Enteric Coated Solid Dosage Forms for Bacteria and mEVs
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Solution Overview
Problem
Existing solid dosage forms containing bacteria and/or microbial extracellular vesicles (mEVs) for oral administration face challenges in maintaining gastric integrity and achieving controlled release in the intestinal tract, affecting therapeutic efficacy.
Innovation Solution
Development of enteric-coated solid dosage forms with specific coating levels to protect bacteria and/or mEVs from stomach release, allowing controlled release in the small intestine, such as in the jejunum or ileum, by varying the enteric coating thickness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an enteric coating is applied to protect bacteria and/or mEVs from stomach release, then gastric integrity is maintained, but the time and site of release in the intestine is not precisely controlled
Solution Approach 1:
The patent applies parameter changes by varying the enteric coating level (thickness) to precisely control the release site and time. Different coating levels (e.g., 1 mg/cm² to 6 mg/cm²) are used to achieve specific release characteristics in different intestinal segments, thereby resolving the contradiction between maintaining gastric integrity and controlling release precision.
Solution Approach 2:
The patent implements local quality by designing the enteric coating to have different functional characteristics at different locations along the gastrointestinal tract. The coating level is optimized to ensure protection in the stomach while enabling controlled release at specific intestinal locations (jejunum, ileum, or colon), achieving both gastric integrity and precise release control.
2Duration of action of moving object
If the enteric coating level is increased to extend release time, then the site of release moves downstream, but therapeutic efficacy may be reduced due to premature protection or delayed release
Solution Approach 1:
The patent uses parameter changes to optimize the coating level for maximum therapeutic efficacy. By establishing specific coating level ranges (1-6 mg/cm²), the patent ensures that the release time is extended sufficiently to protect against gastric acid while maintaining timely release in the intestine to achieve the desired therapeutic effect.
Solution Approach 2:
The patent incorporates feedback mechanisms through in vitro dissolution studies and scintigraphy studies to evaluate and optimize the release characteristics. This feedback allows for adjustment of the coating level to ensure both extended protection and timely release, maximizing therapeutic efficacy.
3Object-affected harmful factors
If a thicker enteric coating is used to ensure gastric protection, then bacteria and/or mEVs are better protected from stomach acid, but the release control precision in the intestine is reduced
Solution Approach 1:
The patent applies parameter changes by establishing an optimized coating level range (1-6 mg/cm²) that provides sufficient protection against stomach acid while maintaining precise control over release site. This specific parameter range resolves the contradiction by ensuring both adequate protection and controllability.
Solution Approach 2:
The patent implements local quality by optimizing the coating to provide differential protection and release characteristics. The coating level is designed to ensure adequate protection in the stomach while enabling precise release control at specific intestinal locations, achieving both harm prevention and precise delivery.
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 enteric coating level significantly influences the time and site of release in the intestine, enhancing therapeutic efficacy and allowing for targeted delivery of pharmaceutical agents to specific intestinal locations.
Implementation Method 1
the enteric coating maintains gastric integrity
Implementation Method 2
the coating level of the enteric coat influences the time to release (e.g., the start of release) of the pharmaceutical agent from the solid dosage form
Data Source
AI summary
Enterically-coated solid dosage forms containing a pharmaceutical agent which includes bacteria and/or microbial extracellular vesicles (mEVs) are provided. Methods of treatment using such solid dosage forms are also provided.