Article in "Iconic Success" highlights Rondol experience in HME
- Apr 6, 2025
- 2 min read
The Rondol team is proud to have been highlighted by Iconic Success for its work in developing Hot Melt Extrusion (HME) in a vertical format, a technology we see as the next innovation challenge to accelerate the broader adoption of HME for pharmaceutical applications - with impressive results in reducing both healthcare costs and harmful secondary effects.
As all Pharma HME fans well know:
- Pharmaceutical active principles (APIs) are often expensive or only available in limited quantities and therefore need small scale machines in order to minimize and control lot size and manufacturing costs;
- Both pharmaceutical grade polymers and APIs are temperature & shear sensitive which requires working on all process parameters (screw configuration, screw speed, melt pressure) in order to lower the shear forces needed and/or the temperatures required to properly mix the final product while avoiding degradation;
- Precise dosing of all product ingredients and controlling process parameters with the smallest possible deviation are crucial to monitoring the interference of the API with the other components in the formulation;
- The metallurgy of contact parts must not be reactive, additive or absorptive with the product and the equipment must be properly configured for the cleaning and validation requirements (so-called “Good Manufacturing Process”, or GMP).
- In its "classical" horizontal format, HME has demonstrated its capability to address most of these challenges but work is still needed to further minimize the quantities of APIs, improve the versatility of the extrusion process, and make both the operator interface, the cleaning process and the GMP compliance more user friendly.
To address these challenges, Rondol designed and patented its Vertical Extruder (filing in 2016, EU patent in 2019 and US Patent in 2021). This vertical design offers a uniquely small footprint of 0.5 m², compared to 2.5 m² for horizontal extruders. The system is mounted on four wheels, allowing easy movement by a single operator.
Additionally, this format enables a quicker and smoother start-up of the mixing process, delivers strong and stable pressure to extract the filament for easier downstream, and allows a more precise real-time process control for temperature sensitive materials.
Rondol would also like to warmly thank its industry and academic partners with whom we continuously work to demonstrate the benefits of Vertical HME.
Queen's University Belfast Institut Jean Lamour (IJL) BASF Pharma Solutions SEQENS Pharmaceutical Solutions Corealis Pharma Inc. Paris Saclay Cancer Cluster (PSCC) AAPS PharmSciTech
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