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With continued advancements in pharmaceutical innovation, there is increasing demand for excipients that can support lyophilized formulations and enable long-term stability of sensitive therapeutics, as traditional lyoprotectants do not always provide sufficient protection during freezing and drying stresses, especially for proteins, peptides and nucleic acid-based products. Cyclodextrins present a distinctive opportunity as multifunctional excipients that can serve as both stabilizers and lyoprotectants, helping preserve product integrity during lyophilization while potentially simplifying formulations and improving reconstitution performance.
In addition, poor aqueous solubility of active pharmaceutical ingredients (APIs) remains a principal barrier to developing successful injectable drug products. Another key challenge is maintaining the physical and chemical stability of both small-molecule drugs and biologics throughout manufacturing, storage and administration. As the pharmaceutical industry continues to evolve, there is a growing opportunity for advanced cyclodextrin-based solutions for injectable and high-concentration products that provide improved solubilization while maintaining acceptable safety and regulatory profiles, as well as offering opportunities to improve stability by shielding sensitive regions of drug molecules, reducing degradation pathways and enhancing compatibility with challenging formulations.
This webinar aims to review the cyclodextrin types relevant to parenteral administration for lyophilized formulations, the physicochemical properties that govern their use, solubility, osmolality, viscosity, filterability and the safety and regulatory framework. A rational, step-by-step formulation approach will then be presented, including touchpoints on phase solubility isotherms, cyclodextrin selection, excipient screening and formulation assembly, and applied to marketed injectable product examples. The session will conclude with practical guidance for applying this methodology to low-solubility compounds in development, as well as a live Q&A session with our experts.
This hourlong session will highlight practical insights into:
Register for the webinar today to learn about the innovative ways in which cyclodextrins are being used in advanced pharmaceutical formulation and delivery.
presenter information:
Niloofar Heshmati, PhD
senior staff scientist
Ashland
Niloofar is a senior staff scientist at Ashland, specializing in pharmaceutical formulation and advanced drug delivery systems. She holds a PhD in Materials Science, Engineering, and Commercialization and has extensive experience in the development and characterization of complex injectable formulations. Her work focuses on formulation development, drug delivery, and the application of functional excipients to improve drug solubility, stability, and performance. Niloofar can be contacted at Niloofar.Heshmati@ashland.com
Natália Marchesan Bexiga, PhD
bionanomanufacturing center doctoral researcher
Institute for Technological Research (IPT)
Natália holds a Bachelor's degree in Pharmaceutical Sciences, as well as a Master's degree, PhD and postdoctoral training in Biochemical-Pharmaceutical Technology from the University of São Paulo. Her expertise encompasses nanotechnology, synthetic biology and lyophilization. She has over ten years of experience in the development of lyophilized formulations and lyophilization cycles, including scale-up and technology transfer of lyophilization processes, as well as lyophilizer performance qualification. She also has extensive expertise in pre-formulation studies, including Differential Scanning Calorimetry (DSC) and Freeze-Drying Microscopy (FDM) for determining the critical temperatures of lyophilization formulations. In addition, she is highly experienced in post-lyophilization characterization techniques used to evaluate the critical quality attributes of lyophilized products, including solid-state NMR (ssNMR), FTIR spectroscopy, Karl Fischer titration, DSC and X-ray diffraction (XRD). As part of her doctoral training, Dr. Natália conducted research at the Johns Hopkins Bloomberg School of Public Health, where she gained international experience in nanotechnology and lyophilization. She is currently a doctoral researcher at the Bionanomanufacturing Center of the Institute for Technological Research (IPT), Brazil, and serves as a consultant specializing in pharmaceutical lyophilization. Her consulting activities include the development of lyophilization formulations, thermal characterization of formulations, design and optimization of lyophilization cycles and scale-up and technology transfer for pharmaceutical, veterinary and biotechnology companies, as well as compounding pharmacies. She also provides both theoretical and hands-on training in the lyophilization of pharmaceutical products. Natália can be contacted at natalia@lyotracker.com
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