Case Study – Solubility Enhancement was Mission Critical for Nasal Epilepsy Treatment
What’s In This Case Study
Drugs used for seizure management should have a rapid onset of action, and have quick, easy, and convenient administration routes, including a self-administration option. Existing therapies have drawbacks; Neurelis, a biotechnology company specializing in neuroscience, turned to Lubrizol Life Science Health (LLS Health) to address these challenges during the development of the company’s lead product, VALTOCO® (diazepam nasal spray).
The solution-based formulation had to be optimized to ensure adequate solubility and bioavailability in a non-irritating vehicle, while also achieving a suitable shelf-life at controlled room temperature (CRT). Neurelis also needed to develop a novel formulation that could be protected while avoiding the use of other intellectual property (IP). Therefore, effective solubilization technology and expertise, as well as IP knowledge was essential.