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Pharm Res. 2011 Jul;28(7):1765-73. doi: 10.1007/s11095-011-0411-z. Epub 2011 Mar 18.

Lyophilization of protein-loaded polyelectrolyte microcapsules.

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  • 1Laboratory of General Biochemistry and Physical Pharmacy, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.

Abstract

PURPOSE:

To evaluate if lyophilization can be used to obtain a dry formulation of polyelectrolyte microcapsules, which have emerged as a new class of microparticles for the encapsulation and delivery of biomacromolecules.

METHODS:

Microcapsules composed of dextran sulfate and poly-L-arginine were obtained by coating CaCO(3) microparticles by means of the layer-by-layer technique. Microcapsules were lyophilized using different stabilizers; intactness was checked by CLSM and SEM. Horseradish peroxidase was encapsulated as model enzyme and retained activity after freeze-drying was determined using a fluorescence assay. Ovalbumin was encapsulated as model antigen; immunogenicity after lyophilization was evaluated in vitro by a T-cell proliferation assay and in vivo by measuring the antibody titer in mice.

RESULTS:

The results clearly demonstrate the necessity of using polyols in the formulation to prevent rupture of the microcapsules and to preserve the activity of encapsulated enzymes. Lyophilized microcapsules appeared as a promising adjuvant for antigen delivery, as both in vitro as in vivo assays showed higher immune activation compared to free antigen.

CONCLUSIONS:

Lyophilization is a promising strategy towards improved stability of protein-loaded microcapsules.

PMID:
21424158
[PubMed - indexed for MEDLINE]
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