Recent advances in oral delivery of biologics: nanomedicine and physical modes of delivery

ABSTRACT

Introduction: Research into oral delivery of biologics has a long and rich history but has not produced technologies used in the clinic. The area has evolved in terms of strategies to promote oral biologics delivery from early chemical absorption enhancers to nanomedicine to devices. Continued activity in this area is justifiable considering the remarkable proliferation of biologics.

Areas covered: The article discusses some physiological barriers to oral delivery of biologics, with a special focus on less characterized barriers such as the basement membrane. Recent progress in oral delivery of biologics via nanomedicine is subsequently covered. Finally, the emerging field of device-mediated gastrointestinal delivery of biotherapeutics is discussed.

Expert opinion: Oral delivery of biologics is considered a ‘panacea’ in drug delivery. Almost century-old approaches of utilizing chemical absorption enhancers have not produced clinically translated technologies. Nanomedicine for oral biologics delivery has demonstrated potential, but the field is relatively new, and technologies have not progressed to the clinic. Device-mediated oral biologics delivery (e.g. ultrasound or microneedles) is in its infancy. However, this space is likely to intensify owing to advances in electronics and materials, as well as the challenges and history related to clinical translation of alternative approaches.

KEYWORDS:

• Absorption enhancement
• biologics
• microneedle capsule
• nanomedicine
• oral delivery of biologics
• ultrasound

Article highlights

• The absence of clinically used technologies for oral delivery of biologics despite long research activity in the field highlights the scale of the challenge of overcoming the physiological barriers of the gastrointestinal tract for successful delivery.

• Many chemical absorption enhancer strategies for oral biologics delivery are limited to in vitro success.

• Some physiological barriers, such as the basement membrane, require further evaluation, particularly if nanomedicine approaches are utilized to improve delivery.

• Nanomedicine shows potential for oral biologics delivery but is associated with yet to be addressed issues of safety, delivery capacity, and regulatory approval.

• Device-mediated oral delivery of biologics (e.g. ultrasound or microneedles) is in its infancy but shows promising signs and is attracting the attention of the Biopharma industry.

• Future growth in research activity on oral biologics delivery devices is likely and this will be facilitated by advances in electronics, robotics, and materials, as well as the lack of success of alternative approaches.

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded