XtraReg160x1608
Short Course 1: Pharmaceutical Excipients—Biopharmaceutical, QC and Regulatory Considerations

Short Course

8:30 AM–4:00 PM Nov 12, 2017

San Diego Convention Center - Room 23AB

Description

Moderators:

  • Jasmine Musakhanian
  • Sherin Thomas M.S.

Proposal Description:

An additional fee is required to attend this short course. To register, visit www.aaps.org/AMRegister

An unending list of diverse and versatile excipients is available to pharmaceutical scientists who are involved with dosage form design and drug product development. These excipients are either small molecules or macromolecules, and in order to be qualified for use in drug products, at least in the U.S., they must meet the United States Pharmacopeia-National Formulary (USP-NF) compendial status. In recent years, we have seen an evolution in the use of excipients in drug products that go well beyond their traditional use as formulation and manufacturing aids to include excipient effects on biological barriers such as mucosal membranes and metabolic enzymes. New uses of an excipient permitted for use in a regulated drug product in the U.S. or the development of novel excipients are driven by scientific and business decisions to address unmet medical needs, including the essential need for excipients in drug products, patent protection, and revenues. Regardless of the intended use, the presence of reactive impurities in a given excipient is critical to its qualification and performance in the formulation of both small molecule and biologic drugs. These reactive impurities can lead to drug degradation either directly or indirectly. On the other hand, excipients can stabilize small molecule or biologic drugs via complex formation and other noncovalent drug-excipient interactions. It is apparent from these facts that quality control of pharmaceutical excipients in reference to test methods and specifications as well as quality-by-design aspects in drug products along with regulatory input and guidance are essential elements to their performance optimization. This can be accomplished through a constructive dialogue and collaboration between the key stakeholders in pharmaceutical excipients, including excipient vendors, end users in the biotech and pharma industry, pharmacopeia and regulatory agencies, as well as excipient advocacy groups. This short course’s objective is for expert faculty from the pharmaceutical industry, USP, and Food and Drug Association to address the aforementioned areas and guide pharmaceutical scientists in their dosage form design and drug product optimization efforts.

Learning Objectives:
•Assess traditional and non-traditional uses of excipients in drug products and regulatory implications
•Understand drug-excipient interactions for both small molecules and biologics and impact on drug product quality and performance
•Learn of the challenges and opportunities in updating USP-NF excipient monographs
•Interact with excipient vendors, end users, USP, FDA and excipient advocacy groups

Sub-Sessions
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Short Course

Beverage Break

10:00 AM–10:45 AM Nov 12, 2017

San Diego Convention Center - Room 23AB

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Short Course

Quality-by-Design (Qbd) Aspects

11:30 AM–12:15 PM Nov 12, 2017

San Diego Convention Center - Room 23AB

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Short Course

Buffet Lunch (Short Course Attendees only)

12:15 PM–1:00 PM Nov 12, 2017

San Diego Convention Center - Room 23AB

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Short Course

Beverage Break

2:30 PM–3:15 PM Nov 12, 2017

San Diego Convention Center - Room 23AB

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Short Course

Roundtable Discussion

3:15 PM–4:00 PM Nov 12, 2017

San Diego Convention Center - Room 23AB

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