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Catalent & Evonik’s Hot Melt Extrusion Workshop

Date: Thursday, March 12, 2020
Time: 8:30am- 3:00pm
Location: 14 Schoolhouse Road, Somerset, NJ 08873

Register to attend this free event.

Catalent and Evonik Industries are excited to announce a joint workshop titled, “A Deep Dive into the Technologies for Advanced Formulation and Targeted Delivery.”

Topics will include:

  • Hot melt extrusion solid dispersion formulations and process development
  • Hot melt extrusion for bioavailability enhancement and scale-up
  • Formulation and scale-up strategies for controlled-release oral solid dosage forms

Followed by a lab demonstration and tour of Catalent’s Somerset facility.

AGENDA

TIME

TOPIC

SPEAKER

8:30 am – 8:45 am
Arrival & refreshments
8:45 am – 09:00 am
Welcome Address
Catalent & Evonik

Marlene Leuenberger
General Manager
Catalent Somerset

09:00 am – 09:50 am
A Structured Approach for Hot Melt Extrusion Solid Dispersion Formulations and Process Development

Dr. Firouz Asgarzadeh
Director
Formulation & Application Services
Evonik

09:50 am – 10:40 am
Strategies for Controlled-Release Oral Solid Dosage Forms

  • Matching in vivo needs
  • Overview of CR approaches
  • Tablet film coating
  • Multi-particulate coating using fluid bed

Ronald Vladyka, R.Ph
Director
Formulation Research & Product Development
Catalent

10:50 am – 12:15 pm
Lab Demo
Leistritz 27 mm HME extruder, GPCG 30 18” wurster column, O’Hare coating pan
12:15 pm – 1:15 pm
Networking Lunch

1:15 pm – 2:00 pm

Hot Melt Extrusion in Development of Microenvironment Responsive Abuse Deterrent Formulation: Case Study

Ketan Patel
Assistant Professor
St. John’s University

2:00 pm – 2:45 pm

HME for Bioavailability Enhancement & Beyond

  • Amorphous solid dispersions to overcome poorly solubility
  • CR formulations using HME
  • Using polymer screening data to set critical process parameters
  • HME scale-up

Sampada Upadhye, PhD
Study Director
Bioavailability Enhancement
Catalent

2:45 pm – 3:00 pm
Closing Remarks
3:00 pm – 4:00 pm (optional)
Meet the speakers/1:1 consultancy

BIOS

Firouz Asgarzadeh, Ph.D., is Director of Technical Marketing at Evonik Industries, supporting the Eudragit® modified-delivery product line.  Dr. Asgarzadeh has over 20 years’ experience in the development of solid, liquid and injectable pharmaceutical formulations.  His current focus at Evonik is the development of innovative formulations and processes for targeted oral drug delivery, injectable extended-release, and solubility and bioavailability enhancement of poorly soluble actives. Dr. Asgarzadeh earned his doctorate in Polymeric Materials and Composites from Université Claude Bernard (Lyon), France.  He holds a master’s in physical chemistry of molecular and macromolecular materials from the Université Louis Pasteur (Strasbourg), France and in polymer engineering from the Polytechnic University, Tehran, Iran.

Ronald Vladyka, R.Ph., is Director of Product Development, Formulation Analytical Research & Development at Catalent.  Mr. Vladyka has over 30 years of industry experience in various Product and drug delivery development roles.  His areas of interest include the development of enabling drug delivery technologies and the design and development of formulations for modified-release dosage forms.  He holds over 12 U.S. patents and has authored and contributed to numerous research articles.  Mr. Vladyka received his bachelor’s degree in biology from Lebanon Valley College and a bachelor’s in Pharmacy from Arnold and Marie Schwartz College of Pharmacy, Long Island University.

Ketan Patel, Ph.D., is an Assistant Professor, Industrial Pharmacy at St. John’s University where his research laboratory focuses on the development of melanoma and pancreatic cancer-targeted nanoparticles, self-emulsifying systems, hot melt extrusion, abuse deterrent formulations, and vaginal films for HIV prevention.  He has published over 40 research papers and three U.S. patents in the areas of cancer nanomedicine, oral and vaginal nano-formulations, 3D printing and abuse deterrent formulations. Dr. Patel received his doctorate in pharmaceutics from UDCT in Mumbai, India and completed his post-doctoral fellowship at Florida A&M University.

Sampada Upadhye, Ph.D., is Global Study Director, Hot Melt Extrusion Technology at Catalent.  She is responsible for strategic and scientific execution of all HME bioavailability enhancement projects, ranging from early-phase development to commercial supply.  Dr. Upadhye has extensive experience in solubilization or pre-clinical new chemical entities, and formulation design of amorphous solid dispersion technologies for hot melt extrusion and spray drying.  She has several patents and peer-reviewed publications, including contributing chapters to: Melt Extrusion: Materials, Technology and Drug Product Design (edited by MA Repka, et. al.) and Contemporary Research Topics in Pharmaceutical Excipients (edited by Ajit Narang, et. al.).  Dr. Upadhye received her doctorate from The University of Mississippi.