Acidic DEGEE Topical Compositions Without Preservatives
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Solution Overview
Problem
Topical pharmaceutical compositions require antimicrobial preservatives to prevent microbial proliferation, which are toxic and need to be kept at low concentrations, posing challenges in ensuring effective preservation without compromising patient safety.
Innovation Solution
Topical pharmaceutical compositions are formulated with diethylene glycol monoethyl ether (DEGEE) at an acidic pH, optionally with an emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate, eliminating the need for traditional antimicrobial preservatives while maintaining preservation efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional antimicrobial preservatives are added to topical pharmaceutical compositions, then microbial proliferation is prevented, but patient safety is compromised due to toxicity
Solution Approach 1:
The patent changes the pH parameter of the formulation to an acidic range (pH 3.0-6.0), which creates an environment that prevents microbial proliferation without requiring toxic preservatives. This parameter change transforms the preservation mechanism from chemical (preservative-based) to physical-chemical (pH-based), thereby maintaining reliability while reducing harmful effects to patients
Solution Approach 2:
The patent extracts and eliminates traditional antimicrobial preservatives from the formulation, replacing them with an acidic pH environment. This removal of harmful substances while maintaining preservation function directly resolves the contradiction between effective preservation and patient safety
2Reliability
If antimicrobial preservatives are added to prevent microbial contamination, then preservation is effective, but the formulation complexity increases
Solution Approach 1:
The patent removes traditional preservative components from the formulation, simplifying the ingredient list while maintaining preservation effectiveness through pH control. This extraction of unnecessary components directly reduces formulation complexity
Solution Approach 2:
The acidic pH environment serves multiple functions simultaneously: it provides preservation against microbial contamination, maintains skin compatibility, and simplifies the overall formulation. This multi-functionality reduces the need for separate preservative systems, thereby reducing formulation complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The compositions achieve effective antimicrobial preservation without traditional preservatives, meeting European Pharmacopeia and USP criteria, ensuring safety and efficacy over the product's shelf life.
Implementation Method 1
topical pharmaceutical compositions comprising diethylene glycol monoethyl ether (DEGEE) maintained at an acidic pH were fully preserved without the addition of a traditional antimicrobial preservative
Data Source
AI summary
Topical pharmaceutical compositions comprising diethylene glycol monoethyl ether (DEGEE) maintained at an acidic pH. The pH of the formulation can be maintained at a pH of less than 6.3, or alternatively less than 6.0. Certain pharmaceutical composition further comprise an emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate, which is manufactured by Croda under the tradename Crodafos™ CES.