Spray drying of virosomes for nasal and oral powder
Excipients were added to the GMP virosome feed stock solution for spray drying. The nasal powder formulation was obtained by adding trehalose and sodium alginate (mucoadhesive excipient) to the liquid virosomes MYM-V202 at an excipient loading to achieve 77 and 8% w/w, respectively. The oral powder formulation was obtained by adding trehalose 87% w/w. During spray drying the outlet temperature was set at 60?°C, using an inlet temperature of 85–90?°C. Final bulk powders were overlaid with nitrogen gas and stored at 2–8?°C, double bagged in foil pouches for light protection. Following analysis, glass vials and Aptar dry powder nasal devices were loaded with various amount of powder to fit the need of the animal and stability studies, then closed and sealed into double-bagged foil pouches for light and moisture protection. Depending on the need, samples were stored under various temperature and relative humidity (RH) conditions: 4?°C, 25?°C/60% RH, and/or 40?°C/75% RH. Each mg of GMP nasal and oral powder contained 0.50?µg HA, 1.5?µg P1, 0.83?µg rgp41, and 0.50?µg 3M-052, in HN buffer pH 7.4. Powders were then evaluated by industrial analytical methods and standards in place at Upperton (Supplementary Tables 1 and 2) such for the powder particle size, moisture content, endotoxin level, or/and microbiological purity. Non-GMP batch sizes were the equivalence of 100–500 vaccine doses and for GMP batch the equivalence of 500 doses (enough for a Phase I trial).
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