An increasing number of therapies are targeting lung delivery for treatment of selected disease states. These include novel targets for improved treatment of asthma and COPD but also for localized infection and orphan disease states. The active pharmaceutical ingredients (API) being developed for these disease states span a broad range of physical/chemical properties and range in classification from small molecules to more complex milli-molecules to biomolecules ranging from siRNA to mAbs. Many of these new actives—due to poor crystallinity, poor stability, or narrow therapeutic index, are unsuitable for traditional inhalation processes and formulations.
Capsugel has developed a spray-dried engineered particle platform for the delivery of API with a broad range of physical properties to the lung. These engineered formulations allow for the manufacture of high fine particle fraction (FPF) formulations using a gentle process addressing key issues described above. This in turn allows for rapid formulation development and assessment. These formulations have been evaluated by Lovelace Respiratory Institute in a variety of select animal models including models for bronchoconstriction and fibrosis.
Case studies describing optimization of spray drying processes for manufacture of engineered particles will be shown in this presentation. In vitro characterization of these materials will be presented along with in vivo evaluation of the materials.