1052_GF_ONdrugDelivery Issue 50_01_04.indd
نویسنده
چکیده
As a result of the regulatory focus on using a Quality by Design (QbD) approach for ANDAs, generics manufacturers are placing increasing emphasis on the analytical tools that support its application. Most especially, there is a requirement for analytical technologies that help to scope the product design space efficiently. This is the multiparametric space in which the properties that define clinical performance must lie to ensure consistent, controlled efficacy. When developing nasal sprays, identifying the design space is complicated by the fact that critical features of the delivered dose, such as droplet size, are influenced by interactions between the formulation and the delivery device used. A detailed understanding of the impact of both of these elements is essential to achieving the QbD, knowledge-led approach now associated with successful development and commercialisation of a generic. Here, we examine the complementary use of laser diffraction particle sizing, automated imaging and rheological characterisation to gather the information needed both for generic nasal spray development and the demonstration of bioequivalence. In combination these techniques help to elucidate the factors defining product performance. This enables efficient manipulation of the formulation properties and the features of the device in order to meet development targets.
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تاریخ انتشار 2014