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Dissolution applications involving USP Apparatus 4 have increased recently (see article by Will Brown,USP). Many novel dosage forms are not amenable to the conventional dissolution techniques such as USP Apparatus 1 (rotating basket) or USP Apparatus 2 (rotating paddle).The flow through cell design of the USP Apparatus 4 is a more practical approach to dealing with microspheres,liposomes, stents,and other novel dosage forms. Lancaster Laboratories uses the Sotax Apparatus 4 CE 7 SMART System.This system includes a 7-piston pump,a media switching unit,a heating bath,flow through cells,a fraction collector,a data system,and an Agilent 8453 UV/Vis spectrophotometer.This system can be operated in an open system configuration (Figure 1) where media flows through the cell containing the drug product to a fraction collector or in a closed system configuration (Figure 2) where a finite amount of media is constantly recirculated through the cell.This article will discuss the qualification and validation activities of this equipment to support current good manufacturing practices (cGMPs).

Qualification and Validation of USP Apparatus 4