US 12,440,566 B2
Compositions and kits for omeprazole suspension
Zeus Pendon, Woburn, MA (US); and Steven Dinh, Burlington, MA (US)
Assigned to AZURITY PHARMACEUTICALS, INC., Woburn, MA (US)
Filed by Azurity Pharmaceuticals, Inc., Woburn, MA (US)
Filed on Mar. 30, 2023, as Appl. No. 18/128,550.
Application 18/128,550 is a continuation of application No. 18/128,451, filed on Mar. 30, 2023, granted, now 12,042,539.
Application 18/128,451 is a continuation of application No. 18/128,344, filed on Mar. 30, 2023, granted, now 11,911,473.
Application 18/128,344 is a continuation of application No. 17/576,496, filed on Jan. 14, 2022, granted, now 11,633,478.
Application 17/576,496 is a continuation of application No. PCT/US2020/042157, filed on Jul. 15, 2020.
Application PCT/US2020/042157 is a continuation in part of application No. 16/513,604, filed on Jul. 16, 2019, granted, now 10,751,333, issued on Aug. 25, 2020.
Prior Publication US 2023/0270862 A1, Aug. 31, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/10 (2017.01); A61K 9/10 (2006.01); A61K 31/4439 (2006.01); A61K 47/02 (2006.01); A61K 47/14 (2017.01); A61K 47/24 (2006.01); A61K 47/38 (2006.01)
CPC A61K 47/10 (2013.01) [A61K 9/10 (2013.01); A61K 31/4439 (2013.01); A61K 47/02 (2013.01); A61K 47/14 (2013.01); A61K 47/24 (2013.01); A61K 47/38 (2013.01)] 20 Claims
 
1. A freeze-thaw stable liquid diluent for reconstituting a proton pump inhibitor, comprising:
a poloxamer,
a suspending agent, wherein the suspending agent is sodium carboxymethyl cellulose (CMC), microcrystalline cellulose, or any combination thereof;
sodium bicarbonate,
simethicone emulsion,
a preservative,
water, and
optionally one or more excipients selected from a flavoring agent, a sweetener, and coloring agent,
wherein the freeze-thaw stable liquid diluent does not comprise glycerin or xanthan gum; and
wherein the freeze-thaw stable liquid diluent is stable for at least 30 days at 5±3° C. and is resistant to gel formation for at least one freeze-thaw cycle.