Catalent Pharma Solutions has announced several advancements and expansion of its OptiMelt™ Hot Melt Extrusion (HME) capabilities in Somerset, NJ.
Catalent’s OptiMelt technology is designed to help innovators overcome bioavailability challenges and create optimal delivery profiles and better dose forms.
The company has announced that results from over 10 feasibility studies for customers utilizing OptiMelt technology have demonstrated its bioavailability enhancing capabilities.
These programs were conducted across various therapeutic areas and stages of development, with several advancing to further development scale, which will ultimately result in better treatments for patients given eventual regulatory product approvals.
To create an end-to-end capability, Catalent has announced the addition of a commercial scale extruder at its Somerset facility, supplementing the development scale equipment already on site.
This added investment will allow Catalent to continue to meet high customer demand for OptiMelt while also expanding its offerings to include lab, development, and commercial scale hot melt extrusion co-located with extensive final dose form technologies across its Somerset and Schorndorf, Germany facilities.
Commenting on the development milestone and capacity expansion, Barry Littlejohns, President of Catalent’s new Advanced Delivery Technologies business, said “Our OptiMelt HME platform has continued to strengthen in the last year as development partners have recognized the benefits of our technologies. Our added commercial HME capacity will support customers’ projects as they transition to later phase clinical development and commercial supply, and also new customers desiring commercial scale direct tech transfers to our Somerset facility.”
Catalent’s integrated OptiMelt platform combines development and scale-up of HME technology with leading expertise in oral controlled release formulation and final dose form development including tablets, capsules and granules, offering customers an integrated solution to the formulation and commercialization of poorly soluble drugs.