IP Library Granted Patent US 11,931,370
Granted Patent B2
US 11,931,370 · App. 17/961,943 · Granted Mar 19, 2024

Stable pharmaceutical compositions of cyclophosphamide

Inventors: Shailendra Mandge (Hyderabad, IN); Harish Gunda (Nizamabad, IN); Naga Venkata Durga Prasad Ketha (Hyderabad, IN); Venkateshwar Reddy Keesara (Hyderabad, IN); Satheesh Balasubramanian (Hyderabad, IN); Sumitra Ashokkumar Pillai (Hyderabad, IN)
Assignee: SLAYBACK PHARMA LLC
A61K31/675A61K9/0053A61K9/08A61K47/10A61K47/14
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,931,370
App. No.
17/961,943
Granted
Mar 19, 2024
Kind
B2
Abstract

The present invention relates to stable liquid oral compositions of cyclophosphamide having extended stability, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cyclophosphamide. The invention also relates to a kit comprising stable liquid oral compositions of cyclophosphamide.

Claims (10)

1. A stable, ready-to-administer, liquid composition for oral administration comprising:

(i) cyclophosphamide at a concentration of about 10 mg/ml;

(ii) a non-aqueous lipid solvent is selected from a group consisting of phospholipids, medium-chain fatty acids, medium-chain fatty acid esters of glycerol, medium-chain fatty acid esters of polyethylene glycol, medium-chain fatty acid esters of propylene glycol, long-chain fatty acids, long-chain fatty acid esters of glycerol, long-chain fatty acid esters of polyethylene glycol, long-chain fatty acid esters of propylene glycol, or combinations thereof; and

(iii) a co-solvent selected from ethanol and glycerin;

wherein a concentration of the non-aqueous lipid solvent ranges from about 60% to 99% by weight of the composition;

wherein a concentration of the co-solvent is less than 10% by weight of the composition; and

wherein a level of total impurities in said liquid composition is less than 5% as determined by HPLC when stored at 2-8° C. for at least 3 months.

2. The composition of claim 1 , wherein the composition has a RC-A impurity of less than about 1% (w/w) as measured by HPLC, when stored at 2-8° C. for at least 3 months.

3. The composition of claim 1 , wherein the composition has a pH in the range of from about 3 to about 7.5.

4. The composition of claim 1 , wherein the liquid composition is a solution.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2025
From: SLAYBACK PHARMA LIMITED LIABILITY COMPANY
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 070877/0696 →
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Mar 17, 2025
From: ARBOR PHARMACEUTICALS, LLC; AZURITY PHARMACEUTICALS, INC.; AZURITY PHARMACEUTICALS IRELAND LIMITED; SILVERGATE PHARMACEUTICALS, INC.
To: HPS INVESTMENT PARTNERS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 070531/0487 →
RELEASE OF SECURITY INTEREST Recorded Mar 14, 2025
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: AZURITY PHARMACEUTICALS, INC.; SILVERGATE PHARMACEUTICALS, INC.; ARBOR PHARMACEUTICALS, LLC; SLAYBACK PHARMA LIMITED LIABILITY COMPANY
Reel/Frame 070521/0299 →
SECURITY INTEREST Recorded Sep 27, 2023
From: SLAYBACK PHARMA LIMITED LIABILITY COMPANY
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 065045/0560 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2023
From: MANDGE, SHAILENDRA; GUNDA, HARISH; KETHA, NAGA VENKATA DURGA PRASAD; KEESARA, VENKATESHWAR REDDY; SATHEESH BALASUBRAMANIAN, .; PILLAI, SUMITRA ASHOKKUMAR
To: SLAYBACK PHARMA LLC
Reel/Frame 063870/0244 →
Continuity (1)
Related Publication 20230119069A1 · Apr 20, 2023