Regulatory Pathway for Generic Inhalation Drug Products
Author:
Dr Justine Ramsden
Principal Consultant
Introduction
Pulmonary drug delivery has been primarily the delivery of choice for the treatment of local conditions or diseases active in the respiratory tract for over 70 years. For local activities, inhaled drugs are delivered directly to the site of action in the lung, providing fast onset of action.
Traditionally small molecules were considered for this route of administration. In the case of systemic drug delivery via inhalation as the lung provides the advantage of large alveolar epithelial absorption area with low enzymatic activity, this route is also suitable route for more complex molecules such as biological products (antibodies, vaccines and oligonucleotides).