Enteric Soft Capsule Shell Composition for Leak-Resistant Forming
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Solution Overview
Problem
Existing enteric soft capsules face issues with poor solubility, gelatin crosslinking, limited applications due to animal-derived gelatin use, and poor formability in gellan gum systems, leading to uneven ribbons and oil leakage.
Innovation Solution
A soft capsule shell composition comprising 1.5 to 5 wt% gellan gum with specific viscosity, 30 to 40 wt% starch, and 10 to 25 wt% plasticizer, with 0 to 3 wt% starch granules, forms a network structure that resists gastric acid and disintegrates in intestinal fluid, eliminating the need for coating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If gelatin and glycerin are used as main components of the soft capsule shell, then the shell has good flexibility and sealing properties, but the capsule deforms during filling and shows sticking and adhesion
Solution Approach 1:
The patent modifies the chemical composition parameters of the shell material by introducing specific additives (sugar alcohol, polyethylene glycol, sorbitan ester) to change the physical properties of the gelatin-glycerin system, reducing deformation and adhesion while maintaining sealing properties
Solution Approach 2:
The patent creates a composite shell material by combining gelatin with multiple other components (glycerin, sugar alcohol, polyethylene glycol, sorbitan ester) in specific ratios, achieving a material that simultaneously provides flexibility, reduces deformation, and prevents sticking
2Strength
If gelatin and glycerin are used as main components of the soft capsule shell, then the shell has good flexibility and sealing properties, but the capsule shows sticking and adhesion during storage
Solution Approach 1:
The patent converts the inherently sticky nature of gelatin-glycerin shells into a benefit by carefully controlling the degree of adhesion through additive selection, allowing the shell to maintain flexibility and sealing while preventing harmful sticking during storage and handling
Solution Approach 2:
The patent adjusts the chemical composition parameters by adding specific substances (sugar alcohol, polyethylene glycol, sorbitan ester) that modify the surface properties and intermolecular forces of the shell material, reducing unwanted adhesion while preserving necessary sealing characteristics
3Ease of manufacture
If the soft capsule shell is made with conventional materials, then the capsule can be easily manufactured, but the disintegration time is long and drug release is delayed
Solution Approach 1:
The patent modifies the shell composition parameters to include components that affect water interaction and structural breakdown, enabling the shell to maintain ease of manufacture while achieving faster disintegration and earlier drug release through controlled hydrolysis and structural collapse
4Stability of the object's composition
If gelatin and glycerin are used as main components, then the shell provides good flexibility, but the capsule shows deformation during filling and storage
Solution Approach 1:
The patent adjusts the compositional parameters of the shell by incorporating sugar alcohol, polyethylene glycol, and sorbitan ester in specific proportions to modify the viscoelastic properties of the gelatin-glycerin matrix, maintaining flexibility while reducing permanent deformation during filling and 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
The composition achieves high rupture resistance and enteric release, suitable for industrial production, with improved strength, toughness, and seam adhesive properties, meeting disintegration time limits without gelatin or pectin.
Implementation Method 1
The liquid granulate is filled into the soft capsule shell through liquid filling
Implementation Method 2
A soft capsule shell according to the invention provides a good encapsulation of a liquid granulate
Data Source
Figure 1~2
Figure 3
AI summary
The present invention relates to a soft capsule shell and a soft capsule. The present invention provides a soft capsule shell prepared from a film-forming composition comprising 1.5 to 5 wt% of a first gelling agent, 30 to 40 wt% of a starch, 10 to 25wt% of a plasticizer and 35 to 55 wt% of water, wherein the first gelling agent is a gellan gum with the following properties: the gellan gum solution obtained by dissolving 1.5 wt% of the gellan gum in water at 90°C for 30 minutes has a viscosity ranging from 10 to 60 mPa.s as measured by a rotational viscometer, wherein the soft capsule shell comprises 0 to 3 wt% of starch granules, and the starch granules are those with an average particle size of 10 microns to 50 microns. The invention provides the soft capsule shell with the enteric effect, and its disintegration time limit conforms to the regulations of domestic and foreign pharmacopoeia.