Recent innovations and enhancements to pharmaceutical spray drying
The text discusses the use of spray drying in the pharmaceutical industry for enhancing particle engineering and bioavailability, with a focus on Lonza's expertise and advancements.
Key points include:
*Spray Drying Process: Continuous and scalable for different stages from early feasibility to large-scale production. Recent improvements have expanded solution composition choices, avoiding environmentally harmful solvents.
*Recent Advancements: Lonza has made significant progress in spray drying, particularly for combination dry powder formulations for lung cancer treatment. They have developed methods for processing poorly soluble molecules into amorphous dispersions to enhance oral bioavailability, using novel solvents and heated solution processing to avoid undesirable solvents like THF and DCM.
*Key Market Drivers: The small molecules drug development pipeline is growing, with more than 75% of new chemical entities (NCEs) facing bioavailability issues. Small biopharmaceuticals often lack the expertise to address these issues.
*Amorphous Solid Dispersions (ASDs): Proven effective in enhancing API solubility and absorption. ASDs place APIs in a higher energy state compared to crystalline forms but present stability risks. Spray drying is a preferred method due to its applicability, ability to accommodate high-dose compounds, and flexibility for various formulations.
*Lonza's Capabilities: Lonza provides integrated services to address solubility challenges, with expertise in spray drying and other technologies. They have multiple sites worldwide and over 25 years of experience.
*Spray Drying Process Control: Key factors include drying kinetics, atomization, solution rheology, and particle size distribution. Lonza's process ensures minimal API degradation by controlling temperature and using stabilizing excipients.
*Scaling and Optimization: Lonza helps clients optimize formulations by evaluating various parameters, ensuring quality and stability through extensive testing.
*Conclusion: Spray drying is essential for enhancing bioavailability through amorphous dispersions. Lonza's advancements allow the use of safer solvents and support development and commercialization from small to large-scale quantities.
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