Pharmaceutical Formulations & Drug Delivery

Given the need to produce medicines of the highest quality and improve compeÆŸÆŸ veness in the pharmaceuÆŸ cal, industrial and healthcare fi elds, many companies have adopted Quality by Design (QbD) to guarantee the quality of their products. The main objecÆŸ ve of this research is to develop an immediate release Rupatadine fumarate 10 mg tablets formulaÆŸ on by direct compression, through a Quality by Design approach in Costa Rica. Quality by Design elements such as Target Product Profi le, Quality Target Product Profi le and the CriÆŸ cal Quality AÆ© ributes were defi ned. In the preformulaÆŸ on study, compaÆŸ bility tests were carried out between the raw materials by Diff erenÆŸ al Scanning Calorimetry, Thermogravimetric analysis and Near Infrarred Spectroscopy. A Quality Risk Management done through Ishikawa’s diagram, allowed the defi niÆŸ on of the CriÆŸ cal Material AÆ© ributes. Three formulaÆŸ on prototypes were prepared by direct compression and the CriÆŸ cal Process Parameters were defi ned. In addiÆŸ on, the impact of compression on the crystalline state of the formulas was studied through Diff erenÆŸ al Scanning Calorimetry, Thermogravimetric analysis and X-Ray Diff racÆŸ on. The prototypes were analyzed in terms of organolepÆŸ c properÆŸ es, idenÆŸfi caÆŸ on, potency, content uniformity, dissoluÆŸ on, disintegraÆŸ on, friability and loss by drying. Therefore, the approaching of a Quality by Design model to the current development allowed to obtain saÆŸ sfactory results in all prototypes. The excipients to be used can be lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, pregelaÆŸnized starch, magnesium stearate, stearic acid and PVP K-30.