US 11,813,231 B2
Nasal formulations of metoclopramide
Matthew J. D'Onofrio, San Diego, CA (US); David A. Gonyer, Cardiff, CA (US); Shirish A. Shah, Phoenix, AZ (US); and Stuart J. Madden, Ellicott City, MD (US)
Assigned to Evoke Pharma, Inc., Solana Beach, CA (US)
Filed by Evoke Pharma, Inc., Solana Beach, CA (US)
Filed on Jul. 2, 2021, as Appl. No. 17/366,829.
Application 17/366,829 is a continuation of application No. 17/100,664, filed on Nov. 20, 2020, granted, now 11,628,150.
Application 17/100,664 is a continuation of application No. 16/181,841, filed on Nov. 6, 2018, granted, now 11,020,361, issued on Jun. 1, 2021.
Application 16/181,841 is a continuation of application No. 15/130,086, filed on Apr. 15, 2016, abandoned.
Application 15/130,086 is a continuation of application No. 13/660,709, filed on Oct. 25, 2012, abandoned.
Application 13/660,709 is a continuation of application No. 12/645,108, filed on Dec. 22, 2009, granted, now 8,334,281, issued on Dec. 18, 2012.
Claims priority of provisional application 61/140,034, filed on Dec. 22, 2008.
Prior Publication US 2021/0338608 A1, Nov. 4, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/166 (2006.01); C07C 237/44 (2006.01); A61M 11/02 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61M 15/08 (2006.01)
CPC A61K 31/166 (2013.01) [A61K 9/0043 (2013.01); A61K 9/08 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61M 11/02 (2013.01); C07C 237/44 (2013.01); A61M 15/08 (2013.01)] 20 Claims
 
1. An intranasal pharmaceutical composition having a pH of above about 4.5, comprising metoclopramide, or a pharmaceutically acceptable salt thereof, and either (1) benzalkonium chloride at a concentration of at least 0.025% (w/v) and up to about 0.05% (w/v) or (2) benzyl alcohol at a concentration of less than 1% (w/v); wherein the intranasal pharmaceutical composition exhibits less than about 2% average change in percent optical density (O.D.) per week per 200 mg/mL of metoclopramide when stored at a temperature of 40° C. and 75% relative humidity for at least about 4 weeks.