Inhalable drug particles formulated as DPI and MDI devices for the treatment of COPD

Chronic obstructive pulmonary disease (COPD), is a severe disease characterised by chronic bronchitis, emphysema, fibrosis and mucous overproduction. In this lung disease, epithelial cells are induced to produce mucous which, together with other inflammation contributions, lead to airway obstruction and breathing problems. More and more research is focusing on COPD, due to its increase among the general population and its mortality. There are increasing evidences that statins are able to reduce the mortality in patients with COPD. The hypothesis put forward in this research is the possibility of using simvastatin for pulmonary administration. The aim of this project was to develop a new inhalation product (Dry Powder Inhaler †" DPI or Metered Dose Inhaler - MDI) containing simvastatin useful for the treatment of COPD and to investigate its advantages in improving pathological conditions of patients without systemic effects in comparison with an oral administration. The aim of the work was to demonstrate the rationale of local inhalation of simvastatin, its ability to penetrate into epithelial Calu-3, and simvastatin therapeutic effect in reducing mucus production. Moreover the aim of the work was also to find a new inhalation product (Dry Powder Inhaler or Metered Dose Inhaler) containing statins useful for the treatment of COPD. The local treatment should be novel to improve the pathological conditions of patients, without systemic effects due to oral administration.