Pharmaceutical Semi-Solid Dosage Form

Mukund (Mike) Yelvigi

Khurshid Iqbal, Ph.D.

Course description

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:

• Describe physico-chemical principles of semi-solid formulations
• List the critical project management and regulatory issues of semi-solid dosage forms development
• Describe the scale-up to manufacturing and transfer of technology from R&D to production
• Apply the Quality by Design concepts at R&D and scale-up
• Assess the regulatory issues, equipment selection, cost considerations, and critical need for coordination between R&D, Process Development, Production and Q/A groups
• Develop a pilot process suitable for scale-up to production
• List the factors to consider during scale-up and technology transfer