Mannitol as an Excipient for Lyophilized Injectable Formulations.

Seema Thakral, Jayesh Sonje, Bhushan Munjal, Bakul Bhatnagar, Raj Suryanarayanan

Journal of pharmaceutical sciences 2023 Jan

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The review summarizes the current state of knowledge of mannitol as an excipient in lyophilized injectable small and large molecule formulations. When compared with glycine, the physicochemical properties of mannitol make it a desirable and preferred bulking agent. Though mannitol is a popular bulking agent in freeze-dried formulations, its use may pose certain challenges such as vial breakage or its existence as a metastable crystalline hemihydrate in the final cake, necessitating appropriate mitigation strategies. The understanding of the phase behavior of mannitol in aqueous systems, during the various stages of freeze-drying, can be critical for the optimization of freeze-drying cycle parameters in multi-component formulations. Finally, using a decision tree as a guiding tool, we demonstrate the use of orthogonal techniques for attaining a stable and cost-effective lyophilized drug product containing mannitol. Copyright © 2022 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

Citation

Seema Thakral, Jayesh Sonje, Bhushan Munjal, Bakul Bhatnagar, Raj Suryanarayanan. Mannitol as an Excipient for Lyophilized Injectable Formulations. Journal of pharmaceutical sciences. 2023 Jan;112(1):19-35