Sponsored Content

Formulation Challenges in Lyophilized Products

Telstar-2

Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of thermolabile and biopharmaceutical products, requiring a deep understanding of physicochemical processes and drug-excipient interactions. Freeze-drying is a widely used method to stabilize sensitive APIs such as pantoprazole sodium sesquihydrate, which presents cosmetic defects like cake cracking despite its chemical stability. This study, conducted by the Syntegon Telstar Process Laboratory, aimed to mitigate cracking through optimized formulation strategies using mannitol and trehalose in different ratios and processing conditions. Thermal analysis (DSC, FDM), crystallinity assessment (PXRD), and product characterization revealed that a 3:1 mannitol-to-trehalose ratio at 10% solid content with -10 °C annealing produced the most stable and visually acceptable formulation. This matrix favored- -mannitol crystallization and preserved trehalose in its amorphous state, minimizing polymorphic instability and improving cake structure. The findings underscore the importance of excipient selection and process design in achieving high-quality lyophilized pharmaceutical products.


About Telstar 

Telstar, part of Syntegon, is specialized in the development of GMP consultancy, engineering & construction projects and integrated process equipment, for companies associated with Life & Health Sciences (pharmaceutical & biotechnology, healthcare, cosmetic, veterinary and food & beverage industries, hospitals, laboratories & research centers). Acknowledged as one of the 10 major suppliers for the pharmaceutical industry, Telstar is one of the few international brands able to offer integrated process solutions for the biopharmaceutical industry with in-house sterilization, freeze drying, clean air and cold storage technologies.

Download Sponsored Content


To download this sponsored content, complete the form below. Once submitted, you will receive a link via the email you provided to download the sponsored content.

Name
Company Type
Address

By completing this form, you consent to have your information provided to the third-party sponsor of this content and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you . ISPE will store your information in a secure environment and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you. You may unsubscribe from these ISPE communications at any time. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.