Course Description

Pharmaceutical Non-Sterile Liquid Dosage Form Development, Scale-up & Manufacture

This course is currently at capacity or unavailable for registration, please contact Customer Service at (732)613-4500 or for more information.

Course ID 2730

In-Person Course

Who Should Attend?
The course is designed for individuals who are engaged in the pharmaceutical liquid dosage forms(non-sterile). It is intended for individuals who work in the development of Pharmaceutical Liquid Dosage Forms (Ethical and Over the counter) formulation development including raw materials selection, various liquid drug delivery systems for internal and external applications, formulation scale-up and manufacturing process, application of Quality by Design (QbD) and Process Analytical Technology (PAT) concepts, validation, clinical supply manufacture and quality testing. Personnel in the following functions will benefit:

  • R&D scientist/technicians/Analytical chemists/CMC personnel
  • Manufacturing supervisors/ operators/technicians/engineers/managers
  • Pilot Plant Operation and Scale-Up
  • Regulatory Affairs/Quality Control/Technology transfer personnel
  • Project Managers/Business Development?

Course Description
This 2-day intensive course is designed to provide a set of theoretical and practical tools for those interested in working with non-sterile pharmaceutical Liquid formulation development either for prescription or OTC drugs such as cough syrups, elixirs, expectorants, mouth washes, irrigation fluids for external use, nasal inhalation solutions, ear drops, eye drops, rectal preparations (Enemas), emulsions, creams, gels and solutions. The participant will learn how to determine and evaluate the criteria for the selection of right raw materials and manufacturing processes needed to create stable liquid Dosage Forms products, and to effectively solve problems arising during development. Troubleshooting existing commercial product problems will be emphasized. The theoretical underpinnings of various types of liquid aqueous, organic, micellar and suspension behavior will be described to provide a backdrop for discussions of specific emulsifying and suspending systems. Current methods to analyze the behavior of dispersed phases will be described, as will methods to measure and predict stability of the products. Processing and scale-up issues specific to the type of equipment needed to create uniform, homogenous liquids, dispersed phases will also be discussed. Key emphasis will be placed on application of recent (QbD) principles and (PAT) in the formulation, development and scale up. Risk analysis tools will be discussed along with key principles of process validation, technology transfers and clinical manufacturing.

Course Director
Mukund “Mike” Yelvigi; Principal and Managing Partner, Center for Pharmaceutical Integration, LLC. New Jersey

Mike Yelvigi is Principal and Managing Partner at Center for Pharmaceutical Integration LLC, which provides consultation service to the industry in the area of CMC support &Technology Integration and Transfers (mergers & acquisitions). He retired as Sr. Director and Head of CMC Therapeutic Area Management function at Pfizer/Wyeth Inc. NY. He had responsibility for co-ordination of CMC activities related to drug substance synthesis, drug product formulation, analytical development and regulatory filing for several therapeutic areas. He has over thirty years extensive experience in pharmaceutical formulation, process development/scale-up, process validation, manufacturing and pre-approval inspections and has successfully launched several products globally. Earlier to this, he was Head of Process Development and clinical supply group at Hoffman-La Roche Company, New Jersey. Other companies he has worked include Parke Davis (USA), G.D Searle and Organon Inc. He obtained his undergraduate degree in Pharmacy from Bombay University and graduate degree in Pharmacy, from Philadelphia College of Pharmacy.

He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi. He is an active member of AAPS, ISPE, AAiPS, FIP and has lectured at many symposiums in the pharmaceutical technology, drug development areas. He was the Chairperson of the AAPS Manufacturing Science & Engineering section and is also an Executive committee member of the Industrial Pharmacy Section of FIP. He is a editorial board member of Pharma Times journal.

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Course Director
Khurshid Iqbal, Ph.D.; Pharmaceutical & Biotechnology Consultant and Advisor

Dr. Iqbal has over 25 + years of domestic and international experience in pharmaceutical product development. He has worked within the leading multinational pharmaceutical organizations, R.W. Johnson Pharmaceutical Research Institute, Hoffmann-La Roche and E.R. Squibb & Sons and last as Sr. Vice President and CSO at KBI Biopharma, Inc. Dr. Iqbal earned his Ph.D. in Pharmaceutics from The University of Sciences, Philadelphia and has remained active in the field of biopharmaceutical formulation development, drug delivery and stabilization of proteins and peptides. Dr. Iqbal has published consistently in this field and has extensive experience in formulations products, drug delivery and product development of a variety of dosage forms, including sterile products, topicals, emulsions and suspensions . He was responsible for filing several INDs, NDAs and PLAs during his career with big pharma. He was elected as the section chair of the Biotech section of The American Association of Pharmaceutical Scientists, (AAPS) in 1992 and has remained active with the growth of this organization.

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