Allergoid Composition for Intradermal Allergy Treatment
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Solution Overview
Problem
Current allergen extract immunotherapy methods, particularly subcutaneous and sublingual routes, face challenges in safety due to the risk of inducing allergic responses and require tedious dose-finding tests to reach the maximum maintenance dose, often necessitating multiple doses.
Innovation Solution
Development of allergoids through polymerization of allergen extracts with glutaraldehyde, which reduces allergenicity while maintaining immunogenicity, allowing for intradermal administration with a single safe dose that eliminates the need for dose escalation and minimizes volume variability, thereby enhancing safety and efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If subcutaneous or sublingual allergen extract immunotherapy is used, then immunogenicity is achieved, but safety is compromised due to risk of allergic responses and requirement for dose escalation
Solution Approach 1:
The patent applies parameter changes by chemically modifying the allergen extract through polymerization with glutaraldehyde to create allergoids. This chemical transformation reduces the allergenicity while preserving immunogenicity, allowing administration of higher doses without triggering allergic responses. The parameter change in molecular structure (from native allergen to polymerized allergoid) directly resolves the contradiction between achieving immunogenicity and ensuring safety.
Solution Approach 2:
The patent implements preliminary action by pre-determining a fixed safe dose of allergoid (0.1 mL intradermal injection) that has been established to be non-reactive in sensitized patients. This eliminates the need for preliminary dose-escalation protocols and multiple testing phases, as the fixed dose is designed from the outset to be both safe and effective, thereby simplifying the dosing regimen while maintaining reliability.
2Productivity
If dose escalation is performed to reach maximum maintenance dose, then immunogenicity is optimized, but treatment time and complexity increase
Solution Approach 1:
The patent applies preliminary action by pre-establishing the optimal maintenance dose of allergoid (0.1 mL intradermal injection) through prior research and end-point titration studies. This fixed dose is determined in advance to be both safe and immunologically effective, eliminating the need for time-consuming dose-escalation protocols during patient treatment. The preliminary determination of the fixed safe dose directly reduces treatment time while maintaining productivity.
Solution Approach 2:
The patent inverts the conventional approach by starting with a fixed high dose (0.1 mL) rather than beginning with low doses and escalating. The allergoid's reduced allergenicity allows this inverted approach where the maximum effective dose is administered from the outset without requiring gradual escalation, thereby reversing the traditional sequence and significantly reducing the time to reach maintenance dose while maintaining treatment efficiency.
3Reliability
If intradermal administration is used with allergoids, then safety is improved by reducing allergic responses, but dose standardization must be precisely controlled
Solution Approach 1:
The patent applies universality by establishing a single fixed dose (0.1 mL intradermal injection) that serves multiple functions: it is both the diagnostic test dose and the therapeutic maintenance dose. This universal fixed dose eliminates the need for multiple standardized doses at different stages of treatment, simplifying manufacturing precision requirements while maintaining safety through consistent dosing across all treatment phases.
Solution Approach 2:
The patent uses parameter changes in the chemical structure of the allergen (polymerization with glutaraldehyde) to reduce allergenicity by approximately 100-fold compared to native allergens. This parameter change in molecular configuration allows the fixed 0.1 mL dose to be safely administered without requiring extremely precise dose control, as the reduced allergenicity provides a safety margin that accommodates normal dosing variations while maintaining reliability.
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 use of allergoids administered intradermally reduces allergic responses and simplifies the dosing regimen, ensuring safety and efficacy by establishing a non-reactive maximum dose that is safe and effective, reducing the risk of overdose and improving treatment efficiency.
Implementation Method 1
the so-called allergoids obtained by means of polymerizing allergen extracts of, for example, Phleum pratense (Examples 1-5), Parietaria judaica and Artemisia vulgaris (Example 7), Dermatophagoides pteronyssinus (Examples 8 and 9) and Apis mellifera (Examples 10 and 11), with glutaraldehyde
Data Source
AI summary
The present invention relates to a composition for intradermal administration of allergoids which comprises at least one allergoid obtained by means of chemically modifying an allergen extract or an individual allergen, for intradermal administration, useful for the treatment of allergies.