RESUMO
Objective To describe the benefits obtained through South-South and triangular cooperation as a potential tool for strengthening medicine quality control in official medicines control laboratories (OMCLs) of the Region of the Americas. Methods Descriptive study of the project for strengthening drug quality control in OMCLs of the Caribbean community (CARICOM). Results Staff members of Argentina's National Administration for Drugs, Food, and Medical Technology (ANMAT) provided training to professionals from Guyana, Jamaica, Suriname, and Trinidad and Tobago. The project was funded by the Argentine Fund for South-South and Triangular Cooperation (FO.AR) and coordinated by the Pan American Health Organization (PAHO). Documents on good laboratory practice (GLP) developed by the World Health Organization (WHO) and the Pan American Network for Drug Regulatory Harmonization (PANDRH) were reviewed, and the area of physical and chemical controls was strengthened, primarily for drugs to treat tuberculosis, malaria, and HIV/AIDS, all of which are strategically important to those countries. Conclusion This type of collaboration makes it possible to share experiences, optimize resources, harmonize procedures and regulations, and strengthen human resource capacities. In addition, it is a valuable tool for reducing asymmetries in various areas among the different countries of our Region.
Assuntos
Cooperação Internacional , Laboratórios/normas , Preparações Farmacêuticas/normas , Controle de Qualidade , Argentina , Região do Caribe , Guias como Assunto/normas , Guiana , Humanos , Jamaica , Desenvolvimento de Pessoal , Suriname , Trinidad e TobagoRESUMO
The aim of this research has been to determine the biperiden hydrochloride permeability in Caco-2 model, in order to classify it based on the Biopharmaceutics Classification System (BCS). The World Health Organization (WHO) as well as many other authors have provisionally assigned the drug as BCS class I (high solubility-high permeability) or III (high solubility-low permeability), based on different methods. We determined biperiden BCS class by comparing its permeability to 5 pre-defined compounds: atenolol and ranitidine hydrochloride (low permeability group) and metoprolol tartrate, sodium naproxen and theophylline (high permeability group). Since biperiden permeability was higher than those obtained for high permeability drugs, we classified it as a BCS class I compound. On the other hand, as no differences were obtained for permeability values when apical to basolateral and basolateral to apical fluxes were studied, this drug cannot act as a substrate of efflux transporters. As a consequence of our results, we suggest that the widely used antiparkinsonian drug, biperiden, should be candidate for a waiver of in vivo bioequivalence studies.
Assuntos
Antiparkinsonianos/metabolismo , Biperideno/metabolismo , Antiparkinsonianos/classificação , Transporte Biológico , Biofarmácia/classificação , Biperideno/classificação , Células CACO-2 , Humanos , Permeabilidade , SolubilidadeRESUMO
INTRODUCCIÓN: la Organización Mundial de la Salud (OMS) declaró la pandemia de gripe A H1N1 en 2009. La autoridad sanitaria argentina promovió el desarrollo y validación de un método de control de calidad de productos farmacéuticos que contenían oseltamivir como principio activo. OBJETIVO: Desarrollar y validar un método de valoración para oseltamivir en las formas farmacéuticas de cápsulas y polvo para suspensión oral. MÉTODOS: La valoración de oseltamivir fue realizada mediantecromatografía líquida de alta eficacia (CL AE), con elusión isocrática a una temperatura de 50°C, columna Phenomenex Luna RP-8, solución reguladora de acetato pH 5,39 y metanol como fase móvil. La detección se realizó con detector de arreglo de diodos a 230 nm. El método fue validado mediante la evaluación de especificidad, retención en filtros, estabilidad de las soluciones, linealidad, exactitud, precisión y robustez. RESULTADOS: Se desarrolló y validó un método por CLAE para la valoración de oseltamivir, el cual fue aplicado con resultados satisfactorios en el análisis de 11 especialidades medicinales de laboratorios nacionales e internacionales. CONCLUSIONES: El método desarrollado puede aplicarse para el control de todos los productos del mercado argentino en sus dos formas farmacéuticas.
INTRODUCTION: Tthe World Health Organization(WHO) declared the pandemic influenza A H1N1 virus infection in 2009. Argentine health authorities promoted the development and validation of a quality control method for pharmaceutical products containing oseltamivir as active ingredient. OBJECTIVE: To develop and validate a method for oseltamivir quantitative determination in the pharmaceutical dosage forms of capsules and powder for oral suspension. METHODS: The determination of oseltamivir was performed using a high performance liquid chromatography (HPLC) method under an isocratic elution, at a temperature of 50°C with a RP-8 Phenomenex Luna column and a mobile phase containing acetate buffer pH 5.39 and methanol. The detection was performed at 230nm with a diodearray detector. The method was validated by evaluating specificity, filter retention, solution stability, linearity, accuracy, precision and robustness. RESULTS: An HPLC method was developed and validated for quantitative determination of oseltamivir, and it was successfully applied in the analysis of eleven medical products from national and international laboratories. CONCLUSIONS:The method developed can be applied for control of all products on the Argentine market in its two pharmaceutical forms.