Pre-functionalized Hard Shell Capsule with pH-5 Targeted Release
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Solution Overview
Problem
Existing coating systems for pre-coated capsules are not suitable for targeted release in the duodenum, as they do not provide the necessary intermediate and enteric coating layers for effective drug delivery at pH 5.
Innovation Solution
A process for preparing polymer-coated hard shell capsules with an intermediate coating layer containing an anionic polymer and an enteric coating layer with a polymer having a low glass transition temperature, specifically designed for targeted release in the duodenum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing coating systems are used for pre-coated capsules, then general capsule coating is achieved, but targeted release in the duodenum at pH 5 is not achieved
Solution Approach 1:
The coating system is divided into two distinct layers: an intermediate coating layer applied first, followed by an enteric coating layer. This segmentation allows each layer to perform its specific function - the intermediate layer provides adhesion and surface preparation, while the enteric layer enables pH-dependent release at pH 5 in the duodenum.
Solution Approach 2:
Different regions of the capsule coating have different properties. The intermediate coating layer has specific compositional characteristics (containing basic agents like magnesium oxide or calcium carbonate) that differ from the enteric coating layer, allowing localized functionality for both adhesion and pH-triggered release.
2Reliability
If a single coating layer is applied, then manufacturing process is simple, but dual functionality (adhesion and pH-triggered release) is not achieved
Solution Approach 1:
The coating is segmented into functional layers with the intermediate layer providing adhesion and the enteric layer providing pH-triggered release. This segmentation enables dual functionality while maintaining a relatively simple two-step coating process.
Solution Approach 2:
The coating system uses composite material composition where the intermediate layer contains basic agents (magnesium oxide, calcium carbonate) and the enteric layer contains enteric polymers. This composite structure enables both adhesion and pH-dependent release within a unified coating system.
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 polymer-coated hard shell capsules achieve less than 10% drug release at 0.1N HCl for 120 minutes, followed by at least 80% drug release at pH 5 within an additional 150 minutes, ensuring targeted delivery in the duodenum.
Implementation Method 1
wherein the first polymer is an anionic polymer having a Tgm≥35° C.; wherein the second polymer is a polymer having a Tgm of ≤30° C.
Data Source
AI summary
A process prepares a polymer-coated hard shell capsule including an intermediate coating layer, an enteric coating layer, and optionally a top coating layer, suitable as a container for pharmaceutical or nutraceutical biologically active ingredients. The hard shell capsule includes a body and a cap, and in a closed state, the cap overlaps the body either in a pre-locked state or in a final-locked state. The hard shell capsule is provided in the pre-locked state and is coated with a first coating solution, suspension or dispersion to obtain the intermediate coating layer of the hard shell capsule in the pre-locked state. Thereafter, the hard shell capsule is coated with a second coating solution, suspension or dispersion, which is different from the first coating solution, suspension or dispersion, to obtain the enteric coating layer of the hard shell capsule in the pre-locked state.