Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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30 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Lyophilization M any drug products that are unstable in the presence of water are lyophilized to increase stability and shelf life. Lyophilization is a process of preservation by remov- ing water from the product to sufficiently low levels for adequate stability. This stability is achieved by limiting the potential for degradation upon storage caused by hydrolysis reactions with any remaining residual water, referred to as residual moisture. Residual moisture—considered a critical quality attribute (CQA)—can have a significant impact on the stability of a lyophilized product when stored in the dried state. The remaining water at the end of the process can be involved in hydrolysis reactions, which typically lead to degradation. The interaction of residual moisture, or more specifically of avail- able water, on the lyophilized material can result in changes including degradation, crystallization, and collapse. Reconstitution of the drug product can also be affected. Residual moisture testing, therefore, re- quires a method that provides accuracy and precision to low levels. Different methods can be employed to measure residual moisture content in lyophilized materials. Understanding the advantages and suitability of each method and its respective limitations aids in se- lecting the most appropriate method for testing. This paper reviews the common methods for residual moisture testing: loss on drying, thermogravimetric analysis, Karl Fischer coulometric titration, and near infrared (NIR) spectroscopy. The significance of residual water Lyophilization is a way to preserve products that are unstable in the presence of water. Removing the water from the product decreases Residual Moisture Testing Methods for Lyophilized Drug Products Amy M. Bosch and Edward H. Trappler Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials—and the respective limitations— aids in selecting the most appropriate method for testing. Amy M. Bosch is Scientist I at Lyophilization Technology, and Edward H. Trappler is president and founder of Lyophilization Technology. PRO STOCK PROFESSIONAL /SHUTTERSTOCK.COM

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