	US 12,233,049 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 SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by Slayback Pharma LLC, Princeton, NJ (US)
Filed on Jul. 15, 2022, as Appl. No. 17/866,115.
Claims priority of application No. 202141052364 (IN), filed on Nov. 15, 2021.
Prior Publication US 2023/0149359 A1, May 18, 2023
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)]

23 Claims

1. A liquid pharmaceutical composition having extended stability, said composition consisting of:

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

(b) sodium chloride as a stabilizer at a concentration of about 2.5 mg/mL;

(d) a sweetener at a concentration of about 0.20 mg/mL;

(e) a flavoring agent at a concentration of about 0.20 mg/mL; and

(f) water; and

(g) optionally, a pH adjusting agent;

wherein said composition is free of buffer;

wherein said composition is contained in a multi-dose container;

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 6 months at 25° C./40% RH or 25° C./60% RH or 40° C./25% RH or 40° C./75% RH.