US 11,771,663 B2
Epinephrine spray formulations
Thrimoorthy Potta, Phoenix, AZ (US); Craig Bastian, Gilbert, AZ (US); Ningxin Yan, Chandler, AZ (US); Venkat Goskonda, Phoenix, AZ (US); Chandeshwari Chilampalli, Chandler, AZ (US); Rachana Inavolu, Chandler, AZ (US); and Eshwaran Narayanan, Chandler, AZ (US)
Assigned to Hikma Pharmaceuticals USA Inc., Eatontown, NJ (US)
Filed by HIKMA PHARMACEUTICALS USA INC., Eatontown, NJ (US)
Filed on Mar. 2, 2021, as Appl. No. 17/190,022.
Application 17/190,022 is a continuation of application No. 16/290,853, filed on Mar. 1, 2019, granted, now 10,973,781.
Application 16/290,853 is a continuation in part of application No. 16/240,632, filed on Jan. 4, 2019, granted, now 10,966,925.
Application 16/240,632 is a continuation in part of application No. 16/023,313, filed on Jun. 29, 2018, granted, now 10,617,637, issued on Apr. 14, 2020.
Application 16/023,313 is a continuation in part of application No. 16/007,998, filed on Jun. 13, 2018, granted, now 11,517,525.
Application 16/007,998 is a continuation in part of application No. 16/007,999, filed on Jun. 13, 2018.
Application 16/007,999 is a continuation in part of application No. 15/488,712, filed on Apr. 17, 2017, granted, now 10,039,710, issued on Aug. 7, 2018.
Application 15/488,712 is a continuation in part of application No. 15/264,686, filed on Sep. 14, 2016, abandoned.
Claims priority of provisional application 62/220,320, filed on Sep. 18, 2015.
Prior Publication US 2021/0177777 A1, Jun. 17, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61P 37/08 (2006.01); A61K 47/18 (2017.01); A61K 47/10 (2017.01)
CPC A61K 31/137 (2013.01) [A61K 9/0043 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/186 (2013.01); A61P 37/08 (2018.01)] 16 Claims
OG exemplary drawing
 
1. An epinephrine spray solution consisting of:
from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof;
from 0.9% to 80% w/w water; and
optionally, one or more excipients selected from the group consisting of acids selected from the group consisting of hydrochloric acid, malic acid, tartaric acid, citric acid, succinic acid and combinations thereof, stabilizers selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, ascorbic acid, methionine, sodium ascorbate, sodium thiosulfate, sodium bisulfite, sodium metabisulfite, ascorbyl palmitate, thioglycerol, alpha tocopherol, cysteine hydrochloride, benzalkonium chloride, citric acid, ethylenediaminetetraacetic acid, sodium citrate, propyl gallate, 8-hydroxyquinoline, boric acid, histidine and combinations thereof, solvents, antioxidants, preservatives, permeation enhancers, viscosity modifiers, sweeteners, sweetness enhancers, pH modifiers, isotonicity agents and flavoring agents, wherein w/w denotes weight by weight of the solution and wherein the solution has a pH from about 2 to about 7.