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By: Junshu Zhao, Jian-Xin Li, and Howard Chen

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In modern pharmaceutical dosage form design, excipients play a central role in delivering the drug in a safe and effective manner. How do they achieve that, you might ask? Well, some excipients are in the formulation to ensure the drug is uniformly distributed such that there is minimal variation from dose to dose; some are to ensure a fast breakage of a dosage form so the drug is released for an immediate action; some are to ensure the drug is released over a prolonged duration to ease the patient’s burden on dosing. There are many other examples of what benefits excipients can bring to the dosage form, and very often, these functional excipients are polymers.

In both solid and liquid formulations, natural and synthetic polymers are widely used to provide critical functions for processing and delivery of a drug. Such polymer excipients include but are not limited to binders, disintegrants, modified-release matrices and membranes, stabilizing agents for amorphous dispersions, etc. The special functionalities of this class of materials are results of their unique properties such as viscoelasticity, swelling, and gelling as dictated by the structure of the polymer molecules. These properties can often be influenced by the microenvironment of these excipients in the formulation, adding to the complication in ensuring the proper functionality and product performance (particularly drug release). Underneath the apparently complicated and mysterious behaviors of this class of materials lie the universal principles that govern their structure-property relationships. With the knowledge of these principles, the behavior of polymer excipients can be much better dissected, understood and controlled.

As part of the 2016 AAPS Annual Meeting and Exposition, the short course Fundamentals of Polymer Science and Application in Drug Delivery and Product Development is designed to closely integrate discussions on the fundamentals of polymer science with the applications of the most commonly used polymer excipients to provide scientists a holistic understanding of the polymer structure-property relationships and characterization methodologies for making educated choices on these materials for drug product design and methods for characterization and trouble shooting.

Please join us for a dialogue in this short course on Saturday, November 13, at the Colorado Convention Center prior to the start of the main AAPS Annual Meeting. If you’re not able to make it, please feel free to comment below or contact us (Junshu.Zhao@bms.com, Jian-Xin.Li@ferring.com, howard.chen@nanocopoeia.com) for further discussion.

Howard Chen, Ph.D., is a senior scientist at Nanocopoeia, Inc. which develops particle based therapeutics.  He has more than five years of experience in developing oral, nasal, and injectable drug products.
Junshu Zhao is currently a Senior Research Investigator in Pharmaceutical Development at Bristol-Myers Squibb (BMS) in New Jersey, and the 2017 chair-elect of the AAPS Excipient Focus Group.
Dr. Jian-Xin Li has been well recognized globally for his contributions to Arden Conference. He co-chaired the 41st (2006) and chaired 43rd (2008), 45th (2010), 48th (2013) AAPS Arden Pharmaceutical Technology.