In Vitro and In Vivo Techniques Used in Drug Develpoment for Evaluation of Dose Delivery of Inhales Corticosteroids

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Oral inhaled corticosteroids are important in the treatment of asthma since their delivery is targeted directly to the lung, which is the site of action. Triamcinolone acetonide (TAA) is am effective and safe corticosteroid that is marketed as a metered-dose inhaler (MDI) with an integrated spacer (Azmacort®) for the treatment of asthma. Due to the phasing out of chlorofluorocarbon (CFC) propellants. Azmacort® has been reformulated with a non-CFV propellant. Due to the complexities of oral inhaled fromulations and the topical nature of drug delivery to the lung for efficacy, the reformulation of oral inhaled MDIs requires careful consideration and support throughout their development, using a combination of in vitro and in vivo studies to ensure clinical comparability for both efficacy and safety. This paper describes a chronological series of studies designed to support the reformulation of Azmacort®. These included in vitro studies to estimate respirable fraction, in vivo pulmonary deposition studies, in vivo pharmacokinetic-pharmacodynamic studies to estimate the systemic effects of each formulation, and final clinical studies in adult and pediatric patients to confirm the clinical comparability of the new formulation of Azmacort®. The results of these studies, performed at various stages during the development of new formulations, were critical in guiding the reformulation efforts for Azmacort®.

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