Stabilized non-enveloped virus compositions
AssigneeZiccum AB
InventorsGöran Conradson, Fernando Acevedo Fonseca
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Abstract
The present invention relates to methods and compositions of thermostable nonenveloped virus as obtained by a laminar counter-current spray drying process. The compositions comprise aerosolizable amorphous particles, comprising free, non-encapsulated nonenveloped virus and an excipient, wherein the particles typically have a mass median aerodynamic diameter (MMAD) of less 5 μm and comprise less than 5% water.
Claims21
A thermostable dry composition comprising aerosolizable amorphous particles, comprising free, non-encapsulated noneveloped virus and an excipient, wherein the particles:
- have a mass median aerodynamic diameter (MMAD) of less than 5 μm;
- comprise less than 5% (wt) water;
- and wherein
- the nonenveloped virus of the dry particles maintain its activity following storage at 40° C. for at least seven weeks.
A method of preparing a thermostable aerosolizable dry nonenveloped virus composition by a counter-current spray drying process, the method comprising:
- providing a liquid composition comprising nonenveloped virus and an excipient;
- nebulizing the composition into transportable droplets of less than 50 μm in a tube reactor having an inner region and an outer region;
- admitting the nebulized composition to descend in a laminar carrier gas flow while admitting a laminar flow of dry gas to ascend in the outer region in order to establish a counter-current drying of the descending drops;
- drying the droplets for 30 seconds to 2 minutes at an ambient temperature from 15° C. to 30° C. while admitting vapour to diffuse into the ascending laminar flow, thereby producing a dry composition of particles and
- collecting the dry composition of particles.
(canceled)
Dependencies are inferred from the claim text.