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Control de calidad de comprimidos genéricos.

Authors: Lledó López, María;

Control de calidad de comprimidos genéricos.

Abstract

La industria farmacéutica invierte en España grandes cantidades para desarrollar nuevos fármacos. Para comercializarlo, una vez sintetizada la molécula, pasa a estudios preclínicos y posteriormente a estudios clínicos. Una vez comercializada, y cuando ha expirado la patente, se desarrollan medicamentos genéricos que tienen la misma bioequivalencia que los de referencia. En el momento de fabricación se siguen estrictos controles de calidad siguiendo las normativas de BLP, BPC y NCF. Una vez terminado, según la Farmacopea, se realizan los controles de calidad establecidos para cada forma farmacéutica. En el caso de los comprimidos, y en este trabajo, se han realizado los controles de calidad de tres formulaciones distintas (formulación 1, 2 y 3) y de tres principios activos (Paracetamol, Atenolol y Ketoconazol). Los ensayos realizados según las directrices establecidas en la Farmacopea son los de Disgregación, Friabilidad, Resistencia a la rotura, Uniformidad de Contenido y Uniformidad de Masa. De las tres formulaciones estudiadas, solamente la formulación 3 ha logrado superar todos los ensayos satisfactoriamente de todos los principios activos. La formulación 1, el Paracetamol y Atenolol han pasado todos los controles y de la formulación 2, solamente el Paracetamol ha pasado dichos controles.

Keywords

CDU::6 - Ciencias aplicadas::61 - Medicina::615 - Farmacología. Terapéutica. Toxicología. Radiología, :6 - Ciencias aplicadas::61 - Medicina::615 - Farmacología. Terapéutica. Toxicología. Radiología [CDU], calidad”, “comprimidos”, “genéricos”

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Green