You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 31, 2025

Claims for Patent: 10,993,952

✉ Email this page to a colleague

« Back to Dashboard

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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.