Alginate-PVA Enteric Coating for Solvent-Free Film Application
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Solution Overview
Problem
Current enteric coating materials for pharmaceutical and food applications face challenges such as the use of organic solvents, inadequate performance, and the inclusion of phthalates, which require additional processing steps and are not approved for food use, while existing alginate-based coatings lack sufficient mechanical strength and stability in acidic conditions.
Innovation Solution
A food-safe, phthalate-free, water-soluble dry powder formulation comprising a specific ratio of alginate to film formation polymer, such as sodium alginate and polyvinyl alcohol-polyethylene glycol graft copolymer, which forms a coating that remains insoluble in gastric juices and dissolves in intestinal conditions, ensuring the active ingredient is released effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If organic solvents are used in enteric coating materials, then coating performance is improved, but pollution increases and fire/explosion danger increases
Solution Approach 1:
The patent changes the solvent parameter from organic to aqueous (water-based), transforming the coating composition into an environmentally friendly system while maintaining enteric functionality through the selection of appropriate water-soluble polymers
Solution Approach 2:
The patent replaces expensive and hazardous organic solvents with cheap, non-hazardous water, eliminating the need for specialized equipment and training while achieving the same coating function
2Reliability
If phthalates are used in enteric coating, then enteric functionality is achieved, but additional processing steps are required and food use approval is not obtained
Solution Approach 1:
The patent extracts and eliminates phthalates from the coating system, replacing them with non-phthalate polymers that provide equivalent enteric functionality without requiring neutralization or acid treatment steps
Solution Approach 2:
The patent uses polymers that inherently provide enteric functionality without requiring additional processing steps such as neutralization with ammonia or acid treatment, making the system self-sufficient and suitable for food applications
3Strength
If high G content alginate is used in coating, then mechanical strength is improved, but viscosity increases and processing becomes difficult
Solution Approach 1:
The patent changes the G content parameter of alginate from high to low (20-40%), which reduces viscosity and improves processability while compensating for the loss in mechanical strength through optimization of other formulation parameters
Solution Approach 2:
The patent creates a composite coating system combining low G content alginate with film formation polymers and plasticizers, where the synergistic interaction of components compensates for the reduced mechanical strength of individual ingredients
4Ease of operation
If alginate-based coating is used, then water solubility is improved, but enteric performance becomes inadequate
Solution Approach 1:
The patent develops a composite coating system combining alginate with film formation polymers and plasticizers, where the synergistic interaction provides both water solubility and adequate enteric performance that neither component achieves alone
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 formulation provides a stable enteric coating that prevents release in acidic environments for up to one hour and releases the active ingredient efficiently in neutral conditions, meeting the requirements for pharmaceutical, nutraceutical, veterinary, and food applications without the need for organic solvents or strong acids.
Implementation Method 1
the alginate is water soluble at 10% solids and has a G content of 20% to 40%... the active ingredient is not released into a medium of 0.1 N HCl at about 37°C for up to one hour and thereafter about 90% or more of the active ingredient is released within two hours in a phosphate buffer medium having pH 7.2
Data Source
AI summary
A food safe, plant based, water soluble, dry powder formulation and an aqueous enteric coating solution made therefrom, that is used for providing an enteric film coating on oral dosage forms including capsules, tablets, and the like; and methods of making the dry powder formulation, making the aqueous coating solution, and coating of oral dosage forms including capsules, tablets, and the like.