Catalent expands OptiMelt hot melt extrusion capabilities

The investment includes the addition of equipment to enhance development capabilities for preclinical and early clinical phase development, as well as adding downstream processing technologies to support HME formulations.

Catalent Pharma Solutions has invested a further $5 million at the company’s Somerset, New Jersey, drug development center of excellence to expand its OptiMelt hot melt extrusion (HME) capabilities.

As a technology, HME offers several advantages, including development of amorphous dispersions and controlled and modified drug delivery to enhance a drug’s bioavailability, as well as taste masking of bitter 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," commented 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 IIb formulation, analytical, and manufacturing solutions for orally delivered small molecules.

Catalent’s 265,000-sq ft headquarters and development center in Somerset has a long track record of successfully developing, launching, and manufacturing many oral treatments for leading global innovators. The site houses state-of-the-art analytical labs, pilot and clinical scale equipment including hot melt extrusion and fluid-bed processing and has significant expertise in handling potent and US Drug Enforcement Administration (DEA) compounds for capsules, tablets, minitablets and multi-particulates.

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