The Increasing Interest in Drug Device Interactions
Traditionally, the main area of concern regarding interactions between a formulation and a device has been limited to the container storage system for the formulation. There is mounting interest in the interaction of drugs on devices and vice versa, when they are used in close proximity.
Extractables and leachables studies are applied to pharmaceutical containers and production equipment. The goal is to detect any chemicals emanating from these systems which might degrade the API or in some way harm the end user. This is supported by stability studies which examine degradation and the possibility of the transfer of materials between the container and the dosage form, such as adsorption of the API.
Attention is now growing regarding the effects of drugs on the performance of devices and the influence of combination devices on drug efficacy and safety. It is possible that formulations contain chemicals which diminish device performance. Examples of this could be the weakening of sutures or the stress cracking of implant materials which are contacted by undiluted formulation. Equally, a device might have a catalytic or inhibiting effect on a pharmaceutical. For example, biosimilar proteins may be denatured by a delivery system or some other in-situ device.
MET is a laboratory uniquely equipped to study these interactions at the boundary between medical devices and pharmaceutical analysis.