Semi-Soft Solid Dosage Form Manufacturing Process
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Solution Overview
Problem
Existing soft chew formulations face issues with stability due to improper composition, temperature, and the use of polyethylene glycol (PEG), which can affect the efficacy of active ingredients and cause bitter taste, while also leading to oxidative degradation and segregation of oils.
Innovation Solution
A process for manufacturing semi-soft solid dosage forms that excludes PEG and oils, involving blending active ingredients with excipients and solid fats at low temperatures to create a dough that can be shaped and packaged, using ingredients like starch, glycerin, and lecithin, and optionally including flavorings and sweeteners.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If vegetable oils are used as inactive ingredients in soft chew formulations, then the dough can be formed and shaped, but oxidative degradation of active ingredients occurs during storage and at higher temperatures
Solution Approach 1:
The patent removes vegetable oils from the formulation entirely, replacing them with alternative inactive ingredients such as starches, sugars, and humectants that do not promote oxidative degradation. This extraction of the harmful component (oil) eliminates the oxidation risk while maintaining the dough-forming capability through other binders and fillers.
Solution Approach 2:
The patent changes the chemical composition parameters of the formulation by substituting oil-based components with non-oil alternatives. This parameter change in the ingredient composition fundamentally alters the oxidation pathway, preventing the degradation of active ingredients during storage.
2Ease of manufacture
If PEG is used in soft chew formulations, then the dough can be formed and processed, but bitter taste is imparted to the finished product
Solution Approach 1:
The patent removes PEG from the formulation, eliminating the source of bitter taste. Alternative inactive ingredients such as starches, sugars, and flavoring agents are used instead to provide the necessary dough properties without imparting unwanted taste characteristics to the finished soft chew.
3Ease of manufacture
If high process temperature is used during manufacturing, then the dough can be formed and shaped, but thermo-labile active ingredients are degraded
Solution Approach 1:
The patent changes the processing temperature parameter from high to low temperature manufacturing. This parameter change protects thermo-labile active ingredients from degradation while still allowing the dough to be formed and shaped through modified formulation ingredients that provide adequate binding and plasticity at lower temperatures.
4Ease of manufacture
If water is included in the composition, then the dough can be formed, but moisture-sensitive functional ingredients are affected
Solution Approach 1:
The patent changes the water content parameter by using alternative humectants and binding agents such as glycerin, sorbitol, or starch-based binders that provide the necessary dough formation properties with reduced free water activity. This parameter change protects moisture-sensitive functional ingredients while maintaining manufacturability.
5Ease of manufacture
If oxidation-triggering ingredients are included in the composition, then the dough can be formed, but stability of oxidation-prone active ingredients is affected
Solution Approach 1:
The patent removes oxidation-triggering ingredients from the formulation and replaces them with antioxidants or inert fillers that do not promote oxidation. This extraction eliminates the chemical pathways that would degrade oxidation-prone active ingredients during storage.
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
This method allows for the production of palatable soft chews without PEG, maintaining ingredient stability and preventing oxidative degradation, while enabling low-temperature processing and versatility in formulations, ensuring effective delivery of active agents.
Implementation Method 1
adding solid fat melted to at least 40° C.
Implementation Method 2
blending these ingredients to form a dough at a temperature below 35° C.
Data Source
AI summary
The invention relates to semi-soft dosage forms with functional health ingredients for animal as well as human use.