A history of DPI capsule filling
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The second in a series of articles on the history of DPI capsules. Part I appeared in the December, 2008 issue of Inhalation.
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General Features
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In vitro nasal spray characterization
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While the relationship between certain spray characteristics and the therapeutic effect of a product is still under investigation, the FDA currently requires numerous techniques for characterizing the nasal spray drug product for New Drug Applications (NDAs). Submissions of Abbreviated New Drug Applications (ANDAs) also require a subset of these tests to demonstrate in vitro bioequivalence for locally-acting nasal sprays. This article discusses the optimum timing of spray characterization studies during nasal spray product development.
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Selecting a nasal spray pump
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Making sure that a nasal spray pump is appropriate for the formulation and choosing a high-performing, well-characterised, and reliable device can minimize challenges and speed up time to market. This article reviews factors to consider in selecting a device.
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The abbreviated impactor measurement concept
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This article describes the abbreviated impactor measurement (AIM) concept and how the method can serve as a viable alternative to full resolution cascade impactor (CI) measurement.
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