Enteric Coated Tablet Dual-Layer Polymer System
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Solution Overview
Problem
Existing enteric coated tablets struggle to balance a large medicinal ingredient load with sufficient impact resistance and controlled drug release in the lower gastrointestinal tract, often requiring multiple tablets per dose and facing issues with acid resistance and manufacturing complexity.
Innovation Solution
The development of an enteric coated tablet with a double layer coating system, comprising a water-soluble polymer inner layer and an enteric coating layer dissolving at pH 7 or higher, where the total polymer amount is within specific ranges (10-18 mg/cm2) to achieve consistent drug release and high impact resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the thickness of the enteric coating layer is increased to accommodate a large amount of medicinal ingredient, then the medicinal ingredient load is improved, but the drug release is delayed
Solution Approach 1:
The coating is divided into two distinct layers: an inner water-soluble polymer layer and an outer enteric coating layer. This segmentation allows the inner layer to provide immediate drug release capability while the outer layer provides acid resistance, resolving the contradiction between loading capacity and release speed.
Solution Approach 2:
The patent uses a composite coating structure combining two different polymer materials with complementary properties. The water-soluble polymer (e.g., hydroxypropyl methylcellulose) provides rapid dissolution, while the enteric polymer (e.g., methacrylic acid copolymer) provides pH-dependent release, achieving both fast release and high loading capacity.
2Strength
If the thickness of the enteric coating layer is increased to improve impact resistance, then the impact resistance is improved, but the drug release is delayed
Solution Approach 1:
The dual-layer coating structure segments the protective function (outer enteric layer) from the release function (inner water-soluble layer). This allows the outer layer to be optimized for impact resistance while the inner layer ensures rapid drug release, eliminating the trade-off between protection and release speed.
3Quantity of substance
If multiple tablets are used to achieve a large medicinal ingredient dose, then the medicinal ingredient load is improved, but the device complexity and ease of operation are worsened
Solution Approach 1:
The patent merges multiple tablet functions into a single tablet by incorporating a high-capacity dual-layer coating system. This allows one tablet to deliver the equivalent dose of multiple tablets, improving patient compliance and ease of administration.
4Ease of manufacture
If a conventional single-layer enteric coating is used, then the manufacturing process is simple, but the acid resistance and impact resistance are insufficient
Solution Approach 1:
The coating process is segmented into two sequential coating steps, each optimized for a specific function. This modular approach maintains manufacturing simplicity while achieving superior acid and impact resistance through the synergistic combination of two specialized layers.
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
This approach allows for a single tablet to deliver a large medicinal ingredient dose effectively to the lower gastrointestinal tract, enhancing therapeutic efficacy while maintaining high impact resistance and controlled drug release.
Implementation Method 1
a coating layer containing a water-soluble polymer applied onto the surface of the core tablet
Implementation Method 2
an enteric coating layer dissolving at pH 7 or higher which is applied onto the surface of the coating layer containing a water-soluble polymer
Data Source
AI summary
To provide an enteric coated tablet containing a large amount of medicinal ingredient and having sufficient impact resistance, without forming a thick enteric coating layer.The enteric coated tablet contains (A) a core tablet containing a medicinal ingredient and having a weight of 1,000 mg or more; (B) a coating layer containing a water-soluble polymer applied onto the surface of the core tablet; and (C) an enteric coating layer dissolving at pH 7 or higher which is applied onto the surface of the coating layer containing a water-soluble polymer, wherein the sum of the polymer amount of the coating layer (B) and the polymer amount of the coating layer (C) is 10 to 18 mg/cm2, the polymer amount of the coating layer (B) is 6 to 12 mg/cm2, and the polymer amount of the coating layer (C) is 3 to 6 mg/cm2.