MUPS (Multiple Unit Pellet System) Production
MUPS is a multiparticulate pharmaceutical solid dosage form produced by compressing a mixture of drug-containing pellets and powder excipients. The pellets have a spherical core that contains or is coated with the active ingredient, and have one or more protective layers (cellulosic and acrylic polymers) to control drug release.
MUPS technology has been adopted by the pharmaceutical industry as an alternative to conventional immediate or modified release tablets. Offering increased bioavailability and improved pharmacological properties, including sustained release, enteric-coated pellets containing different drugs, and subsequently tableted, can be used to protect the API from gastric media. Compressing pellets reduces the esophageal residence time, compared with capsules and improves physicochemical stability.
Further, compared with other delivery systems, MUPS formulations offer a lower risk of local irritation and toxicity, reduced dose dumping, minimal plasma concentration fluctuations and the ability to administer high potency products. More reproducible pharmacokinetic behavior and lower intra/inter-subject variability compared with conventional formulations have also been reported. Other benefits include taste masking and controlled absorption.
Production and Manufacturing
MUPS formulations can be processed by extrusion–spheronization, pelletization, granulation, spray drying and spray congealing, but are typically prepared by dry blending the pellets and excipients in a bin blender and discharging the mixture into a drum or IBC. The IBC is then transported to a storage area or immediately transferred to the compression room.
Producing MUPS tablets using conventional bin blending to feed a tablet press is reported by many pharmaceutical manufacturers to pose significant challenges regarding productivity and batch content uniformity. As a result, to increase process yield and guarantee tablet quality, an innovative continuous dosing, blending and compression system has been developed by GEA that eliminates these production inefficiencies and product quality risks. Segregation is kept to an absolute minimum and online process monitoring detects out-of-specification (OOS) tablets.
The continuous dosing-blending-compression system is now available at GEA’s test facilities in Halle, Belgium, for customer product trials.