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Device Design Development and Quality by Design

Dundon A, Swanbury P, Willoughby M, de Kruijf W.

Respiratory Drug Delivery 2014. Volume 1, 2014: 205-216.

Abstract:

Over the last few years, guidance has been provided to industry by the International Committee on Harmonization (ICH) describing quality by design (QbD) principles that can be applied to the development of drug products, including risk-based approaches, described by ICH Q8, Q9, Q10, and Q11, respectively. Numerous papers have been published which demonstrate that a relatively common understanding and implementation has been adopted by industry during the development of simple oral dosage forms. However, there has been less direction, or examples cited, of how this guidance can be adopted for more complex dosage forms such as drug delivery devices, including combination products. A process developed by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) is described for a QbD approach to define the Design Space for a drug delivery device. The process is aligned with the principles described in Q8, Q9, Q10, and Q11, and is independent of the type of drug delivery device (i.e., inhaler, injector, nasal spray, etc.). Examples are provided which illustrate the application of this process to the design, development and industrialization of the ElliptaTM dry powder inhaler (DPI) (GlaxoSmithKline, Ware, UK). The process described is designed to provide regulators with confidence about the Design Space within which the device will be controlled in order to meet a drug product’s critical quality attributes, and that the limits defined have informed the registered specification. Furthermore, the approach provides the sponsoring company with confidence about the robustness of the device design as it is scaled from clinical trial supply through to commercial supply.