Development of an Ibuprofen Cream with the Aid of Quality By Design Tools
DOI:
https://doi.org/10.19142/rpq.v17i34.700Keywords:
ibuprofen cream, quality by design, design of experimentsAbstract
The drug ibuprofen has antipyretic, analgesic, and anti-inflammatory action. Despite its benefits, the most common form of administration, the oral route, is associated with side effects on the cardiovascular, renal, and gastric systems. To mitigate the adverse effects caused by its oral administration, this work sought to develop an ibuprofen cream using the concepts of Quality by Design and, consequently, the planning of experiments, to identify the main variables of the process and materials raw materials that have the greatest impact on the final characteristics of the product. A total of twenty experiments were carried out varying the formulations, temperature, agitation rate and mixing time. The cream produced was characterized in terms of physical-chemical and organoleptic characteristics such as viscosity, density, pH and micelle size. The main influencing factors in the physicalchemical aspects presented by the product are the two material factors: viscosity agents and emulsifier. Process temperature and agitation rate, although not considered significant, also impacted mainly on viscosity and micelle size characteristics, when analyzed together with other material factors.
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