Drug contamination from the perspective of higher education: University social responsibility experiences in Argentina and Chile

La presencia de fármacos o medicamentos en el medioambiente es un tema de preocupación global. Los medicamentos vencidos y/o en desuso domiciliario, no posibles de ser utilizados, deben gestionarse como residuos especiales o peligrosos (en virtud de la legislación vigente en cada jurisdicción), ya que su gestión inadecuada puede causar serios efectos negativos sanitarios y medioambientales. En los países de Latinoamérica la regulación asociada a este fenómeno es escasa. El objetivo de este trabajo fue abordar la problemática de la farmacontaminación mediante la presentación de dos experiencias exitosas, basadas en Gestión Posconsumo de Medicamentos, implementadas en el marco de programas de formación estudiantil en carreras de Farmacia de universidades latinoamericanas, como una modalidad de Responsabilidad Social Universitaria. A través de estas iniciativas se ofreció una alternativa transitoria de mitigación del impacto negativo en salud y ambiente del desecho inapropiado de los residuos farmacéuticos domiciliarios. Ambas experiencias latinoamericanas demostraron la importancia de fomentar la Responsabilidad Social Universitaria, como mecanismo de conexión de los estudiantes de nivel superior con el entorno social y la posibilidad de dar respuesta a problemáticas reales, como lo es la farmacontaminación.A presença de drogas ou medicamentos no meio ambiente é um tema de preocupação global. Esses medicamentos vencidos e/ou fora de uso em casa, que não podem ser consumidos, devem ser gerenciados como resíduos especiais ou perigosos (de acordo com a legislação vigente em cada jurisdição), pois o manejo inadequado pode causar graves efeitos negativos à saúde e ao meio ambiente. Nos países latino-americanos, a regulamentação associada a este fenómeno é escassa. O objetivo deste trabalho foi abordar o problema da contaminação de medicamentos apresentando duas experiências bem-sucedidas através de práticas de Gestão de Medicamentos Pós-Consumo, implementadas no âmbito de programas de formação de estudantes em duas especialidades de Farmácia de universidades latino-americanas como modalidade de Responsabilidade Social Universitária. Através destas iniciativas, foi oferecida uma alternativa temporária para mitigar o impacto negativo na saúde e no ambiente da eliminação inadequada de resíduos farmacêuticos domésticos. Ambas as experiências latino-americanas demonstram a importância de promover a Responsabilidade Social Universitária, como mecanismo de conexão dos estudantes de nível superior com o meio social e possibilidade de resposta a problemas reais, como a contaminação por drogas.Presence of drugs or medicines in the environment constitutes a global concern. Unused or expired medicines, which cannot be consumed, should be handled as special or hazardous waste (according to current legislation in each jurisdiction), given their potential to cause negative impacts on public and environmental health. In Latin American countries regulation in this regard is scarce. The objective of this work was to address the problem of drug contamination through the presentation of two successful experiences, based on Post-Consumption Drug Management, implemented within the framework of student training programs in Pharmacy careers at Latin American universities, as a modality of University Social Responsibility. Transitory responses were given through these initiatives in terms of mitigating the negative effects of unused/expired drug inappropriate disposal. Both examples demonstrate the importance of fostering social responsibility of universities as a connection mechanism between students and communities and also to provide response to real public health issues including drug-related pollution.Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina. Sociedad Iberoamericana de Salud Ambiental; ArgentinaFil: Müller Ramirez, C.. Universidad de Concepción; Chil

Drug contamination from the perspective of higher education: University social responsibility experiences in Argentina and Chile

La presencia de fármacos o medicamentos en el medioambiente es un tema de preocupación global. Los medicamentos vencidos y/o en desuso domiciliario, no posibles de ser utilizados, deben gestionarse como residuos especiales o peligrosos (en virtud de la legislación vigente en cada jurisdicción), ya que su gestión inadecuada puede causar serios efectos negativos sanitarios y medioambientales. En los países de Latinoamérica la regulación asociada a este fenómeno es escasa. El objetivo de este trabajo fue abordar la problemática de la farmacontaminación mediante la presentación de dos experiencias exitosas, basadas en Gestión Posconsumo de Medicamentos, implementadas en el marco de programas de formación estudiantil en carreras de Farmacia de universidades latinoamericanas, como una modalidad de Responsabilidad Social Universitaria. A través de estas iniciativas se ofreció una alternativa transitoria de mitigación del impacto negativo en salud y ambiente del desecho inapropiado de los residuos farmacéuticos domiciliarios. Ambas experiencias latinoamericanas demostraron la importancia de fomentar la Responsabilidad Social Universitaria, como mecanismo de conexión de los estudiantes de nivel superior con el entorno social y la posibilidad de dar respuesta a problemáticas reales, como lo es la farmacontaminación.A presença de drogas ou medicamentos no meio ambiente é um tema de preocupação global. Esses medicamentos vencidos e/ou fora de uso em casa, que não podem ser consumidos, devem ser gerenciados como resíduos especiais ou perigosos (de acordo com a legislação vigente em cada jurisdição), pois o manejo inadequado pode causar graves efeitos negativos à saúde e ao meio ambiente. Nos países latino-americanos, a regulamentação associada a este fenómeno é escassa. O objetivo deste trabalho foi abordar o problema da contaminação de medicamentos apresentando duas experiências bem-sucedidas através de práticas de Gestão de Medicamentos Pós-Consumo, implementadas no âmbito de programas de formação de estudantes em duas especialidades de Farmácia de universidades latino-americanas como modalidade de Responsabilidade Social Universitária. Através destas iniciativas, foi oferecida uma alternativa temporária para mitigar o impacto negativo na saúde e no ambiente da eliminação inadequada de resíduos farmacêuticos domésticos. Ambas as experiências latino-americanas demonstram a importância de promover a Responsabilidade Social Universitária, como mecanismo de conexão dos estudantes de nível superior com o meio social e possibilidade de resposta a problemas reais, como a contaminação por drogas.Presence of drugs or medicines in the environment constitutes a global concern. Unused or expired medicines, which cannot be consumed, should be handled as special or hazardous waste (according to current legislation in each jurisdiction), given their potential to cause negative impacts on public and environmental health. In Latin American countries regulation in this regard is scarce. The objective of this work was to address the problem of drug contamination through the presentation of two successful experiences, based on Post-Consumption Drug Management, implemented within the framework of student training programs in Pharmacy careers at Latin American universities, as a modality of University Social Responsibility. Transitory responses were given through these initiatives in terms of mitigating the negative effects of unused/expired drug inappropriate disposal. Both examples demonstrate the importance of fostering social responsibility of universities as a connection mechanism between students and communities and also to provide response to real public health issues including drug-related pollution.Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina. Sociedad Iberoamericana de Salud Ambiental; ArgentinaFil: Müller Ramirez, C.. Universidad de Concepción; Chil

Pharmaceutical equivalence and stability of Furosemide tablets in Argentina

Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. The aim of the present work was to evaluate and compare critical quality attributes, including in vitro dissolution characteristics, of eight furosemide tablet brands of Argentine market, and determine their pharmaceutical equivalence. Furthermore, this research aimed to evaluate the effect of storage (twelve months after natural aging conditions) over those critical properties. At time zero of analysis, all evaluated samples fulfilled specifications for friability, hardness, disintegration, assay, uniformity of dosage units and dissolution tests. After storage, all formulations fulfilled the assay and dissolution test specifications, with no statistical differences recorded for the obtained results. Comparison of dissolution profiles was also assessed in terms of the model independent parameter called dissolution efficiency. Highly significant differences were recorded between reference and four multisource formulations. The same differences were found at the beginning of the study (time zero) and after one year of storage. One product presented the lowest dissolution efficiency results, associated to highly significant differences when compared to the other formulations. However, the obtained results reveal that the evaluated samples complied with codified quality control tests, and consequently can be qualified as pharmaceutical equivalents. Natural aging conditions clearly not affected the stability of the evaluated products.Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentin

Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets

Dissolution studies have evolved from a simple quality control test to a surrogate of in vivo interchangeability. Pharmaceutical equivalents are drug formulations with the same molar amount of the same active pharmaceutical ingredient (API), in the same dosage form, meet comparable quality standards, and are intended to be administered by the same route. Pharmaceutical equivalents imply therapeutical equivalence when, after administration, their effects are essentially the same; these effects can be demonstrated by bioequivalence studies or, in some cases, by in vitro studies based on the Biopharmaceutics Classification System. In this scheme, biowaivers are recommended for immediate-release solid oral dosage forms containing Class 3 drugs (like Metoclopramide) using dissolution testing as a surrogate for in vivo bioequivalence studies, with special consideration regarding excipient composition. The present work aimed to compare in vitro dissolution characteristics and other critical quality attributes of Metoclopramide tablets purchased in Argentina to establish their pharmaceutical equivalence and similarity. All evaluated products fulfill the pharmaceutical equivalence criteria. Three of the tested products and the reference formulation complied with the criteria for ‘very rapidly dissolving,’ so they could be described as essentially similar. Nevertheless, it is important to have access to additional information about the excipient composition of these formulations to assure a safe interchangeability process for this Class 3 drug.Fil: Varillas, Maria Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Brevedan, Marta ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentin

Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina

Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market. For this purpose, evaluation of labels and patient information leaflets, description and mean weight of tablets, uniformity of dosage units, assay, hardness, friability, disintegration and dissolution tests were carried out, in compliance with the Argentine Pharmacopeia. The dissolution efficiency (DE) was obtained from the area under the drug dissolution curve, and the profiles were compared statistically by ANOVA. All samples met criteria for the assay, uniformity of dosage units, friability, hardness, disintegration tests, and dissolution test in Stage 1. Sample D presented the lowest dissolution performance, in terms of DE values, with highly significant differences in comparison with the rest of the evaluated samples; however, the results of this study indicate that HCTZ tablets available in Argentina successfully pass all established quality control tests and can be considered pharmaceutical equivalents.Fil: Varillas, M.A. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Brevedan. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentin

Comparative assessment of critical quality attributes of sildenafil tablets

Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentin

Critical Quality Attributes and Pharmaceutical Equivalence Assessment of Allopurinol Tablets in Argentina

Dissolution studies have evolved from a simple quality control test to an indicator of biopharmaceutical performance and alternative for in vivo equivalence and interchangeability assessment. Pharmaceutical equivalents imply products formulated with the same active pharmaceutical ingredient (API), in the same quantity and dosage form, that are intended to be administered by the same route fulfill the same quality criteria. The medicine market in Argentina is composed mostly of multisource products that are supposed to be pharmaceutical equivalents, but the generic market here is different from other parts of the world. In this scenario, the comparison of different products formulated with the same API becomes essential. Allopurinol, the drug of choice in the treatment of gout and tumor lysis syndrome, is classified as an essential medicine according to the World Health Organization. The present work aimed to compare critical quality attributes and in vitro dissolution characteristics of Allopurinol tablets purchased in Argentina to establish pharmaceutical equivalence. All evaluated products fulfilled the pharmaceutical equivalence criteria. Three of the tested products (the reference and two multisource formulations) comply with the criteria for ‘very rapidly dissolving’ and can be described as similar.Fil: Varillas, María Alejandra. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentin

Post-consumption management of medicines in Argentina: National scenario in the international context

A medida que aumenta la esperanza de vida y la población envejece, también lo hace el uso de medicamentos consumidos por ella. Una de las consecuencias negativas de esta demanda es la cantidad de residuos farmacéuticos, desechados en los domicilios ya sea por encontrarse vencidos, dañados o en desuso. Su adecuada eliminación resulta fundamental a fin de evitar daños al ambiente, que de manera directa o indirecta impacta en la salud humana. Por esta razón, los países suelen incluir en sus agendas las políticas ambientales que buscan mitigar las consecuencias de esta farmacontaminación. Así se implementan programas que suelen ser coordinados por las autoridades sanitarias locales, los cuales tienen como objetivo reducir el riesgo de contaminación del medio ambiente y la afectación de la salud pública. En Argentina, en cambio, se evidencia un vacío legal en lo concerniente al abordaje de la farmacontaminación. Los resultados obtenidos en este trabajo permiten detectar 55 acciones concretas, promovidas por diversos entes, que van desde la concientización poblacional hasta la implementación de herramientas puntuales de gestión posconsumo. En virtud de los resultados obtenidos a partir de iniciativas emprendidas por organizaciones civiles y profesionales, se denota que para resolver esta problemática se requiere el compromiso político por parte de autoridades gubernamentales para instaurar políticas nacionales que, al ser acatadas, produzcan beneficios que perduren en el tiempo.Como aumento da expectativa de vida aumenta e a população envelhece, também aumenta o uso de drogas consumidas por ela. Uma das consequências negativas dessa demanda é a quantidade de resíduos farmacêuticos, descartados nas residências, seja por prazo de validade, danificado ou em desuso. Seu descarte adequado é fundamental para evitar danos ao meio ambiente que impactem direta ou indiretamente a saúde humana. Por esse motivo os países costumam incluir em suas agendas políticas ambientais que buscam mitigar as consequências dessa fármacopoluição. Assim são implementados programas que geralmente são coordenados pelas autoridades locais de saúde, cujo objetivo é reduzir o risco de contaminação ambiental e o impacto na saúde pública. Na Argentina, por outro lado, há indícios de um vácuo legal quanto à abordagem da fármacopoluição. Os resultados obtidos neste trabalho permitem detectar 55 ações específicas, promovidas por diversas entidades, que vão desde ações de sensibilização da população até à implementação de ferramentas específicas de gestão pós-consumo. Em virtude dos resultados obtidos com as iniciativas empreendidas pelas organizações civis e profissionais, para solucionar esse problema, é necessário o compromisso político das autoridades governamentais para o estabelecimento de políticas nacionais que, quando aderidas, produzem benefícios que perduram no tempo.The increased life expectancy and the aged population have contributed to the prolonged use of drugs. Consequently, one negative result is the amount of pharmaceutical wastes, discarded in each home, either because they are expired, damaged or in disused. In order to prevent environmental damages, it is essential to eliminate pharmaceutical wastes properly since they have a direct or indirect impact on people’s health. That is the reason why many countries often include environmental policies in their agendas with the aim of mitigating pharmaceutical pollution’s consequences. These plans, which are coordinated by local health authorities, set out to reduce the risk of environmental contamination as well as the impact on public health. In Argentina, by contrast, there is a legal vacuum related to the approach of pharmaceutical pollution. The obtained results allow the detection of 55 specific actions, promoted by various entities, ranging from awareness campaigns to the implementation of specific post-consumption management instruments. In view of all the research on the subject by civil and professional organizations, it is not possible to solve this problematic situation without the political commitment to establish national policies, that after being adopted, provide benefits that last over time.Fil: Fontana, Marcela. Universidad de Mendoza; Argentina. Grupo Argentino para el Uso Racional de Medicamentos; ArgentinaFil: Vicentin, Emilce. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; ArgentinaFil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca; Argentina. Sociedad Iberoamericana de Salud Ambiental; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia; Argentin

Albendazole Solid Dispersions: Influence of Dissolution Medium Composition on In Vitro Drug Release

The rate-limiting step to drug absorption is often dissolution from the dosage form, especially for poorly soluble com-pounds. Two possibilities for improving the dissolution of these drugs are to increase the available surface area and to im-prove their apparent solubilities under physiologically relevant conditions with surfactants as wetting agents. Albendazole (ABZ), one of the most effective broad-spectrum antihelminthic agents, has a very low aqueous solubility, which leads to an erratic availability. Solid dispersions (SD) with different amounts of carriers (P188 and PEG6000) were formulated to improve the ABZ dissolution rate. When the dissolution test is used to infer biopharmaceutical properties of the dosage form, it is es-sential that the method simulates the gastrointestinal conditions. The objective of this study was to examine the applicabil-ity of different dissolution media to the evaluation of ABZ and ABZ-SD dissolution rates. Dissolution profiles were performed by the official method (0.1 N HCl) and Simulated Gastric Fluid modified with a surfactant. Wetting was evaluated through the determination of surface tension and contact angle of the solutions. The dissolution rate of ABZ was clearly affected by the variables assessed in this study. These results have implications in the design of physiologically based dissolution media.Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; ArgentinaFil: Castro, Silvina Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Sanchez Bruni, Sergio Fabian. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatología. Laboratorio de Farmacología; ArgentinaFil: Allemandi, Daniel Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentin

Dissolution Stability study of Cefadroxil extemporaneous suspensions

Dissolution studies have become matter of great significance because, in most cases, drug dissolution is the rate-limiting step in the absorption process. As occurs with solid oral dosage forms, heterogeneous disperse systems (suspensions) could also have some problems with their in vitro dissolution. The dissolution behavior of four different brands of cefadroxil extemporaneous suspensions available in the Argentinian market was evaluated. The deliverable volume, pH, visual appearance, uniformity of dosage units, and assay were also studied. Powders for oral suspension were stored under different aging conditions. Samples at room temperature and refrigerated conditions were taken at several time points to carry out the dissolution stability study during the expiration period of the reconstituted form. Marked differences were recorded with respect to in vitro dissolution behavior between the different products under evaluation.Fil: González Vidal, Noelia Luján. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; ArgentinaFil: Zubata, P. D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Simionato, Laura Daniela. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; Argentin