Scale-Up of Extrusion and Spheronization

Raman M. Iyer, Harpreet K. Sandhu, Navnit H. Shah, Wantanee Phuapradit, and Hashim M. Ahmed 

Pharmaceutical and Analytical R D, Hoffmann-La Roche Inc., Nutley, New Jersey, U.S.A. 

Although many types of pellet dosage forms have been introduced in the marketplace, a greater understanding is needed of the role of excipients, equipment, process variables, and controls involved in the pelletization process and those that govern successful scale-up from laboratory to 

Brand name Drug Company Product form Market form 

Xenical Orlistat Roche Uncoated pellets Capsule 

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Consideration should be given to the availability of small-scale equipment, which is vital for development work prior to scale-up on pilot- or production-scale machines. Equipment choice is not necessarily based on maximum throughput rate, since the subsequent processing stages (e.g., cutting, spheronization, and drying) are batch processes and are therefore, a rate-limiting factor in production. Since extrusion is a continuous process, it allows adequate production rates for most purposes with any of the above mentioned extruder types. 

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