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Formulation of biologics for alternative routes of administration: Current problems and perspectives

By
Sanja Stanković ,
Sanja Stanković
Marija Tasić-Kostov Orcid logo
Marija Tasić-Kostov

Abstract

Biologics (biopharmaceuticals) present new promising therapies for many diseases such as cancers, chronical inflammatory diseases and today's biggest challenge - COVID-19. Today, most biologics have been synthetized using modern methods of biotechnology, in particular DNA recombinant technology. Current pharmaceutical forms of protein/peptide biopharmaceuticals are intended for parenteral route of administration due to their instability and large size of molecules. In order to improve patient compliance, many companies are working on developing adequate forms of biopharmaceuticals for alternative, non-invasive routes of administration. The aim of this work is to review current aspirations and problems in formulation of biopharmaceuticals for alternative (non-parenteral) routes of administration and to review the attempts to overcome them. These alternative routes of administration could be promising in prevention and treatment of COVID-19, among other serious diseases. The emphasis is on stabilizing monoclonal antibodies into special formulations and delivery systems; their application should be safer, more comfortable and reliable. When it comes to hormones, vaccines and smaller peptides, some companies have already registered drugs intended for nasal and oral delivery.

References

1.
Hoyer H, Perera G, Bernkop-Schnürch A. Noninvasive delivery systems for peptides and proteins in osteoporosis therapy: a retroperspective. Drug Development and Industrial Pharmacy. 2010;36(1):31–44.
2.
Pharma I. Enabling Technologies for Precision Drug Delivery in the GI Tract.
3.
Annabestani Z, Sharghi S, Shahbazi S, Karimi F, Taheri E, Heshmat R, et al. Insulin buccal spray (Oral-Lyn) efficacy in type 1 diabetes. J Diab Metabolic Dis. 2010;9(18).
4.
Corp GB. Active Comparator Study of Generex Oral-lynTM Spray and Injected Human Insulin. 2008;
5.
Bajracharya R, Song JG, Back SY, Han HK. Recent Advancements in Non-Invasive Formulations for Protein Drug Delivery. Computational and Structural Biotechnology Journal. 2019;17:1290–308.

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Citations

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