Segmented Allergen Pellets for Controlled Stomach Delivery
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Solution Overview
Problem
Current methods for food allergy diagnosis and treatment, such as double-blinded, placebo-controlled food challenges, face challenges in standardizing food formulations, leading to false-positive reactions and delayed absorption due to the use of opaque capsules that are difficult to administer and may cause adverse reactions.
Innovation Solution
Development of novel formulations that deliver food allergens to the stomach, allowing controlled exposure and rapid absorption, avoiding the oral cavity and esophagus, and incorporating a stomach-labile coating for quick dissolution and taste masking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If opaque capsules are used to mask food flavor, then false-positive reactions are reduced, but absorption is delayed and administration becomes difficult
Solution Approach 1:
The food challenge material is divided into multiple small pellets instead of using a single large capsule. Each pellet contains the food allergen mixed with masking agents, and the pellets are designed to dissolve rapidly in the gastrointestinal tract. This segmentation allows the material to be easily administered while ensuring rapid absorption and avoiding the problems associated with large capsules.
Solution Approach 2:
The invention changes the physical parameters of the food challenge material by formulating it as small, rapidly dissolving pellets with specific size and dissolution characteristics. This allows the material to transition from a form that is difficult to administer (large capsules) to a form that is easily administered but still provides adequate masking and rapid absorption.
2Quantity of substance
If large quantities of food allergen are used in capsules, then adequate exposure is achieved, but step-by-step release causes dangerous reactions
Solution Approach 1:
The total allergen dose is divided into multiple small pellets, each containing a portion of the total allergen. This segmentation allows for controlled, gradual release of the allergen as the pellets dissolve sequentially in the gastrointestinal tract, preventing the sudden release of large amounts of allergen that could cause dangerous reactions.
Solution Approach 2:
The dissolution and release of allergen occurs in a periodic, step-by-step manner as each pellet dissolves independently. This periodic release pattern allows for controlled exposure to the allergen over time, preventing sudden large-dose exposure while still achieving the required total dosage for effective food challenge.
3Object-generated harmful factors
If processed food is used in capsules, then flavor masking is improved, but allergen integrity is destroyed
Solution Approach 1:
The invention changes the processing parameters by using mild processing conditions that preserve allergen integrity while still achieving adequate flavor masking. The food allergen is mixed with masking agents in a way that does not require harsh processing that would denature the allergen proteins, thus maintaining both masking effectiveness and allergen activity.
4Quantity of substance
If multiple capsules are administered, then adequate allergen dose is achieved, but patient compliance decreases
Solution Approach 1:
Multiple small pellets that would otherwise need to be administered as separate capsules are combined into a single administered unit. The pellets are designed to be given together as one dose, eliminating the need for patients to swallow multiple separate capsules while still delivering the required total allergen dose through the combined effect of all pellets.
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
These formulations enable precise and controlled exposure of food allergens to the gut immune system, reducing false-positive reactions and adverse effects, allowing for effective tolerance induction and improved diagnostic accuracy.
Implementation Method 1
the product dissolves in the stomach
Data Source
AI summary
The invention relates to novel compositions and methods for diagnosing or treating food allergies. The invention particularly discloses new approaches for delivering food allergens to allergic patients by oral administration of formulations which dissolve and release proteins in the stomach. The invention allows the treatment of food allergies by delivering food allergens to the gut immune system with controlled exposure of the esophagus or oral cavity. The invention also allows to perform food challenges to assess the threshold of clinical reactivity without exposing the esophagus and oral cavity. The invention may be used in any subject, particularly human subjects, and is applicable to any food allergen.