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Verfahren zur Herstellung einer Inhalationsatmosphaere fuer die Allergenprovokation

Producing allergen inhalation atmosphere in an exposure room, comprises providing a liquid spray formulation containing solvent, carrier substance and allergen, producing aerosol by spray drying, and distributing the aerosol into room air
 
: Holfeld, J.; Krug, N.; Lödding, H.; Polmann, G.; Windt, H.; Bader, W.; Langer, P.; Stempfle, M.; Dunkhorst, W.; Koch, W.; Schwarz, K.

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DE 102008060614 A: 20081205
DE 102008060614 A: 20081205
A61M0011
B05B0017
B01D0001
A61K0009
A61K0039
German
Patent, Electronic Publication
Fraunhofer ITEM ()

Abstract
(A1) Die vorliegende Erfindung betrifft ein Verfahren zur Herstellung einer Allergeninhalationsatmosphaere in einem Expositionsraum, welches folgende Schritte umfasst: - Bereitstellung einer fluessigen Spruehformulierung, welche ein Loesungsmittel, eine Traegersubstanz und ein Allergen enthaelt, und Herstellung eines Aerosols durch Spruehtrocknung, wobei die Aerosolpartikel die Traegersubstanz und das Allergen enthalten, und - Verteilung des Aerosols in der Raumluft eines Expositionsraumes, wobei der Expositionsraum Vorrichtungselemente zur Erzeugung einer zeitlich und raeumlich konstanten Allergen-Raumluftkonzentration aufweist.

 

DE 102008060614 A1 UPAB: 20100621 NOVELTY - The method comprises providing a liquid spray formulation, which contains a solvent, a carrier substance and an allergen, producing an aerosol by spray drying, where the aerosol particles contain the carrier substance and the allergen, and distributing the aerosol into a room air of an exposure room, where the exposure room has a device element for generation a temporal and spatially constant allergen room air concentration. A freeze-dried allergen extract of a natural allergen-carrier or a recombinantly produced allergen is used for the production of the aerosol by spray drying. DETAILED DESCRIPTION - The method comprises providing a liquid spray formulation, which contains a solvent, a carrier substance and an allergen, producing an aerosol by spray drying, where the aerosol particles contain the carrier substance and the allergen, and distributing the aerosol into a room air of an exposure room, where the exposure room has a device element for generation a temporal and spatially constant allergen room air concentration. A freeze-dried allergen extract of a natural allergen-carrier or a recombinantly produced allergen is used for the production of the aerosol by spray drying. An aqueous spray solution is used for the spray drying. The allergen consists of Der p1 mite allergen, flower pollen allergen, domestic animal allergen and/or house dust allergen. The allergen in the liquid spray formulation is present in a concentration (C(A)) of 0.1-1000 mu g/ml. The carrier substance in the liquid spray formulation is present in a concentration of 0.1-20 wt.%. The atomization of the spray formulation takes place with an atomization device, which is selected from an ultrasonic atomizer, atomizer plate and/or a compressed air spray nozzle. The aerosol particles have a median diameter (d50) of 10-25 mu m. The exposure room has a room volume of 3-300 m3. The simultaneous distribution of the aerosol takes place in the room air by turbulent mixing air flow. The distribution of the aerosol is caused by swirl outlets introduced in an air supply, cover ventilators and/or a floor heater in the exposure room. The distribution of the spray formulation takes place below the cover ventilator and the formed aerosol particles are evenly distributed in the exposure room through the ventilator flow and the turbulent fresh air flow. The atomization device is centrally introduced below the cover ventilator and/or in the immediate proximity to the swirl outlet. The spray formulation is supplied to a dosing device for adjusting a suitable liquid mass flow and subsequently fed back to the atomization device. The air volume flow Q through the exposure room is 600-2000 m3/h. The exposure room is operated with an air change rate of 1000-1600. The distribution of the aerosol leads to allergen concentration in the room air of the exposure room in the range of 0.01-1 mu g/m3. The allergen concentration in the room air of the exposure room is constantly kept with a maximum deviation of 20% over a time period of 1-5 hours. An aerosol monitor and/or laser particle counter are introduced in the exposure room for determining the allergen concentration. An INDEPENDENT CLAIM is included for a device for carrying out an inhalative allergen provocation. USE - Method for producing inhalation atmosphere in an exposure room for inhalative allergen provocation (claimed). ADVANTAGE - The method allows realistic simulation of environmental exposure, site of action in the respiratory tract and bioavailability, high flexibility with respect to the allergen or allergen spectrum to be examined and very good control of allergen spectrum, allergen concentration and particle size, and uses only a technical procedure for the generation and monitoring.

: http://publica.fraunhofer.de/documents/N-139556.html