improved, but the amount of sugar alcohols required (more than 10g per 100ml) results in increased viscosity and altered mouthfeel

Engineering Contradiction:
Improvestability of bromhexineVSAvoidmouthfeel and viscosity
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent changes the concentration parameter of sugar alcohols from the conventional more than 10g per 100ml to less than 10g per 100ml. This parameter change maintains the stabilizing effect on bromhexine while avoiding excessive viscosity and preserving acceptable mouthfeel characteristics.

Inventive Principle:
Principle #35Parameter changes

2Object-generated harmful factors

If high amounts of sugar alcohols (>10g per 100ml) are used to mask the bitter taste of bromhexine, then the taste masking is improved, but the composition becomes too viscous and unsuitable for certain dosage forms

Engineering Contradiction:
Improvebitter taste of bromhexineVSAvoidviscosity and suitability for film packaging
Core Design Contradiction:
Object-generated harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent optimizes the sugar alcohol concentration parameter to less than 10g per 100ml, which provides sufficient taste masking while maintaining appropriate viscosity levels that enable film packaging and other dosage forms.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent combines sugar alcohols with other excipients (thickeners, sweeteners, preservatives) in specific amounts to create a composite composition that achieves taste masking and stability without relying on excessive sugar alcohol content alone.

Inventive Principle:
Principle #40Composite materials

3Stability of the object's composition

If reducing agents and chelating complexing agents are added to stabilize bromhexine, then the decomposition rate is reduced, but the composition complexity and number of additives increase

Engineering Contradiction:
Improvedecomposition rate of bromhexineVSAvoidnumber of additives
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent extracts or removes the need for reducing agents and chelating complexing agents from the composition. By using only sugar alcohols in optimized amounts (less than 10g per 100ml), the patent achieves stable bromhexine without these additional stabilizing agents, thereby simplifying the composition.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentEP2593094B1Aqueous composition comprising bromhexine
Publication Date: 2017.12.06 SANOFI AVENTIS DEUT GMBH

AI summary

The present invention relates to aqueous compositions comprising bromhexine, the composition containing an amount of sugar alcohols of less than 10 g based on 100 ml of the composition, and to the use thereof for secretolytic therapy in acute and chronic bronchopulmonary disorders.