Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses.

Abstract:

:In this study, we investigated the potential roles of nanoparticles (<100 nm) and submicron (100-1000 nm) particles in the formation of microparticles (>1000 nm) in protein formulations under some pharmaceutically relevant stress conditions. Exposure of intravenous immunoglobulin solutions to the interface-associated stresses of freeze-thawing or agitation resulted in relatively large increases in microparticle concentrations, which depended directly on the levels of pre-existing nano- and submicron particles. Thus, agglomeration of nanoparticles and submicron particles appears to play a role in microparticle formation under these stresses. In contrast, increases in microparticle concentrations during quiescent incubation at elevated temperatures were independent of the initial nano- and submicron particle concentrations in solution.

journal_name

J Pharm Sci

authors

Pardeshi NN,Zhou C,Randolph TW,Carpenter JF

doi

10.1016/j.xphs.2018.03.016

subject

Has Abstract

pub_date

2018-07-01 00:00:00

pages

1852-1857

issue

7

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(18)30156-4

journal_volume

107

pub_type

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