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Mannitol as an Excipient for Lyophilized Injectable Formulations.

Seema Thakral¹, Jayesh Sonje¹, Bhushan Munjal¹

¹Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, United States of America.

Journal of Pharmaceutical Sciences

|August 28, 2022

Summary

Mannitol is a preferred excipient in lyophilized injectable formulations due to its physicochemical properties. Understanding its phase behavior and employing orthogonal techniques are key to overcoming challenges and achieving stable, cost-effective freeze-dried drug products.

Keywords:

Bulking agent Differential scanning calorimetry (DSC)Excipients Hydrate(s)Injectables Lyophilization Mannitol Polymorphs Sucrose Trehalose X-ray Powder diffraction (XRD)

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Area of Science:

Pharmaceutical Sciences
Materials Science

Background:

Mannitol is widely used as a bulking agent in lyophilized injectable formulations for both small and large molecules.
Its physicochemical properties offer advantages over other excipients like glycine.

Purpose of the Study:

To review the current knowledge on mannitol's role in lyophilized formulations.
To highlight challenges associated with mannitol use and propose mitigation strategies.
To emphasize the importance of understanding mannitol's phase behavior for optimizing freeze-drying cycles.

Main Methods:

Literature review of mannitol's properties and applications in lyophilization.
Analysis of mannitol's phase behavior in aqueous systems during freeze-drying.
Demonstration of orthogonal techniques for formulation development using a decision tree.

Main Results:

Mannitol's properties make it a desirable bulking agent, often preferred over glycine.
Challenges include potential vial breakage and the formation of metastable crystalline hemihydrate.
Understanding phase behavior is critical for optimizing freeze-drying cycles and ensuring product stability.

Conclusions:

Mannitol is a valuable excipient in lyophilized injectables, but its use requires careful consideration of potential challenges.
Optimizing freeze-drying processes through understanding phase behavior and employing appropriate techniques leads to stable and cost-effective products.