Stable pharmaceutical compositions of bendamustine

US12059406B2 · kind B2 · 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: Nov 6, 2023
• Grant date: Aug 13, 2024
• Expiry date: Nov 6, 2043

Classification

• Technology area (CPC —): General

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, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or 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.