Compositions of food allergens
Inventors
Benhamou, Pierre-Henri • Dupont, Christophe • KOPPELMAN, STEFAN (JOHAN) • Martin, Laurent • BROCHARD, HERVÉ • Foucher, Estelle
Assignees
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Publication Number
US-10881728-B2
Publication Date
2021-01-05
Expiration Date
Abstract
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.
Core Innovation
The invention relates to pharmaceutical particle formulations for oral administration of a food allergen. The particles comprise a neutral core and a first layer comprising the food allergen surrounding the neutral core, and a stomach-labile coating layer stable at neutral pH surrounding the first layer, so the pharmaceutical product releases essentially all the food allergen in the stomach.
The disclosed formulations address food allergen exposure in the mouth and esophagus during oral delivery, including reducing allergen exposure associated with oral residence and limiting unwanted taste and exposure effects. The release profile is controlled by the stomach-labile coating layer stable at neutral pH, so allergen release occurs in the stomach while minimizing release under neutral conditions.
The compositions further enable orally administered formulations for oral immunotherapy and food allergy assessment contexts, including allergy detection and DBPCFC food challenges without taste perception and without delayed absorption effects.
Claims Coverage
The provided content includes one independent claim directed to an orally suitable pharmaceutical particle product for a food allergen with a neutral core, an allergen-containing first layer, and a stomach-labile coating layer stable at neutral pH, with essentially all allergen released in the stomach. Dependent claims refine this with polymer selections, allergen content and homogeneity in the first layer, particle size, and a method to determine subject reactivity.
Neutral core, allergen-containing first layer, and stomach-labile coating stable at neutral pH releasing essentially all allergen in the stomach
A pharmaceutical product suitable for oral administration of a food allergen, where particles comprise a neutral core, a first layer comprising the food allergen surrounding the neutral core, and a stomach-labile coating layer stable at neutral pH surrounding the first layer, and the pharmaceutical product releases essentially all the food allergen in the stomach.
Pharmaceutically-compatible (co-)polymers in the allergen-containing first layer
The first layer comprises the food allergen and one or several pharmaceutically-compatible (co-)polymers selected from a specified group of polymer materials.
Homogeneous first layer covering the entire surface of the core with defined allergen fraction
The first layer contains 70–100% by weight of the total amount of food allergen and is homogeneous, covering the entire surface of the core.
Particle size constraint
The pharmaceutical product has particles with an average size between 1 μm and 10 mm.
Determine subject reactivity using the product
A method determines a subject’s reactivity to a food allergen by administering the product and then determining the subject’s reactivity to the food allergen.
The claim coverage centers on an orally administered particulate product with a neutral core, an allergen-containing first layer, and a stomach-labile coating layer stable at neutral pH, such that essentially all allergen is released in the stomach. Dependent features further specify polymer selections, allergen loading and homogeneity, particle size, and a method for determining subject reactivity.
Stated Advantages
Controlled release so the pharmaceutical product releases essentially all the food allergen in the stomach.
Limiting allergen exposure during oral delivery by using a stomach-labile coating layer stable at neutral pH.
Reducing oral/allergen taste effects by enabling taste-controlled or tasteless formulations for allergy detection/DBPCFC food challenges.
Mitigating risk associated with eosinophilic esophagitis by reducing exposure in the mouth/esophagus.
Documented Applications
Oral immunotherapy (OIT) using the pharmaceutical product for oral administration of a food allergen.
Allergy detection and DBPCFC food challenge use cases where the formulation is used without taste perception and without delayed absorption effects.
Methods for delivering allergens, determining reactivity, and inducing tolerance using the claimed product.
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