What is it about?
Several methods were developed to characterize the drug solids before they are reconstituted for injection to the patient. The addition of mannitol (a safe sugar alcohol) to the formulation along with certain processing was shown to reduce the reconstitution times of medications consisting of highly concentrated proteins, such as monoclonal antibody drugs. Furthermore, the mechanisms by which mannitol reduces the reconstitution time was elucidated. In short, when mannitol crystallizes out by proper processing, it provides patches that help draw in the fluid and provides weak points so the solid disintegrates to allow faster reconstitution.
Featured Image
Why is it important?
The reconstitution times of the more concentrated protein drugs can be very long (some as long as 40 minutes). In today's fast paced healthcare system, waiting for reconstitution is unacceptable. However, if the medication is injected into the patient before full reconstitution, there can be side effects. Reducing the reconstitution time of these medications allows efficient and safe administration to the patient.
Perspectives
While many insightful authors have speculated about the mechanisms by which mannitol improves reconstitution, this is the first study to quantitatively measure properties that were shown to be important factors for reconstitution time.
Prof Robin H Bogner
University of Connecticut
Read the Original
This page is a summary of: Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations, European Journal of Pharmaceutics and Biopharmaceutics, October 2018, Elsevier,
DOI: 10.1016/j.ejpb.2018.07.022.
You can read the full text:
Contributors
The following have contributed to this page
