Claims for Patent: 10,993,952

Summary for Patent: 10,993,952

Title:	Stable ready to use cyclophosphamide liquid formulations
Abstract:	The present invention relates to stable ready to use liquid formulations of Cyclophosphamide for parenteral use. The ready to use composition comprises Cyclophosphamide dissolved in a solvent system comprising a solvent, cosolvent(s) and antioxidant(s).
Inventor(s):	Chandrashekhar; Kocherlakota (Secunderabad, IN), Nagaraju; Banda (Hyderabad, IN)
Assignee:	LEIUTIS PHARMACEUTICALS PVT. LTD. (Hyderabad, IN)
Application Number:	15/551,507
Patent Claims:	1. A stable liquid parenteral formulation of cyclophosphamide comprising i) cyclophosphamide in a concentration of about 12% to about 23% based on total formulation weight; ii) an ethanol content of about 70% to about 75% based on total formulation weight; iii) both polyethylene glycol and propylene glycol, wherein a polyethylene glycol to propylene glycol mass ratio is between approximately 1.0:1.0 to approximately 2.0:1.0; and iv) about 3.4% to about 8.8% based on total formulation weight of polyethylene glycol v) about 3.4% to about 4.4% based on total formulation weight of propylene glycol vi) wherein, after storage for 7 days at 40.degree. C./75% RH, decomposition to form any of the following impurities is less than 0.5%: a) bis(2-chloroethyl)amine hydrochloride; b) 3-(2-chloroethyl)-2-oxo-2-hydroxy-1,3,6,2-oxadiazaphosphonane; and c) 3-[2-(2-chloroethylamino)ethyl amino] propyl dihydrogen phosphate dihydrochloride. 2. The formulation of claim 1, further comprising an antioxidant. 3. The formulation of claim 2, wherein the antioxidant is monothioglycerol at concentration of about 0.01% to about 0.02% by total formulation weight. 4. A stable liquid parenteral formulation of cyclophosphamide comprising i. cyclophosphamide in a concentration of about 23% based on total formulation weight ii. an ethanol content of about 70% based on total formulation weight; iii. both polyethylene glycol and propylene glycol, wherein a polyethylene glycol to propylene glycol mass ratio is about 1.0:1.0; and iv. about 3.4% to about 8.8% based on total formulation weight of polyethylene glycol v. about 3.4% to about 4.4% based on total formulation weight of propylene glycol, and vi. about 0.02% based on total formulation weight of monothioglycerol.