As part of its new Early Clinical Formulation Service for APIs, @SEQENS has developed Extrusion Capabilities for Pharma Applications.
💊 40% of marketed drugs and 90% of drugs candidates in the development pipeline are poorly water soluble.
👉 Hot melt extrusion (HME) has been a well-known technology in the food and polymer industries for decades. However, its use in the pharmaceutical industry is much more recent. One of its applications is the production of amorphous solid dispersion (ASD) that are used to solve bioavailability challenges of APIs.
HME key advantages are :
✅ HME is solvent-free, leading to improved environmental impact compared to spray drying approach.
✅ HME is a continuous process that can be easily scaled up for commercial production
✅ The extruded product can be directly formulated as granulates or tablets, thus simplifying the production process while giving the flexibility to develop pediatric and geriatric dosage forms
✅ Vertical HME technique offers high mixing capability and temperature control with reduced contamination risks (thanks to gravitation).
💡The produced ASD will exhibit improved solubility performance over the crystalline form. Furthermore, the polymer matrix in the HME product stabilizes the amorphous form and prevents its conversion to crystalline form.
🎯HME is a key technology for amorphous solid dispersion formulation.
At SEQENS, we are equipped with HME in France and in the US hanks to our collaboration with Rondol Group.
We have the capabilities, scientific and regulatory expertise to provide high-quality services to our customers and improve bioavailability of their API using this innovative technology.
✉️ You want to know more? Please contact: cro@seqens.com
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