This webinar will focus on the challenges isolated populations have faced during the global pandemic related to patient adherence, and the application of formulation strategies to create more patient centric solutions.  The webinar will include several panel speakers representing different perspectives including:

Regulatory:

  • FDA expectations for safety studies for novel excipients
  • Complexities and challenges for analytical methods for flavorants
  • Quality attributes for chewable tablets

Excipients Quality Related to Dose Forms:

  • Minitablets for the improvement of patient compliance
  • How do excipients impact the quality of minitablets
  • Taste masking of minitablets and the evaluation of taste masking effectiveness in soft food

Challenges Regarding Patience Adherence and Formulation Strategies:

  • Details and mechanisms associated with swallowing
  • Current gaps with oral solutions for pediatrics, geriatrics and dysphagic patients 
  • Formulation technologies related to taste masking and novel dose forms providing patient centric solutions

Featured Speakers

Luigi Boltri

Senior Director, Technology Development
Adare Pharmaceuticals

Dr. Boltri is a pharmaceutical chemist by training and completed his degree at the University of Turin, with almost 30 years of experience in the Pharmaceutical Industry, Dr Boltri has held leading positions as Department Head and Director.

Dr. Boltri has extensive experience in formulation development for various dosage forms, with a focus on oral delivery and bioavailability enhancement.

15 original/innovative products developed from prototype profiling to commercial scale.

In his current role, Dr. Boltri identifies new and innovative technologies as well as valuable opportunities for product development and co-development.

George Reid

Principal Consultant
Cardinal Health

George Reid, principal consultant with Cardinal Health Regulatory Sciences, has more than 25 years of human and veterinary CMC technical and regulatory experience.  He has contributed to several approved medicines and currently works with clients focusing on analytical and formulation sciences from preclinical to post-approval.

George received a doctorate in chemistry from Missouri University of Science and Technology and a B.S. in Biochemistry from Beloit College.  He has publications and presentations in pharmaceutical analysis, and most recently was co-editor of a book on Specifications of Drug Substances and Products.

Vivian Bi

Director of Global Pharmaceutical R&D and North America Technical Service
Ashland Specialty Ingredient (ASI)

Dr. Vivian Bi is a Director of Global Pharmaceutical R&D and North America Technical Service at Ashland Specialty Ingredient (ASI). She has held various positions in Pfizer Global R&D, Vertex Pharmaceuticals and AstraZeneca Pharmaceuticals before joining ASI. Her research interests are oral and parenteral drug delivery systems. Dr. Bi has published over 50 research papers, abstracts and patents.  She also serves as a reviewer for research journals such as Pharmaceutical Research and Journal of Pharmaceutical Sciences.  Dr. Bi obtained her B.S. degree from Shenyang Pharmaceutical University in China, and completed her Ph.D. in Pharmaceutical Science from Meijo University in Japan.

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