Serán Continues to Expand Capabilities

Novel small molecule drugs under development are becoming increasingly challenging to successfully deliver orally due to myriad reasons.  Challenging molecular properties include increasing molecular complexity, poor solubility, and deficient permeability that limit bioavailability when administered orally.  Evaluation of several advanced formulation technologies improves the odds of successful product development.  Serán's top priority when investing in new capabilities is to increase our customers’ product development success rate. To meet our customers’ evolving manufacturing needs, Serán is focused on adding the right technologies at the right time. 

In addition to our wide range of technology solutions for poorly soluble compounds, Serán has added a Leistritz ZSE 18 HP-PH Twin Screw Extruder for hot melt extrusion (HME) and granulation. The modular design includes 16 mm and 18 mm configurations for HME as well as an additional configuration for continuous twin screw wet granulation (TSWG) and twin-screw melt granulation (TSMG). 

HME combines API with a polymer to form a solid dispersion under controlled temperature, pressure, and shear conditions that is then extruded through a die. The extrudate is then quench-cooled using chilled-rolls and milled into a powder, typically using a hammer mill such as Seran’s Quadro SLS Fitzmill. The process makes HME an efficient and scalable technology that provides a solvent-free alternative to spray drying.  

As we move towards reducing our carbon footprint and providing sustainable solutions for pharmaceuticals, we encourage consideration of HME as an alternative technology early on in formulation and technology selection. 

• Molecularly disperse poorly soluble class II and IV drugs, increasing dissolution rates and bioavailability 
• Enhanced solubility and bioavailability for poorly soluble drugs 
• Solvent-free, continuous processing  
• Flexibility in resulting characteristics allowing for a variety of dosage forms 
• Pilot development to Phase III and commercial readiness  

In Summary 

The use of HME technologies is just an example of the many tools Serán utilizes when developing our customer's most challenging compounds. Serán’s approach begins with a comprehensive review of the molecular properties of the drug and the client’s development goals to identify the preferred technical and development strategy that can dramatically reduce time to the clinic and launch. 

Serán utilizes a range of novel technologies and pharmaceutical manufacturing operations to overcome drug development challenges for both small and large molecules, including complex granulations, spray dried dispersions, hot melt extrudates, IR and MR tablet technologies, multiparticulates, and engineered particles for inhalation.    

Learn more about our bioavailability enhancing solutions and how they can help with your drug development efforts, here.