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Designing Inhalation Products to Satisfy Global Markets with Different Regional Requirements – Special Considerations for Asia

Venthoye G.

RDD Asia 2014. Volume , 2014: 143-150.

Abstract:

Product development teams often aim to design commercially viable orally inhaled products (OIPs) for multiple markets, following a Quality by Design (QbD) ethos and ideally targeting a single quality for all territories [1]. A single quality provides the greatest supply chain efficiencies and lowers cost through economies of scale, but can be difficult to achieve due to the significant differences in cost, quality, and regulatory requirements across the various countries. Designing the target product profile (TPP), product business plan, and manufacturing pathways in the first instance, with commercialization in the rest-of-world (ROW) territories in mind, and building in product robustness can help maximize an inhalation product’s commercial potential and patient access. flutiform® pMDI is available in multiple European and ROW countries. In Asia, the product is currently approved in Japan, Hong Kong, Singapore, Taiwan, and South Korea. The approval and launch experience of this product in Asia, as well as in Europe and ROW territories, has provided experience and insights into the specific opportunities and challenges which exist in developing and established markets. Some of these will be discussed in this article.