Drug-device combination products

Device components, as part of a drug-device combination product, may contain polymers, elastomers, and other components from which minute quantities of material may migrate (leach) into the medicinal product over time and thus may affect the quality and safety of the product. A number of guidelines outline approaches to be considered for extractables and leachables studies [61, 62]. This chapter outlines additional points to consider specific to the development of drug-device combination products. 

An additional consideration for drug-device combination products is the potential need to undertake transportation studies (also referred to as agitation or rotational studies). This may be particularly relevant where the drug in such a combination product is a biological entity. Biological molecules can be more sensitive to transportation conditions than traditional small molecule medicinal products. In addition, medicinal products of a biological nature that are used in a combination product may raise specific concerns regarding transportation. In a situation where the... 

In this chapter we have highlighted some of the important considerations for developing stability strategies for drug-device combination products. It is vital to understand the latest regulatory requirements and expectations whilst also adopting a scientific and risk-based approach based on product understanding. 

Leppard, S. Regulation of drug-device combination products in Europe. In Drug-Device Combination Products. Delivery Technologies and Applications-, Lewis, A., Ed. Woodhead Publishing Limited and CRC Press LLC Boca Raton, FL, 2010 pp. 464-495. 

Additionally, as governing agencies such as the Food and Drug Administration step up their scrutiny of medical devices and drug-device combination products with respect to biocompatibility and stability, surface analysis will probably play an increasing role in characterizing the surfaces that come into direct contact with a patient. 

---