Stability evaluation of protein drugs in optimised thiolated-chitosan based buccal xerogels
The stability profiles of BSA and INS incorporated in lyophilised chitosan-based buccal xerogels have been evaluated using Bradford’s Assay as well as SE-HPLC and RP-HPLC quantification for BSA and INS respectively. Chromatographic conditions were; Agilent 1100 series, Tosoh TSK-GEL PW column (7.8 x 300mm, 10 µm), mobile phase PBS, flow rate 1 mL/min, wavelength 215 nm (SE-HPLC); Agilent 1200 with a Jupiter 5-μm C18 column (250mm x 4.6 mm), mobile phase-water: acetonitrile (67:33v/v) 0.1%TFA; flow rate-1 mL/min; and wavelength-220nm (RP-HPLC). The use of SE-HPLC and RP-HPLC methods for BSA and INS respectively showed chromatograms indicating that storage of xerogels using accelerated stability conditions at 25 °C/ 60 % RH for six months resulted in substantial loss of native protein. Storage of
xerogels at 5 °C in a refrigerator maintained protein stability up to six months. Bradford’s assay for protein quantification was not stability indicating method as it was not specific for the determination of degraded protein products from all xerogels.
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