US 12,324,838 B2
Intranasal epinephrine formulations and methods for the treatment of disease
Richard Lowenthal, San Diego, CA (US); Edward T. Maggio, San Diego, CA (US); Robert G. Bell, San Diego, CA (US); and Pratik Shah, San Diego, CA (US)
Assigned to AEGIS THERAPEUTICS, LLC, San Diego, CA (US)
Filed by Aegis Therapeutics, LLC, San Diego, CA (US)
Filed on Jun. 1, 2023, as Appl. No. 18/327,621.
Application 18/327,621 is a continuation of application No. 18/049,936, filed on Oct. 26, 2022, granted, now 11,717,571.
Application 18/049,936 is a continuation of application No. 17/396,044, filed on Aug. 6, 2021, granted, now 11,744,895.
Application 17/396,044 is a continuation of application No. 16/869,461, filed on May 7, 2020, granted, now 11,191,838, issued on Dec. 7, 2021.
Application 16/869,461 is a continuation of application No. 16/420,044, filed on May 22, 2019, granted, now 10,682,414, issued on Jun. 16, 2020.
Application 16/420,044 is a continuation of application No. PCT/US2019/016918, filed on Feb. 6, 2019.
Claims priority of provisional application 62/784,057, filed on Dec. 21, 2018.
Prior Publication US 2023/0302137 A1, Sep. 28, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/26 (2006.01); A61K 9/00 (2006.01); A61K 31/485 (2006.01); A61K 31/7016 (2006.01)
CPC A61K 47/26 (2013.01) [A61K 31/485 (2013.01); A61K 31/7016 (2013.01); A61K 9/0043 (2013.01); A61K 9/0048 (2013.01); A61K 9/0056 (2013.01); A61K 9/006 (2013.01)] 11 Claims
 
1. A single-use, pre-primed nasal spray device comprising a single reservoir containing a nasal spray pharmaceutical formulation, wherein,
the nasal spray pharmaceutical formulation has a volume between about 100 μL and about 140 μL and consists of:
between about 1 mg/mL and about 40 mg/mL of epinephrine, or a salt thereof; water;
an alkyl glycoside;
one or more isotonicity agents selected from the group consisting of dextrose, glycerin, mannitol, potassium chloride, and sodium chloride;
optionally ethylenediaminetetraacetic acid (EDTA) or disodium salt thereof, as a stabilizing agent;
optionally benzalkonium chloride as a preservative;
optionally one or more antioxidants selected from the group consisting of alpha tocopherol, D-α-tocopherol polyethylene glycol 1000 succinate, ascorbic acid, isoascorbic acid, butylated hydroxyanisole, citric acid monohydrate, potassium metabisulfite, sodium bisulfite, sodium metabisulfite, and sodium sulfite; and
optionally one or more pH adjustment agents selected from the group consisting of adipic acid, ammonium chloride, citric acid, acetic acid, hydrochloric acid, lactic acid, phosphoric acid, propionic acid, sulfuric acid, tartaric acid, sodium hydroxide, sodium citrate, sodium bicarbonate, sodium carbonate, and combinations thereof, to adjust the pH to a final pH between about 2.0 and about 6.0;
wherein one actuation of the nasal spray device delivers about 100 μL of the nasal spray pharmaceutical formulation into one nostril of a human.