Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers
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The study examined the sensitivity of DPI in vitro performance to formulation and device changes. Rotahaler/Rotacaps was selected as the reference DPI drug product, and Aerolizer was selected as the test device. Since the test device was recognized to have much greater efficiency of dispersion, simple modifications to both formulation and device were made in an effort to provide a closer match to the in vitro performance of the reference product. The modifications included varying the drug and lactose particle sizes and/or lactose fine particle content in the test formulations, as well as lowering the specific resistance of the test device. These modifications were intended to address variables important for drug product performance for a defined experimental design and were not intended to mimic the extensive formulation and device design strategies that are employed in an industrial setting. Formulation and device modifications resulted in a modified test product that approached the reference product in the in vitro performance.
KEY WORDSdevice modifications dry powder inhaler formulation generic in vitro performance
We would like to thank Maureen Stewart, Visual Information Specialist, CDER, FDA, Silver Spring, MD, for preparing the illustrations of the two Modified Aerolizers.
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