Single-Layer Enteric Coating for Stable Omeprazole Tablets
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Solution Overview
Problem
Existing benzimidazole formulations for oral administration, such as Omeprazole, are susceptible to degradation in acidic environments, and previous solutions involving intermediate layers complicate manufacturing, increase costs, and leave residual volatile excipients.
Innovation Solution
A benzimidazole formulation with a single enteric coating layer, neutralized by alkalizing agents, is applied directly to the substrate without an intermediate layer, maintaining stability and reducing residual volatile excipients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If an intermediate layer is added between the alkaline core and enteric coating to prevent degradation, then the stability of the benzimidazole is improved, but the device complexity and manufacturing cost increase
Solution Approach 1:
The patent removes the intermediate layer from the coating structure, extracting only the essential enteric coating layer while maintaining stability through optimized formulation and direct coating methodology
Solution Approach 2:
The patent combines the protective functions into a single integrated enteric coating layer that directly contacts the alkaline core, merging multiple coating layers into one while maintaining stability through careful selection of enteric coating materials and neutralizing agents
2Reliability
If an intermediate layer is used to protect the enteric coating from reacting with the alkaline core, then the reliability of the enteric coating is improved, but the manufacturing precision and time are worsened
Solution Approach 1:
The patent uses a buffering agent as an intermediary substance within the enteric coating layer that neutralizes the alkaline core's effect, preventing direct reaction between the core and enteric coating while maintaining a simple single-layer structure
Solution Approach 2:
The patent modifies the pH parameters of the enteric coating formulation to create a stable interface with the alkaline core, adjusting the buffering capacity and pH gradient to prevent degradation reactions
3Stability of the object's composition
If traditional multi-layer coating is used to protect benzimidazole, then the stability during storage is improved, but the loss of volatile excipients increases
Solution Approach 1:
The patent eliminates unnecessary intermediate layers that contribute to volatile excipient content, retaining only the essential enteric coating layer with minimized volatile components
Data Source
AI summary
An omeprazole delayed release tablet comprises a core and an enteric coating over the core. The core consists essentially of omeprazole, lactose, sodium starch glycolate, sodium stearate, and sodium stearyl fumarate. The enteric coating over the core consists essentially of hydroxypropyl methyl cellulose (HPMC) acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, monoethanol amine, and less than 500 ppm of residual ammonium hydroxide.