Quality attributes of CTVad1, a nanoemulsified adjuvant for phase I clinical trial of SpiN COVID-19 vaccine.

Aim: To develop, characterize and evaluate an oil/water nanoemulsion with squalene (CTVad1) to be approved as an adjuvant for the SpiN COVID-19 vaccine clinical trials. Materials & methods: Critical process parameters (CPPs) of CTVad1 were standardized to meet the critical quality attributes (CQAs) of an adjuvant for human use. CTVad1 and the SpiN-CTVad1 vaccine were submitted to physicochemical, stability, in vitro and in vivo studies. Results & conclusion: All CQAs were met in the CTVad1 production process. SpiN- CTVad1 met CQAs and induced high levels of antibodies and specific cellular responses in in vivo studies. These results represented a critical step in the process developed to meet regulatory requirements for the SpiN COVID-19 vaccine clinical trial.

Biodegradable Electrospun Nanofibers: A New Approach For Rhinosinusitis Treatment.

Biodegradable polymeric nanofibers containing mometasone furoate can be a new approach to drug delivery to treat chronic rhinosinusitis, providing controlled steroid delivery to the sinonasal mucosa. This study aimed to develop biodegradable polymeric nanofibers and explore the safety of these fibers in an in vivo rabbit model. The nanofibers' development has been optimized using the Response Surface Methodology (RSM) obtained with Design of Experiments (DoE) with the best conditions related to the polymer concentration and proportion of solvents used in the electrospinning process. The nanofibers were prepared, operating as a determinant factor, the nanofiber formation and its diameter evaluated by Scanning Electron Microscopy (SEM). The ideal system obtained was assessed by SEM, thermogravimetric analysis (TGA), X-ray diffraction (XRD), differential scanning calorimetry (DSC), assay, and drug delivery by UHLPC validated method. The results showed that the drug is dispersed in the polymeric matrix, is stable, and showed sustained release kinetics in a bio-relevant nasal environment (Higuchi model kinetics). In vivo tests, the level of inflammation at the animals' mucosa which received the nanofiber with the mometasone furoate was lower than those that received the nanofibers without the drug (α = 0.05). Histopathology analysis showed that the polymeric nanofibers containing mometasone are safe when topically applied on the sinonasal mucosa, opening a new horizon in chronic rhinosinusitis treatment.