Spray drying is a continuous, reproducible, cost-effective, and scalable process to produce dry powders from a liquid solution or suspension by rapidly drying with a hot gas. The main reason for its growth in the pharmaceutical industry in the recent years has been the formulation of amorphous solid dispersions for oral drugs to increase the solubility and bioavailability of poorly soluble compounds. Apart from this, Spray Drying is a well-suited technology to produce, not only solid dispersions, but it is also widely used in the field of microencapsulation, nanotechnology, drug combination, proteins, probiotics, inhalation powders, vaccines and, even, feasible organisms.
The use of the Quality by Design (QbD) methodology allows the product and process understanding and facilitates the development of the spray drying process in an efficient and cost-effective way. This approach is employed to identify, from early stages, the risks related to the formulation and manufacturing process that can potentially impact product quality and, consequently, helps to guide studies to mitigate such risks. Adopting a QbD methodology from the initial development for first clinical trials is highly recommended for a more robust process for the remaining stages of the clinical program.
The implementation of this systematic approach based on sound science and quality risk management principles, through tools like Design of Experiments (DoE), allows a deeper knowledge of the product and manufacturing processes, minimizing risks and saving time and resources.
In this webinar, we will provide useful guidelines and tips for a QbD approach in Spray Drying processes, highlighting the key variables to consider and explaining its application with a case study.