Storage-stable ready-to-use injectable formulations of thiotepa

US11260065B2 · kind B2 · utility

Assignee

• RK Pharma Solutions LLC · US

Inventors

• Ravishanker Kovi · Sparta, US
• George Roby Thomas · Winnipeg, CA
• Nirmal Chaitanya Indravadanbhai · Sayla, IN
• Patel Mitesh Manubhai · Sayla, IN
• Thupalli Ajeykumar Reddy · Bengaluru, IN
• Jayaraman Kannappan · Mahesana, IN

Key dates

• Filing date: Nov 21, 2019
• Grant date: Mar 1, 2022
• Expiry date: Apr 11, 2040

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K47/10
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

A stable, ready-to-use injectable solution including thiotepa and one or more pharmaceutically acceptable solvents, co-solvents, and/or solubilizing agents. Formulations retain at least 90% and as high as 99% of the purity of thiotepa as measured by HPLC after storage at 25° C./60% RH for a period of 7 days. Certain formulations retain at least 99% of the purity of thiotepa as measured by HPLC after storage for at least six months at 2-8° C.