Extruded Chewable Formulation Without Free Water
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Solution Overview
Problem
Chewable formulations with high water content face issues such as microbial contamination, degradation of active ingredients, and poor texture, while low water content leads to dry or crumbly products and difficulties in extrusion, making it challenging to create a formulation that is both palatable and shelf-stable.
Innovation Solution
A shelf-stable chewable formulation is developed through extrusion without the addition of water, containing a nutritional or pharmaceutically active agent and a plasticizer, with a water activity range of 0.1 to 0.65, using a method that mixes the agent with fat or lipid, adds plasticizers, and extrudes under conditions to melt the fat, thereby forming a stable product without free water.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If water is added to chewable formulation, then palatability and extrusion processability are improved, but microbial contamination and degradation of active ingredients occur
Solution Approach 1:
The patent removes water from the formulation entirely, using alternative plasticizing agents (glycerol, propylene glycol, or a combination) to achieve the desired plasticizing effect without introducing water, thereby preventing microbial contamination while maintaining extrusion processability
Solution Approach 2:
The patent changes the chemical composition parameters by replacing water with non-aqueous plasticizing agents, adjusting the formulation to achieve comparable plasticizing effects through different chemical mechanisms that do not support microbial growth
2Ease of operation
If water is added to chewable formulation, then texture and palatability are improved, but degradation of active ingredients occurs
Solution Approach 1:
The patent extracts water from the system and replaces it with water-miscible plasticizing agents that provide similar plasticizing effects without the water activity that drives chemical degradation, thereby maintaining texture while improving stability
Solution Approach 2:
The patent introduces water-miscible plasticizing agents as intermediary substances that mediate between the need for plasticizing (for texture and processability) and the need to avoid water (for stability), providing a bridging solution that achieves both goals
3Reliability
If water is reduced in chewable formulation, then microbial contamination and degradation are prevented, but product becomes dry or crumbly
Solution Approach 1:
The patent changes the formulation parameters by substituting water with alternative plasticizing agents that provide comparable plasticizing effects through different chemical mechanisms, maintaining product coherence without water
Solution Approach 2:
The patent uses composite plasticizing systems combining glycerol and/or propylene glycol with other formulation ingredients to achieve the desired plasticizing effect and product coherence through synergistic interactions between multiple components
4Stability of the object's composition
If water is reduced in chewable formulation, then chemical stability is improved, but extrusion processability deteriorates
Solution Approach 1:
The patent adjusts the formulation parameters by incorporating water-miscible plasticizing agents in optimized quantities and ratios, changing the chemical composition to achieve both chemical stability and extrusion processability simultaneously
Solution Approach 2:
The patent employs plasticizing agents that perform multiple functions: they provide plasticizing for extrusion processability, maintain product coherence, and avoid water-related stability issues, serving multiple purposes with a single ingredient strategy
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 solution results in a stable, palatable, and microbiologically resistant chewable treat that maintains chemical stability and texture, preventing hardening and microbial contamination, while allowing for effective delivery of active ingredients.
Implementation Method 1
extruding the first composition or second composition under conditions effective to at least partially melt the fat, lipid, or fat and lipid
Implementation Method 2
a plasticiser... used conditions effective to at least partially melt the fat, lipid, or fat and lipid, thereby providing the chewable formulation
Data Source
AI summary
The present invention relates to a chewable formulation for delivering a nutritional or pharmaceutically active agent to an animal target. The chewable formulation comprises a nutritional ingredient or an effective amount of a pharmaceutically active agent, and a plasticizer. The chewable formulation is formed by extrusion and the formulation contains substantially no unbound water, nor is any water added in the manufacturing process. The present invention also relates to a method of manufacturing a shelf stable chewable formulation which comprises mixing the nutritional or pharmaceutically active agent with a fat, lipid or fat and lipid to obtain a first composition, adding one or more plasticizers to the first mixture to obtain a second composition, extruding the second composition at a temperature sufficient to melt the fat and lipid, and allowing the extruded second composition to cool to room temperature thereby providing the chewable formulation.