Recipharm is frequently asked to help its clients select and develop an appropriate dosage form for their inhalation product development programs.When choosing between metered dose inhaler (MDI), dry powder inhaler (DPI) and nebulised dosage forms, a wide range of technical, business and regulatory factors are worthy of evaluation. A few of those key considerations are discussed below
PHYSICOCHEMICAL FACTORS
Salt form screening is an important early step in inhalation dosage form selection.Approximately 50% of active pharmaceutical ingredients (APIs) in approved products are salt forms1, and that proportion is slightly higher (~ 60%) for APIs in approved inhalation products. For each type of formulation (e.g. solution versus suspension) or dosage form, it is conceivable that a different salt form will be most amenable for development. As with all pharmaceutical development, understanding the physical and chemical properties of the active pharmaceutical ingredient (API), and its different forms if applicable, is critical in defining the dosage form design space.Â
