The interface of medical devices and pharmaceuticals: Part I: this two-part article considers the complexities of developing and commercializing combination products using examples from experience with drug-eluting stents and drug-eluting beads. Part I discusses the technical challenges of developing these products.(design)

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Combination products

The concept of a combination product is not new. Traditionally, devices have been used in conjunction with pharmaceutical actives primarily as a means of modulating delivery. From simple syringes to more complex nebuliser designs or implantable pumps, the objective has remained the same: to deliver a known and controlled dose of active to a particular site in the body. There has been, however, a distinct change in the point where drug and device are united and in the purpose of the combined product. In particular, for devices that come into contact with body tissues, whether temporarily or as permanent implants, there has ...

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