Abstract

MATIZ-MELO, Germán Eduardo; RODRIGUEZ-CAVALLO, Erika  and  OSORIO, María del Rosario. Comparative study of the biopharmaceutical quality of commercial brands and multisource of ibuprofen tablets in the Colombian market. Rev. colomb. cienc. quim. farm. [online]. 2017, vol.46, n.1, pp.48-70. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v46n1.67291.

The most widely used drugs in the world are non-steroidal anti-inflammatory analgesics (NSAIDs), because of their ability to relieve pain, a condition common to many pathologies. One of the widely used NSAIDs in Colombia is Ibuprofen. To assess the conformity of products and determine their biopharmaceutical equivalence, a total of 10 commercial products were purchased and evaluated. These were bought in commercial establishments of four of the main cities of the country: Cartagena, Barranquilla, Bogota and Cali. For this purpose, the physical, chemical and biopharmaceutical characteristics of the tablets were evaluated, such as weight variation, hardness, disintegration, dissolution test, dissolution profile, dissolution efficiency and active ingredient titration from validated methodologies. The pharma-copoeial tests were evaluated according to USP 39. The results allowed to establish that all evaluated products met the specifications of the pharmacopoeia with respect to content of active ingredient and test of dissolution. Regarding biopharmaceutical behavior, although all brands comply with pharmacopoeial specifications, only three of the ten brands evaluated are biopharmaceutically equivalent to the innovator. The results of this work allow proposing to the scientific community, the determination of biopharmaceutical equivalence as an element of support in making purchasing decisions in the pharmaceutical service.

Keywords : Ibuprofen; NSAIDs; biopharmaceuticals; dissolution; f2 similarity factor; biopharmaceutical classification system.

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