Webinar: transforming your crystallization process
Nandi, S. et al. Continuous Microfluidic Antisolvent Crystallization as a Bottom-Up Solution for the Development of Long-Acting Injectable Formulations. Pharmaceutics 2024, 16, 376. https://doi.org/10.3390/pharmaceutics16030376
A bottom-up approach was investigated to produce long-acting injectable (LAI) suspension-based formulations to overcome specific limitations of top-down manufacturing methods by tailoring drug characteristics while making the methods more sustainable and cost-efficient. A Secoya microfluidic crystallization technology-based continuous liquid antisolvent crystallization (SCT-CLASC) process was optimized and afterwards compared to an earlier developed microchannel reactor-based continuous liquid antisolvent crystallization (MCR-CLASC) setup, using itraconazole (ITZ) as the model drug. After operating parameter optimization and downstream processing (i.e., concentrating the suspensions), stable micro suspensions were generated with a final solid loading of 300 mg ITZ/g suspension. The optimized post-precipitation feed suspension consisted of 40 mg ITZ/g suspension with a drug-to-excipient ratio of 53:1. Compared to the MCR-CLASC setup, where the post-precipitation feed suspensions contained 10 mg ITZ/g suspension and had a drug-to-excipient ratio of 2:1, a higher drug concentration and lower excipient use were successfully achieved to produce LAI microsuspensions using the SCT-CLASC setup. To ensure stability during drug crystallization and storage, the suspensions’ quality was monitored for particle size distribution (PSD), solid-state form, and particle morphology. The PSD of the ITZ crystals in suspension was maintained within the target range of 1–10 m, while the crystals displayed an elongated plate-shaped morphology and the solid state was confirmed to be form I, which is the most thermodynamically stable form of ITZ. In conclusion, this work lays the foundation for the SCT-CLASC process as an energy-efficient, robust, and reproducible bottom-up approach for the manufacture of LAI microsuspensions using ITZ at an industrial scale.
Secoya Technologies has confirmed its participation in the upcoming Formulation and Delivery Congress set to be held in London from April 26th to April 28th.
Meet Diala Youssevitch, Adrien Dewandre and Bart Rimez to discover our latest API encapsulation and crystallization improvements.
About Formulation and Delivery
Formulation & Delivery 2024 aims to connect pharmaceutical & biotech representatives as well as academia for high-level discussions on the latest innovations in pharmaceutical drugs formulation, drug delivery, inhaled therapeutics & RNA development.
This momentous achievement allows Secoya Technologies to explore and expand into new markets.
3/02/2020
Dr. Bart Rimez, co-founder and Crystallization Technology Lead, was invited to publish in the Emerging Scientists issue of Journal of Flow Chemistry, coming out beginning 2020. The paper deals with our findings on the synergistic effect of nucleation thermodynamics and hydrodynamics to increase nucleation rate. Read more