Enteric Hard Capsule Film via Cold Gelation
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Solution Overview
Problem
The preparation of enteric hard capsules by the coating method is complex, involving filling, sealing, and coating, which burdens manufacturers and complicates the capsule manufacturing process. Additionally, existing methods struggle to produce a hard capsule film with suitable acid resistance and film-forming characteristics for use in the immersion method.
Innovation Solution
A hard capsule film is developed using a nonionic water-soluble cellulose compound with a viscosity value between 100 mPa·s to 100,000 mPa·s, combined with an enteric methacrylic acid copolymer, an enteric cellulose compound, and optionally polyvinyl alcohol, a plasticizer, or a surfactant, to create a film with enteric characteristics suitable for the cold gelation method.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the coating method is used to prepare enteric hard capsules, then acid resistance is achieved, but the preparation process becomes complex and manufacturing burden increases
Solution Approach 1:
The patent combines the capsule film formation and enteric coating functions into a single integrated process. The capsule film itself is made from enteric polymer materials that provide both structural integrity and acid resistance, eliminating the need for separate coating steps. This merging of functions reduces process complexity while maintaining acid resistance performance.
Solution Approach 2:
The capsule film material is designed to serve multiple functions simultaneously: it provides mechanical strength for capsule integrity, enteric properties for acid resistance, and film-forming characteristics for proper capsule structure. This multi-functionality eliminates the need for separate specialized layers or coatings, simplifying the manufacturing process.
2Reliability
If enteric coating is applied to filled and sealed capsules, then enteric properties are achieved, but manufacturing time and operational burden increase
Solution Approach 1:
The enteric polymer material is prepared and prepared solutions are readied in advance, allowing the capsule film to be formed with enteric properties during the capsule formation process itself rather than requiring subsequent coating operations. This preliminary preparation enables parallel processing and reduces total manufacturing time.
Solution Approach 2:
The capsule formation and enteric property impartsion are merged into a single operational sequence. The capsule film is formed directly from enteric polymer solutions, combining the film-forming and enteric coating functions in one step, thereby eliminating separate coating operations and improving manufacturing efficiency.
3Reliability
If a hard capsule film with enteric properties is made, then acid resistance is improved, but film-forming characteristics and mechanical strength become difficult to achieve
Solution Approach 1:
The patent employs composite polymer systems that combine multiple materials with complementary properties. The formulation includes enteric polymers providing acid resistance alongside materials that enhance mechanical strength and film-forming characteristics. This composite approach allows simultaneous achievement of enteric properties and structural integrity.
Solution Approach 2:
The patent optimizes parameters such as polymer molecular weight, composition ratios, and processing conditions to achieve the desired balance between acid resistance and mechanical strength. By carefully controlling these parameters, the film achieves both enteric properties and sufficient mechanical strength for capsule functionality.
4Strength
If gelling agents are used to improve film performance, then film characteristics are enhanced, but the preparation process becomes more complex
Solution Approach 1:
The patent extracts and eliminates the need for separate gelling agents by incorporating film-forming capabilities directly into the enteric polymer material formulation. The polymer system itself provides the necessary film-forming properties without requiring additional gelling agents or additives, thereby simplifying the preparation process while maintaining film performance.
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 resulting enteric hard capsule film exhibits improved acid resistance and mechanical strength, allowing for efficient production without the need for gelling agents and compatibility with standard capsule filling machines, while maintaining enteric properties.
Implementation Method 1
a hard capsule film having enteric characteristics, which can be molded by a cold gelation method
Implementation Method 2
the formulation is not easily dissolved in the stomach... the formulation has such a characteristic that the formulation is easily dissolved after being transferred to the intestines
Implementation Method 3
at least one component selected from the group consisting of a polyvinyl alcohol copolymer, a plasticizer, and a surfactant
Data Source
AI summary
An object of the present disclosure is providing a hard capsule made of a hard capsule film having enteric properties that can be molded by a cold gel method. An enteric hard capsule comprises a film containing a first component and a second component, and further containing at least one component selected from the group consisting of a third component, a fourth component, and a fifth component, wherein the first component is a nonionic water-soluble cellulose compound having a viscosity value within a range of from 100 mPa·s to 100,000 mPa·s, the second component is an enteric methacrylic acid copolymer, the third component is an enteric cellulose compound, wherein the fourth component is a water-insoluble (meth)acrylic acid alkyl ester copolymer, and the fifth component is at least one kind selected from the group consisting of polyvinyl alcohol, a plasticizer, and a surfactant.