Somerset, NJ and Ludwigshafen, Germany – Catalent Pharma Solutions and BASF have entered into a broad collaboration and Open Alliance to provide solutions to overcome bioavailability challenges of new molecular entities with solubility or permeability challenges.
The companies aim to combine their world-leading expertise to provide pharmaceutical customers with a unique range of seamless solutions to address pipeline challenges with a large majority of BCS Class II and IV poorly bioavailable compounds. From feasibility studies across multiple technologies, solid state chemistry, consulting and training, expert formulation services, excipients and optimal dose form development, to scale-up and supply, BASF and Catalent provide a full solution to one of the most important pipeline challenges in the industry – getting better treatments to market faster.
BASF has extensive ingredient formulation and material science expertise, as well as world-class excipient products and has been a leader in developing hot melt extrusion technology solutions. Catalent is the #1 global partner in drug formulation and development as well as in finished oral dose manufacturing, with more than 75 years of experience in providing bioavailability solutions.
Ian Muir, President of Catalent’s Modified Release Technologies business unit, stated, “We are very pleased to collaborate with BASF to bring this unique and impactful solution to our customers. BASF brings significant strengths and expertise that match very well with Catalent’s expertise in offering multiple solutions for poorly soluble compounds; including our Softgel platform and OptiMelt™ hot melt extrusion technologies. Our proven track record of developing, scaling up and manufacturing pharmaceutical products globally also provides for an important seamless integration from development to commercialization and ongoing supply.”
"We are glad to bring our in depth knowledge of polymeric excipients, including innovations like SOLUPLUS® into this open alliance", says Ralf Fink, VP Global Marketing at BASF Pharma Ingredients & Services business unit. "With our broadest portfolio of solubilizers and excipients for hot-melt extrusion, coupled with Catalent’s strengths in development, formulation and manufacturing, we are in a unique position to solve the solubility challenge. With this open alliance, we help our customers in the development and commercialization of drugs with poor bioavailability."
Catalent has made significant investments in OptiMeltTM hot melt extrusion and fluid bed lab, pilot, and commercial scale equipment at its Schorndorf, Germany facility, OptiMeltTM hot melt extrusion at its Somerset, NJ facility, training and seamless method development to operationalize this open alliance. BASF is continuously investing in new excipients to provide advanced solutions for the pharmaceutical industry.
Source: Catalent