ABSTRACT
Scale-up of any physical process implies increasing the batch size or a procedure for applying the same process to different output volumes. Scale-up problems may require post-approval changes that affect formulation composition, site change, and manufacturing process or equipment changes. Generally, there should be minimal problems when changing scale within the same subclass. Higher-output plug-forming machines of the same manufacturer's series typically do not make plugs any faster than the lower-output machines. Since the multiple tamping principle of the dosing disc machine is more efficient at densification than the single stroke dosator machine, dosing disc machines may be able to accommodate a broader range in powder properties. Dissolution may be affected by differences in plug density/porosity owing to differences in such variables as compression force, dwell time, rates of compression, and the number of tamping or compression events involved in forming the plugs. Multiple tamping in a dosing disc machine may affect dissolution.
