Journal
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
Volume 46, Issue 3, Pages 403-411Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/03639045.2020.1724131
Keywords
Spray freeze-drying; IgG; HP beta CD; surface activity; direct binding; aerosolization
Categories
Ask authors/readers for more resources
The great potential of hydroxypropyl beta-cyclodextrin (HPssCD), as a dried-protein stabilizer, has been attributed to various mechanisms namely water-replacement, vitrification and surfactant-like effects. Highlighting the best result in our previous study (weight ratio IgG: HPssCD of 1:0.4), herein we designed to evaluate the efficacy of upper (1:2) and lower (1:0.05) ratios of HPssCD in stabilization and aerosol properties of spray freeze-dried IgG. The protective effect of HP beta CD, as measured by size exclusion chromatography (SEC-HPLC) was most pronounced at C3 ' and C3 '', IgG:trehalose:HP beta CD ratios of 1:2:0.25 and 1:2:0.05 with aggregation rate constants of 0.46 +/- 0.02 and 0.58 +/- 0.01 (1/month), respectively. The secondary conformations were analyzed through Fourier transform infrared spectroscopy (FTIR) and all powders well-preserved with the lack of any visible fragments qualified through sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PPAGE). Scanning electron microscopy (SEM) and twin stage impinger (TSI) were employed to characterize the suitability of particles for further inhalation therapy of antibodies and the highest values of fine particle fraction (FPF) were achieved by C3 ' and C3 '', 56.43 and 48.12%. The powders produced at the current ratio 1:2:0.25 and 1:2:0.05 are superior to our previous examination with regards to manifesting lower aggregation and comparable FPF values.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available