ABSTRACT
A novel human recombinant antibody for prophylactic treatment against SARS-CoV-2 was formulated in a nasal solution comprising chitosan as mucoadhesive polymer. Two levels of protein concentration have been assessed and formulations loaded into Aptar VP3 nasal pump. The formulations produced showed values of pH (6.2- 6.3) and osmolality (414 and 421 mosm/kg) suitable to prevent precipitation of the antibody in the final solution and for nasal administration. Assay of the protein after formulation manufacturing showed a lower dimeric fraction than the reference standard and hydrodynamic diameter of the final formulations was also comparable to the unprocessed antibody solution (10 nm). Zeta-potential values were higher than 25mV, indicating colloidal stability against aggregation due to charge stabilization for the formulations obtained. Spray performance did not evidence any difference between protein levels in the final formulations when combined with VP3 nasal pump. Particularly, droplet size distribution (mean volume diameter of 55.13 lm for the low dose formulation and 57.21 lm for the high dose), spray pattern and plume geometry resulted to be applicable for nasal delivery. Finally, for both solutions sprayed antibody content was within 75-125% of the target delivered dose with a very low variability on ten consecutive shots (5%). Future studies will assess the formulations stability under refrigerated and ambient storage conditions of the combination product and of the antibody comprised in the formulation,whereas in vivo studieswill define pharmacokinetics and pharmacodynamics profile of these final formulations. Key Message: The possibility to deliver to the nose a novel human antibody for prophylactic treatment against SARS-CoV-2 employing Aptar VP3 pump was assessed. Spray performance of the formulations manufactured was characterized and no protein agglomeration was observed in the formulations and after spraying, indicating favourable results in applying this system for delivery of antibodies to the nose.