The growing number of biocompatible materials that are sensitive to physio- logical and external stimuli, as well as the versatility of current approaches to integrate them into DDSs, offer unprecedented possibilities for regulating the spatiotemporal release profile of the drugs. Stimuli-responsive DDSs make the delivery of drugs that have serious biopharmaceutical/toxicity constraints possible, and are expected to improve remarkably the therapeutic efficiency of old and new active substances. However, intelligent DDSs may have to face up to safety concerns andin vivo management of the responsiveness. The use of macromolecules (i.e. enzymes, antibodies or even synthetic polymers) with motifs that can be recognized by the immune system may lead to unexpected reactions in the body after successive administrations and may compromise the performance of the DDS and the health of the patient. Moreover, nano-sized entities produce additional safety concerns, and there is still a paucity of regulations about the assessment of the nanocarriers’ fatein vivo. Regarding applicability, intelligent DDSs have to fit the switching on/off of the release to the appearance/disappearance of the stimulus in order to avoid delays in the responsiveness.2 On the other hand, advances in portable trigger devices to activate externally DDSs that can be pre-programmed by nursing staff and/or are easy to use by the patients may improve the cost-effectiveness of the treatments.16
Overall, the positive and reliable information on the efficiency of intelligent DDSs coming from in vitro and cell culture assays is a valuable support to intensify the translation to animal models and even to clinical studies.189Such clinical translation should provide a better understanding of the behavior of the drugs formulated in intelligent DDSs and on how the body responds to the novel materials and therapy protocols. It can be foreseen that the information gathered underin vivoconditions serves as feedback for optimizing the features of the responsive materials and the design of more efficient DDSs.
From Drug Dosage Forms to Intelligent Drug-delivery Systems 25
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Acknowledgements
Work supported by MICINN (SAF2011-22771), Xunta de Galicia (10CSA203013PR) and FEDER.
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32 Chapter 1
Downloaded on 01/09/2013 10:25:46. Published on 25 April 2013 on http://pubs.rsc.org | doi:10.1039/9781849736800-00001
Materials Science and Engineering of the Low Temperature Sensitive Liposome (LTSL): Composition- Structure-Property Relationships That Underlie its Design and
Performance
DAVID NEEDHAM*
aAND MARK W. DEWHIRST
baDepartment of Mechanical Engineering and Material Science, Duke University, Durham NC 27705, USA, and DNRF Niels Bohr Professor, and HCA Academy Visiting Professor, University Southern Denmark, DK-5230 Odense M, Denmark;bGustavo S. Montana Professor, Director of Tumor Microcirculation Laboratory, Department of Radiation Oncology, Duke University Medical Center, Duke University, Durham, NC 27708, USA
*Email: [email protected]