Development of topical semi-solid products and significance of Critical Process Parameters (CPP) studies
Sponsored by: CPL
- Critical Process Parameters
- Topical Drug Products
Date: 10 June
Time: 3PM London/10AM New York
Many semi-solid, topical dosage forms are multi-phasic formulations having complex structural elements. Interaction between the phases, size of the dispersed particles/globules, the partition coefficient of the active ingredient between the phases, and the product rheology determines the final product release characteristics. With product complexity comes potential risk of failure during manufacturing scale-up unless Critical Process Parameters are carefully considered.
Critical process parameters such as range of temperature during manufacturing process (heating and cooling), mixing methods and speeds, homogenization, pressure, and kettle geometry can significantly affect the product characteristics and quality. Other factors including filling and packaging activities can have a significant contribution in determining the product quality and performance as well.
Therefore, systematic product development and thorough understanding of Critical Process Parameters are very important considerations for successful topical product manufacturing. This webinar will focus on how Critical Process Parameters are utilized to ensure successful formulation and scale-up of topical drug products and the importance of integrating them into topical product development.
Manager, Formulation Development
Chetan Chure is Manager, Formulation Development at Contract Pharmaceuticals Limited (CPL) in Mississauga, Ontario and has spent 13 years in the research and development of semi-solid (topical) dosage forms for pharmaceutical products. Chetan holds a Master’s degree in Pharmaceutical Sciences from Birla Institute of Technology & Science, India (BITS-Pilani). Prior to CPL, Chetan worked for Zydus Pharmaceuticals, Glenmark Pharmaceuticals and other pharmaceutical companies. He has authored patents and published several research articles. His primary area of interest is semi-solid (topical) dosage form development and scale-up activity. He has been extensively involved with the development and optimization of many successful ANDA products throughout his career.
Key Learning Objectives
- Systematic formulation development of topical drug products from scalability perspective
- Understand how Critical Process Parameters can be used to develop topical products
- Learn how to avoid potential product failure during formulation and development process using CPPs
- VP - Director - Manager - Head - Leader of:
- Research and Development
- Product Development
- Formulation Development
- Technical Operations
- Quality Control
- Dermatology Products/Drugs