Preformulation Aspects On Inhalation Drug Delivery System Design

Due to the diverse nature of inhalation dosage forms, preformulation as applied to the development of inhalation formulations can be extremely broad in scope. Although a good deal of relevant information of a generic nature (i.e., pKa, log P) would typically be generated during preliminary physicochemical profiling of a drug substance [3], specialized information specific to the intended dosage form is also required.

The importance of identifying the mode of delivery to the lung (i.e., nebulizer, MDI, DPI) as early as possible cannot be overemphasized. A drug salt form selected assuming development of a propellant-based MDI suspension formulation may be wholly unsuited for application in an aqueous-based nebulizer suspension on the basis of solubility and crystal growth potential. Physicochemical properties and stability issues considered to be of importance in the development of inhalation formulations are discussed later, as they relate to the individual dosage forms.

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