Application of lyophilization in pharmaceutical injectable formulations: An industry and regulatory perspective

• Published in: Journal of drug delivery science and technology 2024-10, Vol.100, p.106089, Article 106089
• Main Authors: Kumar, Samarth, Sanap, Sachin N., Vasoya, Milan, Handa, Mayank, Pandey, Prachi, Khopade, Ajay, Sawant, Krutika K.
• Format: Article
• Language: English
• Subjects: Excipient; Industry; Injectable; Lyophilization; Quality by design; Regulatory
• ISSN: 1773-2247
• DOI: 10.1016/j.jddst.2024.106089

The process of lyophilization plays a crucial part in the manufacturing of pharmaceutical, biotechnology, and food industries products by enabling the production of stable medication formulations that would otherwise be unstable in their easy-to-use state. Specific formulations may necessitate using some excipients, which maintain the visual quality of the product and ensure its stability over an extended period. The optimization of lyophilization parameters and process, specifically during the freezing and drying stages, holds significance due to their potential influence on process efficiency and product performance. This paper offers the reader a comprehensive examination of the lyophilization process, encompassing various essential factors and elements of product development, including formulation considerations, process optimization, common causes and possible solutions, and QbD application in lyophilization. Furthermore, we have discussed manufacturing processes, including compounding, filtration, filling, lyophilization product defects, various techniques used to characterize these products, application of lyophilization in pharmaceutical and biotechnological formulation, and case studies of lyophilized products that are recalled from the market to help the formulation scientist. Overall, it will help readers thoroughly comprehend the lyophilization process, application, challenges and possible solutions from both industry and regulatory perspectives. [Display omitted]