Resumen

FONSECA, Juan Camilo  y  LOPEZ, Paola Garzón. Effect of compression force on critical quality attributes of immediate release tablets of furosemide. Rev. colomb. cienc. quim. farm. [online]. 2017, vol.46, n.2, pp.235-255. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v46n2.67958.

Furosemide is poorly water soluble drug (0.01825 mg/mL). Due to its low solubility and low permeability, it is labeled in class IV of the Biopharmaceutical Classification System (BCS). It is rapidly but incompletely absorbed from the gastrointestinal (GI) tract. Currently, this drug is marketed as tablets, which should be subjected to a compression process. The force applied in this compression can influence some of the quality characteristics of the product. Therefore, this investigation was carried out to determine the effect of compression force on the critical quality attributes of the product in process (hardness, friability and disintegration) and of the finished product (uniformity of dosage and dissolution). The effect on the dissolution was determined by the difference factor (f 1) and similarity factor f 2 ) of the dissolution profiles, the dissolution efficiency (ED) and mean dissolution time (TMD) parameters, which were calculated by kinetDS® academic software. The results obtained allowed to define the range of compression force for which the ED was higher than 85% and the TMD lower than 7.5 min.

Palabras clave : Furosemide; tablets; compression process; compression force; critical quality attributes.

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