US 12,303,472 B2
Pharmaceutical device for use in intranasal administration
Jonas Sävmarker, Uppsala (SE); and Robert Rönn, Uppsala (SE)
Assigned to OREXO AB, Uppsala (SE)
Filed by OREXO AB, Uppsala (SE)
Filed on May 24, 2023, as Appl. No. 18/323,115.
Application 18/323,115 is a continuation of application No. PCT/GB2022/052983, filed on Nov. 25, 2022.
Claims priority of application No. 2117016 (GB), filed on Nov. 25, 2021.
Prior Publication US 2023/0310349 A1, Oct. 5, 2023
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 47/26 (2006.01); A61K 47/36 (2006.01)
CPC A61K 31/137 (2013.01) [A61K 9/0043 (2013.01); A61K 9/0075 (2013.01); A61K 47/26 (2013.01); A61K 47/36 (2013.01)] 30 Claims
 
1. A method of treatment of an allergic reaction, which method comprises:
administering a powder composition from a needle-free intranasal applicator to a patient suffering from, or susceptible to, said allergic reaction, which applicator is suitable for administering said powder composition into a nostril of a human patient, wherein the applicator comprises:
(i) an opaque reservoir comprising said powder composition; and
(ii) an outlet through which, following actuation, said powder composition may be dispensed,
wherein said powder composition comprises a pharmacologically-effective dosage amount of epinephrine (adrenaline), or a pharmaceutically-acceptable salt thereof, as the sole active ingredient, and wherein said powder composition comprises a composite material in powder form, which composite material includes the epinephrine or salt thereof and a pharmaceutically-acceptable carrier material, wherein the epinephrine or salt thereof and the pharmaceutically-acceptable carrier material are presented together within single amorphous particles; and
which powder composition is essentially free of water and wherein the epinephrine or salt thereof is less than about 4% chemically degraded after storage of the powder composition for:
(a) at least about 3 months at 40° C. and 75% relative humidity; and/or
(b) at least about 18 months at below about 30° C.; and/or
(c) at least about 18 hours at above about 1 million lux of UV light.