Mite Allergen Extract Fractionation for Consistent Dosage
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Solution Overview
Problem
Current pharmaceutical products for house dust mite allergy and allergic asthma face challenges in maintaining consistent and controlled levels of group 1 and group 2 allergens, leading to batch-to-batch variation and inadequate treatment of patients sensitized to these allergens.
Innovation Solution
The development of pharmaceutical products comprising extracts of Der p and Der f mite bodies and faecal particles, with purification methods to achieve high purity fractions (>70% v/v) and controlled weight ratios of group 1 to group 2 allergens, allowing for precise formulation and improved consistency across batches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional allergen extracts are prepared from whole mite cultures, then the extraction process is simple, but the allergen content shows batch-to-batch variation and lacks consistency
Solution Approach 1:
The patent divides the mite culture into separate fractions based on size and composition. A first fraction containing mite bodies is separated from a second fraction containing faecal particles through filtration or centrifugation. This segmentation allows each fraction to be processed independently to achieve consistent allergen content, resolving the batch-to-batch variation problem while maintaining manufacturing feasibility.
Solution Approach 2:
The patent controls the ratio of group 1 to group 2 allergens by adjusting the proportions of mite body extract and faecal particle extract in the final formulation. By changing the composition parameters of the combined extract, consistent allergen content can be achieved across batches, addressing the manufacturing precision issue.
2Ease of manufacture
If allergen extracts contain natural ratios of group 1 and group 2 allergens from whole mite cultures, then the extraction process is straightforward, but patients sensitized to specific allergens receive inadequate treatment
Solution Approach 1:
The patent allows modification of the allergen composition parameters by combining mite body extract and faecal particle extract in controlled ratios. This enables the final product to contain adjusted proportions of group 1 and group 2 allergens, ensuring effective treatment for patients sensitized to specific allergens while maintaining a straightforward extraction process for each fraction.
3Manufacturing precision
If high purity mite body fractions are isolated through purification steps, then the allergen content becomes more controlled, but the manufacturing process becomes more complex
Solution Approach 1:
The patent uses simple filtration or centrifugation to separate mite bodies from faecal particles based on their physical differences. This segmentation achieves controlled allergen content through straightforward physical separation methods, minimizing process complexity while maintaining manufacturing precision.
4Manufacturing precision
If separate extracts of mite bodies and faecal particles are combined in controlled ratios, then consistent allergen content is achieved, but the formulation process becomes more complex
Solution Approach 1:
The patent controls the formulation by adjusting the ratio of mite body extract to faecal particle extract to achieve desired allergen content. This parameter-based formulation approach ensures consistent allergen content across batches while using a systematic but not overly complex combination process.
Data Source
Figure 1
AI summary
The inventon relates to a pharmaceutical product comprising an allergen extract or an allergoid thereof for the treatment and/or prevention of allergy and allergic asthma caused by house dust mites, which extract comprises at least one extract of mite bodies selected from the following groups a)-b): a) An extract of Der p mite bodies, and b) An extract of Der f mite bodies, and at least one extract of mite cultures selected from the following groups c)-g): c) An extract of Der p faecal particles, d) An extract of Der f faecal particles, e) An extract of Der f whole mite culture, f) An extract of an Der p whole mite culture, and g) a combination of extracts c) to f).