First in vivo evaluation of particulate nasal dry powder vaccine formulations containing ovalbumin in mice.

In this study three different dry powder vaccine formulations containing the model antigen ovalbumin were evaluated for their immune effects after nasal administration to C57Bl/6 mice in an adoptive cell transfer model. The formulations were chitosan nanoparticles in a mannitol matrix, chitosan microparticles and agarose nanoparticles in a mannitol matrix. Dry powder administration to mice was well tolerated and did not result in any adverse reactions.

Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products.