Osorio FMR, Mercado CJ, Matiz MGE, León MG

Language: Spanish
References: 12
Page: 641-650
PDF size: 150.27 Kb.

ABSTRACT

Objective: to determine the biopharmaceutical equivalency of five brands if 100 mg acetylsalicylic acid tablets available on the Colombian market.
Methods: five brands of 100 mg acetylsalicylic acid tablets obtained from drugstores and pharmacies in Bogota, Cali, Medellin, Barranquilla and Cartagena, were evaluated in terms of their physical, chemical and biopharmaceutical characteristics such as variation in weight, hardness, disintegration, dissolution test, dissolution profile and efficiency and quantitation of pharmaceutically active ingredient; the pharmacopeial assays were evaluated according to the USP 37. The results analysis was used to determine the statistically significant differences and the possible interchangeability among the evaluated products.
Results: the comparative analysis of products allowed showing marked differences in terms of the in vitro release of pharmaceutically active ingredient and the noncompliance by one of the evaluated products with this important quality parameter. It is worth noting that four of the tested products comply with the official specifications of identification and measurement of the pharmaceutically active ingredient, dosage uniformity and disintegration time. In terms of the dissolution kinetics, differences were found among formulations, with a product (Mark E) having poor dissolution efficiency.
Conclusions: four products meet all the the USP-37 specifications. The results of this study provide valuable information for health authorities and patients who take these products because they bring confidence on the drug effectiveness, considering that aspirin is exempted from bioequivalence studies since it belong to Class I Biopharmaceutics Classification System showing high solubility and absorption in human consumers.

REFERENCES

1. Odegbolagun OA, Olalade OA, Osumah SE. Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially available brands of ciprofloxacin hydrochloride tablets. Tropical Journal of Pharmaceutical Research. 2007;6(3):737-745.

2. Franco LA, Matiz GE, Pájaro IB. Estudio biofarmacéutico comparativo de marcas comerciales de tabletas de ciprofloxacino disponibles en el mercado colombiano. Rev. Salud Publ. 2012;14(4):695-709.

3. Matiz GE, Erika Rodríguez E. Comparative study of the biopharmaceutical quality of commercial and generic brands of captopril and losartan tablets in the Colombian market. Rev. Colomb. Cienc. Quím. Farm. 2014;43(2):213-229.

4. Mennickent S, Yates T, Vega M, Godoy G, Saelzer R. Estudio de la estabilidad química de comprimidos de ácido acetilsalicílico mediante un control de estanterías en farmacias de Concepción, Chile. Rev. Méd. Chile. 2002;130(4):409-415.

5. Sadic J, Borgström A, Manjer J, Toth E, Lindell G. Bleeding peptic ulcer time trends in incidence, treatment and mortality in Sweden. Aliment. Pharmacol. Ther. 2009;30:392-398.

6. Ruiz E, Rubini A, Mandel J, Volonté M. Equivalencia Farmacéutica de Comprimidos conteniendo Naproxeno 500 mg. Latin American Journal of Pharmacy. 2007;26(4):530-535.

7. Vacca C, Fitzgerald J, Bermúdez J. Definición de medicamento genérico ¿un fin o un medio? Análisis de la regulación en 14 países de la Región de las Américas. Revista Panamericana de Salud Pública. 2006;20(5):314-323.

8. Risha P, Shewiyo D, Msami A, Masuki G, Vergote G, Vervaet C, Remon JP. In vitro evaluation of the quality of essential drugs on the Tanzanian market. 2002;7(8):701-707.

9. United States Pharmacopeial Convention. US Pharmacopeia, 37th. The. Rockville, MD: USPC, Imc; 2014.

10. FDA. Guidance for Industry: Dissolution testing of immediate-release solid oral 10 dosage forms. Washington: Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 1997.

11. Dressman J, Nair N. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Acetylsalicylic Acid. Journal of Pharmaceutical Sciences. 2012;101(8):2653-2667.

12. León G, Osorio MR, Matiz GE. Estudio biofarmacéutico comparativo de tabletas de acetaminofén 500 mg disponibles en el mercado colombiano. Revista Cubana de Farmacia. 2015. Vol. 49, (4). En prensa (Oct-Dic)