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.
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
