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Formulation and Stability of Nutraceuticals
Tuesday, November 13
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-516-L04
Nutraceuticals are quickly gaining attention due to increasing consumer market share for wellness products. There has been a heightened focus in the marketing, claims substantiation, manufacturing, and FDA-based regulations of Nutraceuticals. The types of products that could fall under the Nutraceutical Umbrella, while loosely defined under DSHEA, remain broad. Additionally, some medical foods are starting to be marketed by prescription typically to get the patient a reimbursement from insurance companies. The Medical Foods Act passed by congress, requires such foods to be administered under the supervision of a physician. The manufacturing of such products, however, has been largely unregulated and lacks desired quality control systems. It can be argued that the European countries have better regulated such products. The United States FDA has issued a draft for cGMP regulations of dietary supplements, which is overdue for finalization. The potential impact of these pending regulations has already raised concerns within the manufacturing industry, and the delay in the FDA’s issuance of the final regulations is an indication of the volume and breadth of the comments received in response to the proposed regulations. While the Final Rule on Labeling provides some guidance under DSHEA, the manufacturing landscape is about to change even more. Along with these changes, better formulation and testing methods are getting attention. The moderators and invited speakers will have hands-on experience in the arena of analytical testing and formulation enhancement for stability of such products. The potential interactions between ingredients of various dosage forms, avenues explored and successful technology will be discussed. Analytical methods are being developed, or will soon need to be developed, for marker compounds found in herbs, vitamins and minerals with a new focus on rapid, accurate, reliable and efficient quantitation in a complex matrix and separation from other ingredients to discern and possibly detect related compounds of materials never tested this closely before. Various investigations on factors determining stability and enhancement of Nutraceuticals’ shelf life will be discussed.
Moderators
Jai Mehta, Ph.D.
JM Pharma
Robert L. Chapman, Ph.D.
Midwestern University Chicago College of Pharmacy
Formulation Issues Related to Dietary Supplements and Nutraceuticals
Walter G. Chambliss, Ph.D.
University of Mississippi
Formulation of Stable Nutraceuticals
Mary A. Murray, Ph.D.
Access Business Group
Do All the Nutraceuticals on the Market Have Similar Quality?
William Obermeyer, Ph.D.
ConsumerLab