Stable pharmaceutical compositions of bendamustine

US11707450B1 · kind B1 · utility

Assignee

• Slayback Pharma LLC · US

Inventors

• Harish Govindaraja Setty Chinnari · Hyderabad, IN
• Somashekhar Battini · Hyderabad, IN
• Sumitra Ashokkumar Pillai · Hyderabad, IN
• Lourdu Chinnu Thippabattuni · Hyderabad, IN
• Satheesh Balasubramanian · Hyderabad, IN

Key dates

• Filing date: Jul 29, 2022
• Grant date: Jul 25, 2023
• Expiry date: Jul 29, 2042

Classification

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

Abstract

Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine or its pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.