The authors describe the measurement of the effusivity of blended and unblended commercial pharmaceutical formulations to effectively differentiate between materials and then to determine if the effusivity changed with blending time. Eight components of a commercially available formulation were tested to determine if their effusivity values were unique enough to permit them to be distinguished.Two aliquots were tested, and the variance between the two was 1.6%.The effusivity values indicated that the blend of the eight components was sensitive to uniformity. The eight components then were blended and samples were extracted at times ranging from 2 to 60 min.The results, when compared with assay results from the drug manufacturer, showed excellent agreement in terms of uniformity determination.
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validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Monday, August 18, 2008
Monitoring Blend Uniformity with Effusively
Journal:
Pharmaceutical Technology APRIL 2002
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