	US 12,329,752 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 Aug. 31, 2021, as Appl. No. 17/463,258.
Application 17/463,258 is a division of application No. 17/017,295, filed on Sep. 10, 2020, granted, now 11,103,492.
Application 17/017,295 is a continuation of application No. 16/998,731, filed on Aug. 20, 2020, granted, now 11,771,686.
Application 16/998,731 is a continuation of application No. 16/513,604, filed on Jul. 16, 2019, granted, now 10,751,333, issued on Aug. 25, 2020.
Prior Publication US 2022/0031683 A1, Feb. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4439 (2006.01); A61K 9/00 (2006.01); A61K 31/351 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/24 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 47/38 (2006.01); A61P 1/04 (2006.01); C07D 401/12 (2006.01)

CPC A61K 31/4439 (2013.01) [A61K 9/0053 (2013.01); A61K 31/351 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/24 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61K 47/38 (2013.01); A61P 1/04 (2018.01); C07D 401/12 (2013.01)]

17 Claims

1. An oral liquid suspension of a proton pump inhibitor consisting essentially of:

a proton pump inhibitor;

1.0%-4.0% w/v of a poloxamer;

a suspending agent, wherein the suspending agent is (i) sodium carboxymethylcellulose (CMC) or (ii) a combination of sodium CMC and microcrystalline cellulose, and wherein the suspending agent is present in the suspension in an amount of about 0.5% to 5% w/v;

8.0%-8.8% w/v of an acid neutralizing agent;

0.1%-0.3% w/v of a defoamer;

0.2%-1.2% w/v of a preservative:

water;

optionally a buffer that maintains a pH of 8 to 9.5; and

optionally one or more selected from, a sweetener, a coloring agent, and a flavoring agent;

wherein the oral liquid suspension is homogenous and stable for at least 30 days at ambient conditions and at refrigerated temperature conditions, and wherein the suspension is formulated to be orally administered to a human subject in need thereof.