EMD Formulation pH Stability via Sterilized PGA Molecular Weight
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Solution Overview
Problem
Current formulations of enamel matrix derivative (EMD) proteins with propylene glycol alginate (PGA) suffer from rapid pH decrease due to PGA degradation, leading to instability and requiring storage at low temperatures, which limits their shelf life and practical application.
Innovation Solution
Formulations with sterilized PGA having a weight average molecular weight of 250-500 kDa, obtained through e-beam sterilization, exhibit enhanced stability and pH stability over time, allowing for longer shelf life and reduced temperature sensitivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional PGA with lower molecular weight is used in EMD formulations, then the formulation can be manufactured more easily, but the pH stability deteriorates rapidly over time
Solution Approach 1:
The patent applies parameter changes by specifying a minimum weight average molecular weight of 130 kDa for PGA, which fundamentally alters the degradation kinetics and pH stability profile of the formulation, resolving the contradiction between ease of manufacture and pH stability
Solution Approach 2:
The patent creates a composite system by combining EMD proteins with high molecular weight PGA (≥130 kDa), where the specific molecular weight parameter of PGA determines the overall stability characteristics of the composite formulation
2Use of energy by stationary object
If PGA degradation is allowed to proceed, then the formulation can be stored at lower costs, but the pH decreases rapidly leading to instability
Solution Approach 1:
By changing the molecular weight parameter of PGA to at least 130 kDa, the patent slows down the degradation rate, allowing the formulation to maintain pH stability at higher storage temperatures without requiring expensive refrigeration
3Stability of the object's composition
If EMD formulations are stored at low temperatures, then pH stability is maintained, but shelf life and practical application are limited
Solution Approach 1:
The patent changes the storage temperature parameter from refrigerated (2-8°C) to ambient temperatures (up to 25°C or higher) by using high molecular weight PGA, thereby extending practical shelf life and improving accessibility without compromising pH stability
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 use of high molecular weight sterilized PGA in EMD formulations results in more stable products with improved pH stability, enabling storage at higher temperatures and extending the shelf life to at least 18 months with a pH value above 3.5, thus enhancing their practicality and stability.
Implementation Method 1
sterilized PGA, wherein said sterilized PGA is obtainable from e-beam sterilization of non-sterilized PGA
Data Source
AI summary
Enamel Matrix Derivative (EMD) proteins and enamel matrix proteins are widely used in clinical dentistry because of their ability to promote regeneration of soft and hard tissues and to reduce inflammation and infections. The present invention relates to the surprising finding that a pharmaceutical, dental and/or cosmetic formulation, which comprises purified Enamel Matrix Derivative (EMD) proteins and/or enamel matrix proteins and sterilized Propylene Glycol Alginate (PGA), wherein the sterilized PGA is obtained from non-sterilized PGA having a weight average molecular weight (Mwo) of between 250-500 kDa, is more stable over time, especially, the pH is more stable over time.