Dry Pharmaceutical Composition for Inhalation

Abstract

Vaccine administration is usually performed via intramuscular or subcutaneous injection. However, there are few challenges associated with this mode of delivery, such as a poor physico-chemical stability of the vaccine solution, which requires transportation and storage under temperature controlled conditions. This significantly increases vaccine (and health) cost as it dramatically limits vaccine availability, especially in developing countries. A dry- powder vaccine formulation is thermostable and easy to transport. Vaccine administration by injection can be painful, it may generate adverse psychosomatic effects (so called ‘lipothymic reaction’) and it must be performed by trained healthcare personnel. A dry-powder vaccine, instead, can be filled into monodose capsules and administered via ready-to-use inhalers. The technology uses a new formulation for the manufacturing of a respirable, dry-powder vaccine (i.e., containing both a recombinant antigen and an immune-stimulant) suitable for pulmonary administration. In addition to a greatly facilitated (i.e., unassisted) administration, this mode of delivery enhances immunogenicity and ultimately the efficacy of vaccination