US 12,409,211 B2
Non-protein Clostridial toxin compositions
Maurice Abiad, Anaheim, CA (US); Bhas Dani, San Diego, CA (US); and Evgenyi Shalaev, Dana Point, CA (US)
Assigned to Allergan, Inc., Irvine, CA (US)
Filed by Allergan, Inc., Irvine, CA (US)
Filed on Apr. 8, 2024, as Appl. No. 18/629,715.
Application 18/629,715 is a division of application No. 18/136,048, filed on Apr. 18, 2023, granted, now 12,144,847.
Application 18/136,048 is a division of application No. 17/185,312, filed on Feb. 25, 2021, abandoned.
Application 16/531,800 is a division of application No. 15/703,527, filed on Sep. 13, 2017, granted, now 10,369,190, issued on Aug. 6, 2019.
Application 17/185,312 is a continuation of application No. 16/531,800, filed on Aug. 5, 2019, granted, now 10,973,890, issued on Apr. 13, 2021.
Claims priority of provisional application 62/394,009, filed on Sep. 13, 2016.
Prior Publication US 2024/0252604 A1, Aug. 1, 2024
Int. Cl. A61K 38/48 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 38/16 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61P 9/06 (2006.01); A61P 13/00 (2006.01); A61P 21/00 (2006.01); A61P 25/24 (2006.01); A61P 29/00 (2006.01)
CPC A61K 38/4893 (2013.01) [A61K 9/0019 (2013.01); A61K 9/19 (2013.01); A61K 38/164 (2013.01); A61K 38/48 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61P 9/06 (2018.01); A61P 13/00 (2018.01); A61P 21/00 (2018.01); A61P 25/24 (2018.01); A61P 29/00 (2018.01)] 21 Claims
 
1. A method of making a stable solid pharmaceutical composition which is free of animal protein excipients, the method comprising:
compounding a Clostridial botulinum toxin active ingredient with two or more non-protein excipients to form a compounded mixture;
wherein the two or more non-protein excipients comprise:
(i) a poloxamer surfactant; and
(ii) about 0.01 to 5 wt % methionine; and
lyophilizing or vacuum drying the compounded mixture to produce the solid pharmaceutical composition;
wherein the composition is suitable for subcutaneous or intramuscular injection after reconstitution with an aqueous carrier.