Catalent Expands OptiMelt Capabilities at Somerset CoE

Investing an additional $5 million in manufacturing and analytical equipment to enhance development capabilities to support HME formulations

Catalent Pharma Solutions is investing an additional $5 million at the company’s Somerset, NJ, drug development center of excellence to expand its OptiMelt hot melt extrusion (HME) capabilities.
 
HME is used in the development of amorphous dispersions and controlled and modified drug delivery to enhance a drug’s bioavailability, as well as taste masking of bitter active pharmaceutical ingredients (APIs). The investment will include the addition of a number of pieces of manufacturing and analytical equipment to enhance development capabilities for preclinical and early clinical phase development, as well as adding downstream processing technologies to support HME formulations.
 
"The developmental challenges to overcome issues with drug solubility and bioavailability are well documented, and our OptiMelt HME technology is one of many potential solutions that Catalent has to offer," said Jonathan Arnold, president of Oral Drug Delivery at Catalent. "Our strategy is to work with drug innovators to optimize the formulation and delivery method of a drug, and HME enables us to develop more patient centric dose forms, including controlled release."
 
In 2018, Catalent announced an investment in the Somerset facility to create a new drug development center of excellence, which, alongside sites in San Diego, California and Nottingham, UK, offer formulation and development services focused on preclinical to clinical phase 2b formulation, analytical, and manufacturing solutions for orally delivered small molecules.
 
Catalent’s 265,000 square-foot headquarters and development center in Somerset houses analytical labs, pilot and clinical scale equipment including hot melt extrusion and fluid-bed processing and has expertise in handling potent and U.S. Drug Enforcement Administration (DEA) compounds for capsules, tablets, minitablets and multi-particulates.

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