Enteric Softgel Capsule Shell Composition and Method
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Solution Overview
Problem
Existing enteric dosage forms face issues with uneven coating, cracking, flaking, and leakage due to the need for enteric coatings or conventional enteric polymers, which are inefficient and prone to defects.
Innovation Solution
Enteric softgel capsules with a gelatin-based shell composition that includes hydroxypropyl methyl cellulose (HPMC) and low methoxy pectin, eliminating the need for enteric coatings or conventional polymers, ensuring stability in gastric environments and dissolution in intestinal fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an enteric coating is applied to the surface of a capsule, then the capsule gains enteric properties to protect contents from gastric conditions, but the coating process is inefficient and leads to rough appearance, uneven coating, cracking, and flaking
Solution Approach 1:
The patent combines the enteric polymer directly into the capsule shell formulation rather than applying it as a separate coating layer. The shell composition integrates enteric polymers (such as cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, or polyvinyl acetate phthalate) with gelatin and plasticizers to create a unified structure that provides enteric protection inherently, eliminating the need for separate coating operations and avoiding coating defects
Solution Approach 2:
The patent uses composite shell compositions that combine gelatin with enteric polymers and plasticizers. This composite approach creates a material that possesses both the structural properties of gelatin and the enteric resistance of the polymer components, achieving reliable gastric protection while maintaining manufacturing efficiency and capsule integrity
2Reliability
If conventional enteric polymers are added in the capsule shell, then enteric properties are achieved, but the capsules become prone to leaking due to insufficient sealing
Solution Approach 1:
The patent modifies the formulation parameters of the capsule shell by incorporating specific ratios of gelatin, enteric polymers, and plasticizers. By adjusting these compositional parameters and processing conditions, the shell achieves both adequate enteric resistance and sufficient sealing strength to prevent leakage, resolving the contradiction between enteric properties and sealing integrity
3Reliability
If an enteric coating is applied through spraying and drying at elevated temperatures, then enteric protection is achieved, but the process is very inefficient and time-consuming
Solution Approach 1:
The patent incorporates the enteric polymer into the capsule shell during the initial shell formation process rather than applying it as a subsequent coating step. This preliminary integration eliminates the need for separate spraying and drying operations, significantly reducing process time while maintaining effective enteric protection
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 provides stable enteric softgel capsules that maintain integrity in gastric conditions and effectively release active ingredients in intestinal environments, reducing stomach irritation and improving bioavailability without the drawbacks of traditional coatings or polymers.
Implementation Method 1
the gelatin-based shell compositions of the present invention possessed enteric properties without the need to apply an enteric coating or incorporate a conventional enteric polymer
Implementation Method 2
dissolve in the intestines
Data Source
AI summary
Enteric softgel capsules comprise a fill material and an enteric shell composition, characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.