Dissolving and coated microneedles as useful drug delivery platforms

Microneedles are a useful dosage form that combine key advantages of drug delivery by injection with advantages of transdermal drug delivery, while also overcoming some of the most notable limitations of these two therapeutic delivery modalities. Despite the potential utility of microneedles as a therapeutic dosage form, numerous challenges remain in satisfying the regulatory burden required to achieve FDA marketing approval. In Chapter 1, recent improvements in potentially scalable coating and manufacturing procedures for microneedles were reviewed. Advantages and limitations of certain types of microneedles, along with specific examples of manufacturing techniques were discussed, along with further improvements and regulatory considerations. In Chapter 2, an update on clinical development over the last five years including solid, coated, and dissolving microneedles was presented. Progress and results for selected clinical studies were discussed in detail.