How innovative drug delivery devices can help realize clinical utility of new effective therapies

Modern methods of drug discovery employing highthroughput screening have led to numerous new chemical entities (NCEs) and biological molecules with significant therapeutic potential, which has led to new treatment options for patients and advance health care. However, properties of molecules such as poor solubilities, dosing regimen, and/or administration-related challenges limit successful patient/market uptake. Basic chemical approaches (e.g. prodrug synthesis) to the facilitation of oral absorption of NCEs have had limited success. On the other hand, advances in biotechnology have produced macromolecules/biologics whose hydrophilic character, high molecular weights, and short half-life necessitate frequent administration – mostly via injections. Such difficulties have hampered clinical development, reducing revenues for the pharmaceutical industry and denying patient access to novel treatments. Pharma companies patent new drugs early in the drug discovery process to protect their intellectual property. To continue their protection from the competition on the market, companies often tend to extend their patents by reformulating a drug. For example, controlledrelease delivery systems are often used to provide constant delivery for long term, produce localized therapeutic effect, reduce side effects, enhance efficacy of treatment, and improve patient compliance. Innovative manufacturing techniques can help realize novel drug delivery systems (DDSs) to provide potentially successful solutions to overcome the above challenges in the delivery of NCEs/biologics. The focus of this editorial will be on the use of innovative manufacturing technologies, such as 3D printing (3DP), electrospinning (ES), microfluidics (micro/nanoparticle formulation and chip manufacturing), and microelectromechanical systems (MEMS) to produce novel DDSs.