Enteric Hard Capsule Banding Solution for Gastric Acid Resistance
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Solution Overview
Problem
Enteric hard capsules face structural issues where the coupling portion between the capsule upper and lower portions can swell and separate due to gastric acid exposure, leading to premature release of active ingredients during stomach transit.
Innovation Solution
A banding solution comprising purified water, alginate, corn starch-based polymer, and pectin is applied to the coupling portion of the capsule to enhance acid resistance and prevent swelling, ensuring the capsule remains intact during gastric acid exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If enteric hard capsules are manufactured using conventional methods, then manufacturing cost and ease of manufacture are improved, but the capsule coupling portion swells and separates due to gastric acid exposure
Solution Approach 1:
A banding solution is applied to the coupling portion of the hard capsule before the capsule is exposed to gastric acid in the stomach. This preliminary application of the banding material prevents swelling and separation by creating a protective barrier that resists gastric acid, thereby maintaining capsule integrity without requiring complex manufacturing changes
Solution Approach 2:
The banding material acts as an intermediary substance between the capsule shell and the gastric acid environment. This intermediate layer absorbs the harmful effects of gastric acid exposure, preventing direct contact between the acid and the capsule coupling portion, thus preventing swelling and separation while maintaining the capsule's structural integrity
2Device complexity
If the capsule coupling portion is exposed to gastric acid, then the capsule can be manufactured simply, but water-soluble components absorb moisture causing swelling and separation at the coupling site
Solution Approach 1:
The banding solution is applied specifically to the coupling portion of the capsule rather than the entire capsule surface. This localized application provides targeted protection at the vulnerable coupling site where swelling and separation occur, while maintaining the simplicity of the overall capsule structure and composition elsewhere
3Reliability
If a banding solution is applied to prevent capsule separation, then capsule integrity is improved, but manufacturing process complexity increases
Solution Approach 1:
The banding solution is applied to the coupling portion during the capsule manufacturing process, before the capsules are filled and sealed. This preliminary application integrates smoothly into existing manufacturing workflows, adding minimal complexity while significantly improving capsule integrity by preventing gastric acid-induced separation
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 effectively prevents the separation of the capsule upper and lower portions, maintaining the integrity of the enteric hard capsule and ensuring controlled release of the active ingredient in the intestines, while being economically viable and easy to integrate into existing manufacturing processes.
Implementation Method 1
hard capsule sites in contact with gastric acid swell because water-soluble components absorb moisture
Data Source
AI summary
The present invention relates to a banding solution for manufacturing enteric hard capsules and an enteric hard capsule manufactured using the same, and specifically, relates to banding solution for manufacturing enteric hard capsules, which prevent the generation of a gap between the coupled capsule upper portion and capsule lower portion due to gastric acid or the separation of the capsule upper portion and the capsule lower portion during the time the enteric hard capsules stay in the stomach, and an enteric hard capsule subjected to banding treatment using the same.