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Pharmaceutical interfaces: Drug development, performance, regulation and e-health

Authors : Diane J. Burgess

Interfaces have always been of concern with respect to the delivery of bioactives. Interfaces within the delivery system that can affect stability are a concern; however, there are other interfaces of importance, such as the interface with the body tissue, the regulatory interface and the emerging interface when drug delivery is linked to e-health applications. This presentation will address all these interfaces covering basic science aspects as well as discussion of e-health applications. There are interfaces between different phases in formulations such as emulsions, foams, suspensions etc. There are interfaces between actives and excipients within a formulation. The actives as well as excipients may be in different states. The interfaces can be areas of weakness within a formulation with consequent stability concerns resulting from phase change, and incompatibilities such as relative hydrophilicity/lipophilicity. The interface between the body and the delivery system can vary with the dosage form characteristics as well as the route of administration. The tissue/device interface has implications in the foreign body response or lack thereof. Another important interface is that between the industry and the regulatory authorities, and what we need to understand in terms of device performance testing and safety. With the e-health revolution, it is important to understand the implication to drug delivery science. This presentation will focus on: 1) formulation issues related to stability at interfaces; 2) the interface of drug delivery devices with the body and overcoming the foreign body response; and 3) the interface with the regulatory authorities in terms of performance indicating tests for controlled release parenteral products; and 4) the e-health interface.

Peer review under responsibility of Shenyang Pharmaceutical University.

Keywords

Pharmaceutical interfaces; Drug development; E-health

Citation: Diane J. Burgess Pharmaceutical interfaces: Drug development, performance, regulation and e-health doi:10.1016/j.ajps.2015.10.003

Available online 5 November 2015

Copyright: © 2016 Production and hosting by Elsevier B.V. on behalf of Shenyang Pharmaceutical University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

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