Webinar:

Optimizing API Bioavailability and Performance using Particle Size Reduction Technologies

Sponsored by: Catalent

Focused on:

  • Particle
  • Size
  • Reduction
  • Formulation
  • Development

Date: 21 April

1675

Time: 4PM London/11AM New York

cGMP Mechanical Milling and Micronization Manufacturing and Analytical Services for Preclinical to Commercial Formulation Development

Particle Size Reduction is a critical manufacturing process for developing various types of dosage forms for small molecules. It’s beneficial in improving API content uniformity for commercial tablet manufacturing, suspension stability and/or feel of oral, topical, or ocular formulations, and is still a conventional technology for enhancing the oral and pulmonary bioavailability of small molecules.

There has been a lot of interest in the recent years for technologies to improve the bioavailability of BCS II and IV compounds due to many promising compounds in the pipeline being challenged by poor solubility. In addition, with advances in COPD (chronic obstructive pulmonary disease), asthma, and inhalation device research and technologies, a tight API particle size distribution is a critical quality attribute for optimizing the pulmonary bioavailability.

This webinar will go over utilization of particle size reduction for improving the bioavailability and performance of small molecules for quick and easy formulation development for pre-clinical, clinical, and final dosage forms.

Join this webinar to hear from experts on cGMP particle size reduction and analytical services on how to expedite your small molecule drug development from preclinical to commercialization for NDA and ANDA compounds.

Presented by

Chris Karayiannis,

Project Manager, Catalent Micron Technologies

Chris Karayiannis is responsible for the Catalent Micron Technologies Project management group at the Dartford UK site. He has over 20 years of micronisation and milling experience leading projects through early stage development, validation lifecycles and into commercial launch.

Elanor Pinto, Ph.D.,

Technical Project Manager, Catalent Micron Technologies

Elanor Pinto, Ph.D. is a Technical Project Manager at Catalent Micron Technologies and the technical lead in Quality-by-Design services to optimize and validate commercial manufacturing using particle reduction cGMP services. Previously, Elanor was a Sr Staff Scientist at Ashland and consulted on pharmaceutical formulation development with cellulosics and poly-vinyl polymers and its derivatives.

Key Learning Objectives

  • Learn the benefits of using milling and micronization cGMP services for enhancing the oral and pulmonary bioavailability of small molecule compounds
  • Learn from the experts on utilizing particle size reduction and analytical services in cGMP formulation development for clinical studies and commercialization

Audience

  • Heads of Research and Development
  • CMC (Chemistry/Manufacturing/Control)
  • Clinical Research
  • Formulation Development
  • Operations
  • Marketing/Product Management
  • Procurement
  • Outsourcing/3rd Party
  • Chief Scientific Officers
  • Chief Executive Officers