Instituto Nacional Of Medicamentos Iname

Argentina

Instituto Nacional Of Medicamentos Iname

Argentina
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Luque M.C.,Direccion General de Cooperacion Internacional DGCIN | Spinetto M.,Instituto Nacional Of Medicamentos Iname | Saidon P.,Organizacion Panamericana de la Salud Organizacion Mundial de la Salud
Revista Panamericana de Salud Publica/Pan American Journal of Public Health | Year: 2016

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.


Rodriguez Y.I.,Instituto Nacional Of Medicamentos Iname | Abalos I.S.,Instituto Nacional Of Medicamentos Iname | Lozano V.,Instituto Nacional Of Medicamentos Iname | Cereseto M.,Instituto Nacional Of Medicamentos Iname | And 4 more authors.
Latin American Journal of Pharmacy | Year: 2011

The aim of this study was to find out the optimal experimental conditions for Caco-2 cell culture (time and density) and permeability assays (diffusion system and drug concentration) in order to study the in vitro drugs permeability as a predictive method for drug absorption across intestinal epithelium. The integrity of the monolayers used in each assay was determined by measuring the transepithelial electrical resistance (TEER) and the permeability of the atenolol -a drug which is transported across the monolayers by the paracellular pathway-. The best working condition was obtained with a cell seeding of 7.10 4 cells/insert in a vertical difussion chamber. In such context, the monolayers had a TEER higher than 550 Ω.cm 2 and the apparent permeability coefficient of atenolol was 0.71 ± 0.19 × 10 -6 cm/seg.


Abalos I.S.,Instituto Nacional Of Medicamentos Iname | Rodriguez Y.I.,Instituto Nacional Of Medicamentos Iname | Lozano V.,Instituto Nacional Of Medicamentos Iname | Cereseto M.,Instituto Nacional Of Medicamentos Iname | And 4 more authors.
Environmental Toxicology and Pharmacology | Year: 2012

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 differenceswere 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. © 2012 Elsevier B.V.


PubMed | Instituto Nacional Of Medicamentos Iname
Type: Journal Article | Journal: Environmental toxicology and pharmacology | Year: 2012

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.

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