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Preservative Induced Polysorbate 80 Micelle Aggregation.

Peter H Gilbert¹, Zhenhuan Zhang¹, Ken K Qian²

¹Department of Chemical and Biomolecular Engineering Department, Center for Neutron Science, University of Delaware, Newark, DE 19716; NIST Center for Neutron Research, National Institute of Standards and Technology, Gaithersburg, MD 20899.

Journal of Pharmaceutical Sciences

|January 2, 2021

Summary

This summary is machine-generated.

Preservative m-cresol destabilizes polysorbate 80 (PS80) micelles in pharmaceutical formulations, causing aggregation over weeks. Aggregation kinetics, influenced by temperature and pH, are crucial for formulation stability.

Keywords:

Micelles Pharmaceutical formulation Polysorbate Preservatives Small-angle neutron scattering

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Published on: October 10, 2016

Area of Science:

Pharmaceutical Science
Materials Science
Physical Chemistry

Background:

Protein formulation excipients like polysorbate 80 (PS80) are vital for drug stability.
M-cresol is a common antimicrobial preservative in multi-dose injectable formulations.
Understanding preservative-excipient interactions is critical for preventing drug product degradation.

Purpose of the Study:

To investigate the impact of m-cresol on polysorbate 80 (PS80) micelle stability.
To elucidate the kinetics and mechanism of preservative-induced micelle destabilization.
To quantify the temperature-dependence of PS80 micelle aggregation in the presence of m-cresol.

Main Methods:

Small-angle neutron scattering (SANS) was employed to study model pharmaceutical formulations.
Solutions of PS80 with and without m-cresol were analyzed.
Temperature-dependent SANS measurements were performed to study aggregation kinetics.

Main Results:

M-cresol addition induced turbidity and irreversible changes in PS80 micelle morphology.
Preservative-induced destabilization of PS80 micelles occurred slowly, over days to weeks.
SANS data revealed a two-step aggregation process: initial small aggregate formation followed by power-law growth.
Citrate buffer accelerated PS80 aggregation kinetics.

Conclusions:

Formulation stability is directly linked to the compatibility between excipients and preservatives.
The kinetics of aggregation play a significant role in preservative-surfactant interactions.
M-cresol's interaction with PS80 highlights the need for careful selection of preservatives in multi-dose formulations.