Gastric-Residence Capsules With Reverse-Enteric Coating
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Solution Overview
Problem
Existing gastric residence systems face challenges in controlling their unfolding within the gastrointestinal tract, potentially leading to premature deployment in the esophagus, delayed deployment in the intestine, or failure to unfold at all, thereby compromising the delivery of therapeutic agents to the stomach.
Innovation Solution
The use of capsules and capsule coatings, including a sleeve or band to maintain a folded configuration and a reverse-enteric coating to ensure dissolution in the stomach, controlling the unfolding time and location of gastric residence systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a gastric residence system is administered in a folded configuration, then it can be swallowed and reach the stomach, but it risks unfolding too early in the esophagus causing obstruction
Solution Approach 1:
The capsule is designed with a dissolution coating that prevents premature unfolding by maintaining the folded configuration during esophageal passage. The coating dissolves only under specific gastric conditions (pH, enzymes), ensuring the gastric residence system unfolds at the intended location and time, thereby preventing esophageal obstruction while maintaining swallowability.
2Speed
If the capsule dissolves quickly, then the gastric residence system can deploy faster, but it may unfold too early before reaching the stomach
Solution Approach 1:
The capsule employs a dissolution coating with spatially varying properties - the coating is designed to remain intact in the esophagus (neutral pH) and only dissolve in the specific local environment of the stomach (acidic pH with digestive enzymes). This local quality differentiation ensures rapid deployment occurs at the correct location while preventing premature unfolding during transit.
3Reliability
If the capsule is coated with a protective coating, then it prevents premature dissolution, but it may delay dissolution too long causing the system to pass through the stomach
Solution Approach 1:
The dissolution coating is formulated with specific pH-sensitive parameters that trigger dissolution within a precise time window. The coating withstands esophageal conditions but dissolves rapidly when exposed to gastric pH and enzymatic conditions, ensuring the gastric residence system deploys within the stomach residence time while preventing both premature and delayed dissolution.
4Length of moving object
If the gastric residence system remains folded, then it can pass through the pyloric valve, but it fails to deliver the therapeutic agent to the stomach
Solution Approach 1:
The capsule design incorporates a dynamic transformation mechanism: the gastric residence system transitions from a folded configuration (small size for capsule containment and pyloric passage) to an unfolded configuration (large size for gastric residence and therapeutic delivery). The dissolution of the capsule coating triggers this dynamic change, ensuring the system unfolds at the optimal moment to deliver the therapeutic agent while maintaining the ability to pass through the pyloric valve.
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
Ensures that gastric residence systems unfold and deploy at the desired time and location within the stomach, minimizing the risk of esophageal or intestinal obstructions and ensuring effective delivery of therapeutic agents.
Implementation Method 1
Some gastric residence dosage forms may include a reverse-enteric coating to ensure dissolution of the capsule in a gastric environment, and not prior to the gastric environment
Data Source
AI summary
Provided are gastric residence dosage forms comprising: a gastric residence system in a folded configuration; a capsule encapsulating the gastric residence system in a folded configuration; and a coating on the capsule, wherein the gastric residence dosage form is configured to release the gastric residence system in a stomach of a patient, allowing the gastric residence system to assume an open configuration. The coating on the capsule includes a polymer, an anti-tacking agent, and/or a hydration aid.