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Manufacturing techniques and excipients used during the design of biodegradable polymer-based microspheres containing therapeutic peptide/protein for parenteral controlled drug delivery.

In the last couple of decades, use of biodegradable polymer-based microspheres has been recognized as an interesting and promising approach for parenteral controlled delivery of therapeutic peptide/protein, including antigens. The main objectives of this review are (i) to update the current state of art of manufacturing of peptide/protein-loaded microspheres through both conventional and newer microencapsulation techniques, and (ii) to bring into focus the various possible instability problems, and the investigated mechanistic ways to obviate the instability problems of peptide/protein drug during microspheres preparation as well as its release from the microspheres. The solubilization, stabilization, and preservation enhancing excipients that are used in peptide/protein-loaded microspheres are briefly overviewed.