How our whole story with Pharma started:
Jörg Breitenbach’s PhD work at UT Austin in 1988 was first to highlight Hot Melt Extrusion (HME) potential to improve poorly soluble APIs. But there was no micro extruder capable of handling small lot sizes for these very expensive APIs.
Until 2008, when Prof. Breitenbach then CTO of Abbott (then AbbVie) urgently asked Rondol (then Rondol Technology) to develop three micro extruders to produce Kaletra tablets for the AIDS crisis in Africa (at the time, Kaletra was typically delivered via chemotherapy in hospitals—rare in Africa).
In its "classical" horizontal format, HME has since then demonstrated its capability to address most of formulation challenges:
Pharmaceutical grade polymers and APIs are temperature & shear sensitive and even minor deviations in the mixing process can affect how APIs interact with other formulation components. And Rondol horizontal extruders are for example actively being used at Catalent in the USA since 2012.
But work was 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.
Our vertical extruders are currently installed:
At Queens University in Belfast with whom we developed a POC for an improved treatment of child malaria along with Professor Gavin Andrews (Head of QUB's School of Pharmacy, inspiring leader in the research of new drug delivery platforms and oral dosage forms):
At Seqens research labs in Normandy and in Massachusetts:
At Corealis in Quebec, Canada:
And we also are regular exhibitors at AAPS such as October 2024 in Salt Lake City:
Rondol therefore designed and patented (filing in 2016, EU patent in 2019 and US Patent in 2021) the Vertical Extruder that presents a uniquely low footprint of 0.5 m2 compared to 2.5 m2 for horizontal extruders (and the machine is on 4 wheels so easy to move by one single person). Not to forget a quicker and smoother start to the mixing process, a strong and stable pressure to extract the filament for easier downstream and a more precise process control in real time for temperature sensitive materials.
Pharma
Applications
Please contact Mael Gallas at mael@rondol.com for which ever information you might need on our Pharma extruders and their ancillary downstream equipment (pelletizers, haul off etc...).