pH-Responsive Coated Basis Particles for Orally-Disintegrating Tablets
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Solution Overview
Problem
Conventional orally-disintegrating tablets often fail to effectively mask bitterness and ensure consistent drug elution across varying pH levels in the stomach, particularly in achlorhydric patients, leading to delayed or insufficient drug release.
Innovation Solution
Basis particles coated with a water-insoluble film containing an acidic or basic substance to adjust pH locally and mask bitterness, combined with a water-soluble primary coating film, allowing for superior drug elution independent of bodily pH.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a water-insoluble coating film is applied to mask bitterness, then bitterness masking is improved, but drug elution is delayed or insufficient at pH 5.0 or higher
Solution Approach 1:
The patent applies parameter changes by incorporating pH-modifying substances (acidic or basic) into the water-insoluble coating film. This allows the coating to dynamically adjust its properties in response to pH changes in the gastrointestinal tract, ensuring that the film remains intact for bitterness masking in the mouth but becomes permeable for drug elution in the stomach and intestines where pH varies.
2Object-affected harmful factors
If a water-insoluble coating film is used to suppress bitterness, then taste masking is improved, but elution reliability deteriorates in achlorhydric patients with high stomach pH
Solution Approach 1:
The patent implements dynamics by creating a coating film that dynamically responds to pH changes. The inclusion of pH-modifying substances enables the coating to adapt its permeability characteristics based on the local pH environment, transforming a static barrier into a dynamic system that ensures drug release regardless of the patient's gastric pH conditions.
3Ease of manufacture
If conventional coating methods are applied, then manufacturing simplicity is maintained, but elution delays occur depending on drug characteristics and pH conditions
Solution Approach 1:
The patent employs composite materials by combining water-insoluble coating agents with pH-modifying substances (acids or bases) within the same coating matrix. This composite structure maintains the ease of application of conventional coating methods while introducing pH-responsive functionality that ensures consistent drug elution across different gastrointestinal pH conditions.
Data Source
Figure 1A~1B
Figure 2A~2B
AI summary
A basis particle comprises a basic or acidic basis particle coated by a water-insoluble coating film, wherein the water-insoluble coating film contains a substance that is acidic with respect to the basic basis or basic with respect to the acidic basis. According to the basis particles (i.e., a main ingredient or an active drug)of the present invention, it is possible to temporarily adjust pH occurring in the immediate proximity of the basis particles by using a coating film, elution of the basis particles is suppressed and superior elution is exhibited without dependence on bodily pH. It is also possible to mask tastes such as the bitterness of the basis and it is possible to ingest drugs without sensing any bitterness.