Enteric Coating Composition with Ammoniated Shellac and Polymer
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Solution Overview
Problem
Current enteric coating technologies face challenges in ensuring pharmaceutical and nutraceutical dosage units remain intact in the stomach and release their contents effectively in the intestines, particularly for unstable ingredients that degrade in acidic environments.
Innovation Solution
An enteric coating composition comprising 0.01% to 8% ammoniated shellac and 0.01% to 8% polymer, such as alginates, with a total resin content of less than 15%, providing a delayed release profile that meets USP testing methods using food and drug-approved materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional enteric coating materials are used to protect dosage units from stomach acid, then the coating provides acid resistance and delayed release, but the coating may not provide sufficient protection for highly unstable ingredients or may not meet specific release profile requirements
Solution Approach 1:
The patent employs composite coating formulations combining multiple polymers (e.g., cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, polyvinyl alcohol) with specific resin and polymer content ratios (0.01% to 10% each). This composite approach creates coatings with enhanced and tunable acid resistance and release profiles, allowing customization for different ingredient stability requirements and target release locations in the gastrointestinal tract.
2Stability of the object's composition
If enteric coating is applied to ensure ingredient stability in stomach acid, then the coating dissolves in alkaline conditions for intestinal release, but the coating composition and application parameters must be precisely controlled to achieve consistent results
Solution Approach 1:
The patent specifies precise parameter ranges for coating formulation (resin content 0.01%-10%, polymer content 0.01%-10%, total solids 10%-20%) and application conditions (coating pan temperature 25°C-40°C, spray rate 0.5-2 mL/min, coating thickness 1-10 micrometers). These controlled parameter changes enable consistent coating performance and reliable enteric protection across different manufacturing batches while accommodating variations in substrate characteristics.
3Reliability
If the coating composition includes resins and polymers for enteric properties, then the coating provides delayed release functionality, but the total resin and polymer content must be limited to maintain coating flexibility and prevent brittleness
Solution Approach 1:
The patent establishes specific concentration ranges for resin (0.01%-10%) and polymer (0.01%-10%) components, with total solids content controlled at 10%-20%. By adjusting these parameters within defined ranges, the formulation achieves optimal balance between enteric functionality (requiring sufficient resin/polymer for acid resistance) and mechanical properties (requiring limited content to maintain flexibility and prevent coating brittleness).
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 coating composition effectively protects dosage units from stomach acid, ensuring delayed release in neutral or mildly alkaline conditions, providing a controlled release profile and meeting regulatory standards for enteric coatings.
Implementation Method 1
Enteric coating materials are generally acid resistant, thus protecting and preventing a dosage unit from releasing its contents into the stomach
Implementation Method 2
These coatings dissolve or disintegrate in the neutral or mildly alkaline conditions of the gastrointestinal tract beyond the stomach
Data Source
Figure 1
AI summary
An enteric coating composition including about 0.01 % to about 10% resin and about 0.01 % to about 10% polymer. The enteric coating composition may be applied to a substrate, such as a pharmaceutical, nutraceutical, fruit, vegetable, agricultural product, or industrial product, to form an enteric coating on the substrate. Also provided is a multiple-component system having a first component including a resin and a second component including a polymer, wherein mixing the first component and the second component forms an enteric coating composition having about 0.01 % to about 10% resin and about 0.01 % to about 10% polymer. Methods for coating a substrate with the enteric coating compositions are also provided.