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By Rakesh Gollen

Rakesh GollenBiologics represents a new category of drugs that have rapidly gained momentum in the past decade, as drugs of biological origin are increasing in the pharmaceutical arena. Peptides and proteins have become the drugs of choice for the treatment of numerous diseases due to their incredible selectivity and their ability to provide effective and potent action. In general, they cause few side effects, are highly specific, present limited interferences with normal biological processes, have low immunogenicity, and have great potential to cure diseases rather than merely to treat the symptoms. Apart from these benefits, from a business point of view, they hasten clinical development, and thus approval time, and they enjoy greater patent protection. Although the manufacturing of biologics has exhibited certain progress, particularly in the past decade, progress in the development of delivery systems able to improve the bioavailability of biologics remains rather limited.

Unlike conventional small molecular drugs, the clinical development of these types of drugs will not be possible without some sort of sophisticated pharmaceutical technology. Improved methods for the development, manufacture, and administration of drugs, particularly increasingly complex biologics such as protein and peptide therapeutics, are in demand now more than ever and are being met with advanced drug delivery options. The past decade saw an increased interest in formulating and delivering biological drugs for a range of diseases with significant unmet medical needs. Drug delivery methods play an increasingly significant role in the quest for new product opportunities as the pharmaceutical industry faces patent and pipeline challenges.

The nasal route of administration offers many advantages over the parenteral route of delivery of proteins and peptides as it is a noninvasive, highly vascularized, and convenient method of administration. It also avoids first-pass metabolism and, thus, allows for rapid pharmacokinetics. Intranasal delivery not only delivers a variety of therapeutics to the central nervous system (CNS) but also reduces systemic exposure and undesired side effects. Different formulations can also be used to facilitate the delivery of many poorly water soluble therapeutics to further reduce systemic exposure to therapeutics and to enhance delivery of therapeutics to the CNS. Nasal drug delivery devices have been developed to facilitate delivery to the upper third of the nasal cavity to enhance delivery of therapeutics to the CNS. These barriers need to be overcome to reach the full potential of using the nasal administration route as a primary method for the delivery of biologics.

A webinar by the AAPS Target Drug Delivery and Prodrug focus group, Targeting to the Brain: The Nose Knows, will focus on the noninvasive intranasal method of bypassing the blood-brain barrier (BBB) to deliver and target therapeutics (e.g., small molecules, peptides, proteins, oligonucleotides, stem cells, etc.) to the CNS to treat a variety of disorders, e.g., multiple sclerosis, epilepsy, Parkinson disease, Alzheimer disease, etc. This webinar will provide an introductory look at both the applied methods and the perspectives on many of the questions that a pharmaceutical scientist might have, as well as the issues they may face when undertaking such an endeavor. Register today to improve your knowledge in this specific but unexplored field of drug delivery!

Rakesh Gollen is currently pursuing his Ph.D. from Long Island University, with a major in Drug Metabolism and Pharmacokinetics, under the supervision of Dr. David Taft. His research focus is on the predictions of pharmacokinetic parameters in special population, using the physiologically based pharmacokinetics modeling approach.