Abstract
The success of protein, peptide and antibody based therapies is evident - the biopharmaceuticals market is predicted to reach $388 billion by 2024 [1], and more than half of the current top 20 blockbuster drugs are biopharmaceuticals. However, the intrinsic properties of biopharmaceuticals has restricted the routes available for successful drug delivery. While providing 100% bioavailability, the intravenous route is often associated with pain and needle phobia from a patient perspective, which may translate as a reluctance to receive necessary treatment. Several non-invasive strategies have since emerged to overcome these limitations. One such strategy involves the use of microneedles (MNs), which are able to painlessly penetrate the stratum corneum barrier to dramatically increase transdermal drug delivery of numerous drugs. This review reports the wealth of studies that aim to enhance transdermal delivery of biopharmaceutics using MNs. The true potential of MNs as a drug delivery device for biopharmaceuticals will not only rely on acceptance from prescribers, patients and the regulatory authorities, but the ability to upscale MN manufacture in a cost-effective manner and the long term safety of MN application. Thus, the current barriers to clinical translation of MNs, and how these barriers may be overcome are also discussed.
Highlights
Protein and peptide based drugs are primarily administered via the parenteral route, as this provides rapid drug delivery, and in the case of the intravenous route, 100% bioavailability
The study effectively demonstrated that the two physical methods of permeation enhancement could increase transdermal delivery of macromolecules, the addition of sonophoresis to MNs removes some key advantages of MNs, namely the ability for self-administration and the convenience associated with the small array
The results demonstrated that repeat hydrogel-forming MN application does not lead to prolonged skin reactions or prolonged disruption of skin barrier function
Summary
The increasing development and use of protein based therapies over the last few decades can be attributed to the improvement of protein expression and synthesis on the scale required for widespread manufacturing [1,2].
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