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Incorporating QbD Elements to Minimize Spray Pattern Variation of an Active Drug Spray Coating Process Using JMP® Image Analysis and the DOE Platform (EU2018 211)

Level: Beginner
Rob Lievense, Associate Scientist for Formulation Research and Development, Perrigo

Obtaining acceptable dosage uniformity for pharmaceutical tablets coated with an active drug is dependent upon mitigating variability among the dosage units. A much higher level of precision is required from the drum tablet coating process to apply active coatings than non-functional coatings. The spray system is a key process element that is very challenging to optimize due to the need for specialized equipment to obtain volumetric measurements. An alternate approach involves trials that spray the pattern onto a simple, black paper substrate and obtain digital images of the spray pattern. The image analyzer is used to create a table of intensity values, which quantify the pattern. Graph Builder plots of the intensity profile clearly illustrate the variation in spray between and among multiple spray guns, working as an efficient analog to the typical volumetric measures. The profiles are summarized into outputs that are used with the Custom DOE platform to optimize the spray system process. JMP is utilized to incorporate Quality by Design (QbD) elements to define the design space. Optimization of this space greatly enhances the process so exacting standards set for dosage uniformity can be robustly met.

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