Designing Robust Tablet Formulas Resilient to Raw Material and Equipment Variations with the Aid of Design of Experiment (DOE) Method
International Journal of Nutrition and Food Sciences
Volume 8, Issue 6, November 2019, Pages: 78-85
Received: Jun. 18, 2019;
Published: Dec. 12, 2019
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Tian Hao, Department of Science and Technology, Pharmavite LLC, Valencia, USA
Denise Doerflein Fulk, Department of Science and Technology, Pharmavite LLC, Valencia, USA
In tablet production, the physical properties of tablet products are found to change from batch to batch occasionally, which could be caused by raw material and equipment variations. This article focuses on how to design robust formulas resilient to raw material and equipment variations with the aid of Design of Experiment (DOE) method, how to optimize the concentrations of each individual ingredient, and how to avoid the common production issues related to tablet capping, chipping, and dusting problems. The impacts of particle sizes and equipment on compression behaviors were experimentally evaluated and explained with a theoretical hypothesis. The main goal is to show how tablet product quality is controlled from fundamental scientific principles when many active ingredients are present in a single formula, hard to be engineered and dramatically different from the pharmaceutical products. Our findings may provide insightful clues on tablet formulations and design strategies.
Denise Doerflein Fulk,
Designing Robust Tablet Formulas Resilient to Raw Material and Equipment Variations with the Aid of Design of Experiment (DOE) Method, International Journal of Nutrition and Food Sciences.
Vol. 8, No. 6,
2019, pp. 78-85.
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