ABSTRACT
RESUMEN Los medicamentos genéricos son una alternativa para mejorar el acceso a las medicinas que la población necesita y, además, hacen más sostenibles los programas de salud públicos y privados. Se ha seleccionado información y evidencia científica sobre este tipo de medicamentos de tal manera que los lectores -médicos, financiadores, organismos públicos y privados-puedan conformar su propia opinión y ayudar a tomar las decisiones más efectivas y eficientes. La relación existente entre los precios de estos productos y la protección de la propiedad intelectual a través de las patentes de los medicamentos es un centro de conflictos entre la industria farmacéutica y los sistemas de salud. En los Estados Unidos, la ley Hatch-Waxman ha cumplido una función muy importante al estimular el desarrollo de medicamentos genéricos. En un mismo intento, la Unión Europea (UE) ha desarrollado, a través de la Agencia Europea del Medicamento (EMA), una homogeneización en materia de autorización de medicamentos y exclusividad de los datos.
SUMMARY Generic medicines give the chance to improve access to medicaments that the population needs, and the possibility of making public and private health programs more sustainable. Information and scientific evidence on this type of medicines has been selected in such a way that the readers - doctors, financiers, public and private organizations - can shape their own opinion and help take the most effective and efficient decisions. The relationship between the prices of these products and the protection of intellectual property through patents for medicines is a center of conflicts between the Pharmaceutical Industry and health systems. In the United States, the Hatch-Waxman Act has played a very important role in stimulating the development of generic drugs. By his side, the European Union (EU) has developed, through the European Medicines Agency (EMA), a homogenization in terms of authorization of medicines and exclusivity of data.
ABSTRACT
Tobramycin, is a water soluble aminoglycoside antibiotic produced by the fungus Streptomyces tenebrarius and used in a variety of pharmaceutical applications including ophthalmic solutions, suspensions and ointments; inhalation solutions and intravenous administration. There are commercially available eye drops formulations in the Argentinian market that have different conservation conditions. We formulated six eye drops solutions, studied their stability at 2-8°C, 25°C, and 40°C, 75% RH and quantified using USP method. Only half of the formulations studied were found to be stable for two years at ambient temperature which is their expected expiry date and only one for three years in the same condition. One system was unstable in the three conservation conditions studied, including appearance and pH.