For both prescription and OTC pharmaceuticals, a semi-solid dosage form is a very common delivery method for the drug product. But just because they are common does not mean that they are easy to develop and manufacture. In fact, there are a whole host of issues that can arise during development and manufacture that can result in marginal or unacceptable product.
This intensive course will provide a set of theoretical and practical tools for pharmaceutical semi-solid formulation development either for prescription or OTC drugs. The selection of the correct raw materials and manufacturing processes needed to create stable semi-solid dispersed-phase products and to effectively solve problems arising during development will be addressed.
Troubleshooting existing commercial product problems will be emphasized. Emulsion and suspension behavior will be described along with current methods to analyze the behavior of dispersed phases and methods to measure and predict stability. Processing and scaleup issues specific to the type of equipment will be covered. Key emphasis will be placed on application of Quality by Design (QbD) principles and Process Analytical Technology (PAT). Risk analysis tools, key principles of process validation, technology transfers, and clinical manufacturing will be discussed. Chemical engineering aspects of Unit Operations will likewise be addressed.
Upon completion of this course, you will be able to:
You will be redirected to our secure system.
The course is designed for professionals engaged in the pharmaceutical Semi-Solid dosage forms. It is intended for professionals who work in formulation development, raw materials selection, drug delivery systems, scale-up and manufacturing process, validation, clinical supply manufacture and quality testing.
Such personnel include:
Mukund (Mike) Yelvigi
Principal and Managing Partner, Center for Pharmaceutical Integration, LLC
Mukund (Mike) Yelvigi’s CoursesKhurshid Iqbal, Ph.D.
Pharmaceutical & Biotechnology Consultant and Advisor
Khurshid Iqbal, Ph.D.’s CoursesWhen you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn more