CNS Pathways
Currently, there are more than 30 companies involved in the development of therapeutics for delivery to the brain via nasal deposition. Central nervous system (CNS) therapeutic indications include, but are not limited to, anxiety, epilepsy, Alzheimer's disease, Parkinson’s disease, migraine, multiple sclerosis and depression. In the treatment of depression, for example, nearly 300 million people of all ages, globally, are affected by major depressive disorder (MDD) and have not responded adequately to traditional therapies. Now a new esketamine nasal spray treatment has received FDA approval for MDD with imminent risk for suicide, which demonstrates continued applications for the safe and effective use of nasal sprays for these conditions. CNS diseases represent a huge emotional, financial and social burden to patients, their families, health care providers and society. As our populations continue to age, Alzheimer’s and Parkinson’s may affect more than 50 million people globally. In the USA alone, Alzheimer’s treatments rose to $259 USD billion in 2017. While the demand for CNS drug delivery is evident, there are currently few proven formulations, delivery systems and non-clinical models to evaluate CNS administration.
This webinar will focus on the advantages of nasal powder formulations and on a non-human primate (NHP) model to quantify nose-to-brain delivery of a model compound, sumatriptan. The webinar will also compare pharmacokinetic advantages of nasal powders versus aqueous formulations, as well as in vitro results of nasal powder delivery.
We will also present results from a non-human primates (NHP) cross-over study performed in cynomologus macaques. This study focused on systemic and cerebral spinal fluid (CSF) drug concentrations of sumatriptan administered nasally from a dry powder device, a liquid aerosol device and via subcutaneous delivery. A model was successfully developed to quantify CSF delivery with data that suggests that the NHP model can be used to evaluate nasal delivery as a non-clinical model.
Using the methodology described above, we will demonstrate that a nasal powder increased the extent of absorption in the systemic circulation and CSF. Join us to explore the available opportunities for nasal drug deliveries in CNS medications.
Presented by
Julie D. Suman,
President, Next Breath, an Aptar Pharma business
Julie D. Suman, R.Ph., Ph.D is the Founder of Next Breath, an Aptar Pharma business, and serves as its President. Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). Dr. Suman is co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. She is also a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings at the FDA Topics in Bioequivalence Seminar Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman is also a member of the Parental Drug Association Visible Particulate Taskforce.
Philip Kuehl, PhD,
Senior Scientist, Lovelace Biomedical
Philip Kuehl, Ph.D., is a Senior Scientist and Director of the Scientific Core Laboratories at Lovelace Biomedical. Dr. Kuehl is an expert in formulation by all routes, and is renowned for his contributions to pulmonary formulation and respiratory drug development. He has over 50 publications in drug development, drug delivery and formulation. He is a member of the International Society of Aerosols in Medicine and ad hoc reviewer of numerous journals. Dr. Kuehl received his B.A. in biochemistry from Hamline University in St. Paul, Minnesota and a Ph.D. in pharmaceutical sciences (minor in analytical chemistry) from the University of Arizona. Dr. Kuehl joined Lovelace in 2007.
