Gastro-Resistant Capsule Shell for Protease Delivery
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Solution Overview
Problem
Current oral administration of proteolytic enzymes requires multiple daily doses due to the need for enterically coated tablets, which can be cumbersome for patients to adhere to.
Innovation Solution
Development of gastro-resistant capsules with a shell comprising a water-soluble film forming polymer like HPMC and a water-soluble enteric polymer like pectin, which releases proteolytic enzymes in the upper small intestine, mimicking the kinetic profile of enterically coated tablets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If enterically coated tablets are used to deliver proteolytic enzymes, then the enzymes are released at the correct location in the gastrointestinal tract, but the dosage frequency must be six tablets or more daily which reduces patient compliance
Solution Approach 1:
The patent combines multiple enterically coated tablets into a single gastro-resistant capsule containing multiple proteolytic enzymes (bromelain, papain, ficin, trypsin, chymotrypsin). This merging of multiple dosage units into one administered unit maintains the reliability of targeted enzyme release in the small intestine while dramatically improving ease of operation by reducing the burden of taking six or more tablets daily to just one capsule
Solution Approach 2:
The capsule shell uses a composite material system combining water-soluble film-forming polymers (HPMC, gelatin) with water-soluble enteric polymers (pectin, propylene glycol alginate). This composite polymer system provides both gastro-resistance and controlled release properties, enabling the capsule to protect enzymes through the stomach and release them at the appropriate location in the small intestine, thereby maintaining reliability while improving patient compliance
2Strength
If a capsule shell with water-soluble film forming polymer and gellan gum is used, then the capsule structure is formed, but the proteolytic enzymes are not released at the right point in the gastrointestinal tract
Solution Approach 1:
The patent changes the chemical composition parameter of the capsule shell by replacing gellan gum with water-soluble enteric polymers such as pectin and propylene glycol alginate. This parameter change transforms the shell's properties from simple structural support to a system that provides both structural integrity and pH-responsive release behavior, enabling reliable enzyme release at the correct gastrointestinal location while maintaining adequate shell strength
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 gastro-resistant capsule formulation allows for fewer administrations while maintaining effective enzyme release, improving patient compliance and therapeutic efficacy.
Implementation Method 1
The capsule shell may be insoluble under gastric conditions and soluble under small intestinal conditions. Suitably, gastric conditions are about pH 2.0 at about 37° C. and/or small intestinal conditions are from about pH 5.5 to about pH 7.0 at about 37° C.
Implementation Method 2
The pectin has a degree of esterification of from about 15% to about 40%, from about 20% to about 35%, or from about 20% to about 30%. Suitably, the pectin has a degree of amidation of from about 0% to about 25%, from about 10% to about 25%, or from about 15% to about 25%.
Data Source
AI summary
The present invention relates to a gastro resistant capsule comprising one or more proteases. wherein the capsule shell comprises a water-soluble film forming polymer and a water-soluble enteric polymer. The present invention also relates to methods of manufacturing the gastro resistant capsules and uses thereof.