4.8 Article

Delivery of biologics: Topical administration

Journal

BIOMATERIALS
Volume 302, Issue -, Pages -

Publisher

ELSEVIER SCI LTD
DOI: 10.1016/j.biomaterials.2023.122312

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Biologics are often unaffordable due to high costs of fermentation, purification, and cold chain requirements. During the pandemic, limitations in production and delivery systems were evident, with a small percentage of vaccines reaching low-income countries and doses being wasted due to lack of cold-chain infrastructure. Most FDA-approved biologics are delivered invasively, while oral or topical drugs are preferred by patients. However, only a few oral drugs have been approved since 2015. The recent launch of an oral biologic with significantly reduced costs highlights the potential for simplified regulatory processes. Topical delivery offers targeted delivery of high concentration protein drugs, but there are limited FDA-approved options. This review discusses advancements in oral and topical delivery methods and suggests future directions for research.
Biologics are unaffordable to a large majority of the global population because of prohibitively expensive fermentation systems, purification and the requirement for cold chain for storage and transportation. Limitations of current production and delivery systems of biologics were evident during the recent pandemic when <2.5% of vaccines produced were available to low-income countries and similar to 19 million doses were discarded in Africa due to lack of cold-chain infrastructure. Among FDA-approved biologics since 2015, >90% are delivered using invasive methods. While oral or topical drugs are highly preferred by patients because of their affordability and convenience, only two oral drugs have been approved by FDA since 2015. A newly launched oral biologic costs only similar to 3% of the average cost of injectable biologics because of the simplified regulatory approval process by elimination of prohibitively expensive fermentation, purification, cold storage/transportation. In addition, the cost of developing a new biologic injectable product (similar to$2.5 billion) has been dramatically reduced through oral or topical delivery. Topical delivery has the unique advantage of targeted delivery of high concentration protein drugs, without getting diluted in circulating blood. However, only very few topical drugs have been approved by the FDA. Therefore, this review highlights recent advances in oral or topical delivery of proteins at early or advanced stages of human clinical trials using chewing gums, patches or sprays, or nucleic acid drugs directly, or in combination with, nanoparticles and offers future directions.

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