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Poly(ethyleneglycol) 500 Dimethylether as Novel Solvent for Injectable In Situ Forming Depots
Low hemolytic potential, suitable viscosity for injection, stability of PLGA solutions in PEG 500DME and the correlation between phase separation and in vitro release confirmed the potential of PEG500DME as a promising solvent for ISFD.
Biocompatibility of an injectable in situ forming depot for peptide delivery.
The functionality of the ISFD containing PEG 500DME as a novel solvent was demonstrated in vitro and in vivo and the local tolerability of the system confirmed the biocompatibility of PEG500DME in parenteral depots.
Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products
This work presents a systematic approach to late-stage drug product, especially formulation development using three monoclonal antibody examples, and results generated using these approaches strengthen the data packages to support specifications and manufacturing ranges and hopefully simplify implementation of postapproval changes.