	US 12,440,474 B2
	Stable pharmaceutical compositions of clonidine
Shailendra Mandge, Hyderabad (IN); Harish Gunda, Nizamabad (IN); Naga Venkata Durga Prasad Ketha, Hyderabad (IN); Venkateshwar Reddy Keesara, Hyderabad (IN); Satheesh Balasubramanian, Hyderabad (IN); and Sumitra Ashokkumar Pillai, Hyderabad (IN)
Assigned to AZURITY PHARMACEUTICALS, INC., Woburn, MA (US)
Filed by SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed on Jan. 15, 2025, as Appl. No. 19/021,882.
Application 19/021,882 is a continuation of application No. 17/866,115, filed on Jul. 15, 2022, granted, now 12,233,049.
Claims priority of application No. 202141052364 (IN), filed on Nov. 15, 2021.
Prior Publication US 2025/0152558 A1, May 15, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4168 (2006.01); A61J 1/06 (2006.01); A61J 1/14 (2023.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01)

CPC A61K 31/4168 (2013.01) [A61J 1/065 (2013.01); A61J 1/1468 (2015.05); A61K 9/0053 (2013.01); A61K 47/02 (2013.01)]

19 Claims

1. A liquid pharmaceutical composition consisting of:

(a) clonidine hydrochloride at a concentration of about 20 μg/mL;

(b) stabilizer at a concentration of about 0.001% to 20% w/w, based on total weight of the composition;

(d) a sweetener;

(e) a flavoring agent; and

(f) water; and

(g) optionally, a pH adjusting agent;

wherein said composition is free of buffer;

wherein said composition is an oral solution; and

wherein not more than 2% w/w of total impurities are formed when said composition is stored for at least 3 months at 25° C./40% RH or 25° C./60% RH.