Aportaciones a la tecnología del vidrio para inyectables : dimensiones y fuerza de ruptura de las ampollas

Tesi de Llicenciatura per a la obtenció del Grau de Farmàcia. Facultat de Farmàcia. Universitat de Barcelona. Director: Josep Cemeli Pons, José María Suñé Arbussà. 1984

Aportación al estudio de las ampollas de fácil ruptura de uso farmacéutico: ensayo de fuerza de ruptura

[spa] Se realiza un amplio estudio experimental con el fin de mejorar el ensayo de control de calidad de la fácil ruptura de las ampollas de uso farmacéutico que presentan esta característica, aplicando una nueva metodología e instrumentación. Esta nueva técnica de ensayo, ya propuesta en la tesina de grado, se perfecciona estudiando las variables inherentes al método que puedan influir en la obtención de los valores de fuerza de ruptura, determinándose las condiciones óptimas de ensayo que lo hagan fácilmente reproducible y objetivo proponiéndose una normativa definitiva que lo estandariza. Con el fin de demostrar la mejora que comporta la metodología original que se propone, se comparan los resultados obtenidos con los que se hallan utilizando el método de Simoncini, que es el más empleado por la industria farmacéutica y los fabricantes de ampollas. Por otro lado, se profundiza en el estudio de aquellas variables inherentes a la ampolla de fácil ruptura que, en principio, pudieran influir sobre su correcta o incorrecta apertura, considerando sobre los distintos sistemas de fácil ruptura existentes en el mercado. Se utiliza para la realización de los ensayos un dinamómetro electrónico J.J. Lloyd Instruments al que se acoplan dos mordazas, una superior y otra inferior, de diseño propio (totalmente original) y fabricados en acero. Empleando ampollas procedentes de 6 fabricantes distintos se ensayan series de 100 ampollas por lote, realizándose las siguientes observaciones: fuerza de ruptura (N), tipo de rotura y estado final de la ampolla. Consta el trabajo de 7 grandes apartados experimentales, en cada uno de los cuales se realiza el estudio estadístico pertinente y correspondientes representaciones gráficas obtenidas en el registrador grafico que se dispone acoplado al dinamómetro electrónico que se emplea

Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results

Objectives: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. Methods and Findings: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved), negative (when no statistical significance was achieved or it favored control drug) and descriptive (for non-controlled studies). Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785). Study results were identified for 68·9% of all completed clinical trials (541/785). Publication rate was 84·9% (180/212) for studies with results classified as positive and 68·9% (128/186) for studies with results classified as negative (p<0·001). Median time to publication was 2·09 years (IC95 1·61-2·56) for studies with results classified as positive and 3·21 years (IC95 2·69-3·70) for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55). No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409) and negative result studies (median 8·266, interquartile range: 4·135-17·157). Conclusions: Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results. However, no differences have been found in terms of impact factor

Food and Sports Nutrition Trends

This revision intends to provide an overview on the major and emerging trends in food and nutrition. Food scientists and dietitians should keep an eye on the trends shaping the food industry in order to understand consumer changes in preferences, expectations and dietary patterns; and to identify those areas that should be added to the research agenda. In addition, to comprehend the major drivers of change in the food industry, global consumer trends are also reviewed in this article. Global concerns are shaping consumer attitudes, and with an easier access to information and an unprecedented consumer power through social media, the food industry should quickly adapt to meet consumer needs. In order to meet these objectives, this review is organized in three different but interrelated sections: global consumer trends, food and nutrition trends, and trends in sports foods and nutrition. This last one is also included due to its influence over food trends, and its significant relevance as a category and food trend

Innovative Therapeutic and Delivery Approaches Using Nanotechnology to Correct Splicing Defects Underlying Disease

Alternative splicing of pre-mRNA contributes strongly to the diversity of cell- and tissue-specific protein expression patterns. Global transcriptome analyses have suggested that >90% of human multiexon genes are alternatively spliced. Alterations in the splicing process cause missplicing events that lead to genetic diseases and pathologies, including various neurological disorders, cancers, and muscular dystrophies. In recent decades, research has helped to elucidate the mechanisms regulating alternative splicing and, in some cases, to reveal how dysregulation of these mechanisms leads to disease. The resulting knowledge has enabled the design of novel therapeutic strategies for correction of splicing-derived pathologies. In this review, we focus primarily on therapeutic approaches targeting splicing, and we highlight nanotechnology-based gene delivery applications that address the challenges and barriers facing nucleic acid-based therapeutics

Evaluación del programa multimedia: fabricación de comprimidos de paracetamol

Se hace un estudio de los resultados obtenidos con las diferentes evaluaciones a que se somete a los alumnos que se forman con un programa multimedia (desarrollado por los autores, figura 1) sobre una temática de tecnología farmacéutica: fabricación de comprimidos de paracetamol. El programa consta de 4 unidades didácticas (ver tabla 1) que han sido introducidas en el aula informática progresivamente, lo cual ha permitido desarrollar pruebas piloto que han mejorado el producto final. En este estudio se hace un resumen de la progresión y de los resultados que han ido obteniendo los alumnos durante los tres cursos académicos en que se ha utilizado como material docente. En este momento (primer cuatrimestre del 2002) se está utilizando el programa completo (versión beta) como prueba piloto, para obtener la versión definitiva, para todos los alumnos de la asignatura obligatoria Farmacia Galénica II, éstos resultados se compararán con los obtenidos en cursos anteriore

Phytosterol determination in lipid emulsions for parenteral nutrition

Objective: The presence of phytosterols in vegetal lipid emulsions has been associated with alterations of liver function tests. Determination of phytosterols content, currently undeclared, would allow the development of strategies to prevent or treat these alterations. Method: 3-4 non-consecutive batches of 6 lipid emulsions from diffe rent providers (Clinoleic , Intralipid , Lipofundina , Lipoplus , Omegaven and Smoflipid ) were analyzed. Differences in total phytosterol assay between providers and batches were statistically studied by a one way ANOVA and Kruskal-Wallis non-parametric approximation and post hoc Scheffé test (p<0.05) Results: The absence of phytosterols was confirmed in Omegaven , emulsion based on fish oil. The highest assay of phytosterols (422.4±130.5 µg/mL) has been related with the highest percentage of soya bean oil in Intralipid. In the remaining emulsions, concentrations were from 120 to 210 µg/mL related to the percentage of soya bean oil. Statistically significant differences of phytosterol content in lipid emulsions were observed among different providers (F=23.59; p=0.000) as well as among non-consecutive batches. Clinolenic (F=23.59; p=0.000), Intralipid (F=978.25; p=0.000), Lipofundina TCL/TCM (F=5.43; p=0.045), Lipoplus (F=123.53; p=0.000) and Smoflipid (16.78; p=0.000). Except for Lipofundina TCL/TCM, the differences between batches were marked. Conclusions: Lipid emulsions, registered on Spanish pharmaceutical market, contain variable quantities of phytosterols dependent on commer cial brand and batch

Metodologia innovadora per fomentar l'aprenentatge de competències transversals durant les pràctiques de l'especialitat farmàcia galènica i industrial (TEFIG): optimització d'una formulació farmacèutica comercialitzada

Aquest treball forma part dels projectes 2013PID-UB/009 i 2014PID-UB/050En aquest treball s'explicarà una metodologia innovadora per tal de promoure les competències d'iniciativa, creativitat, treball en equip, presa de decisió i autosuficiència dels alumnes del Títol d'Especialista en Farmàcia Industrial i Galènica(TEFIG). L'objectiu va consistir en millorar les característiques reològiques d'una premescla medicamentosa, fent ells la recerca bibliogràfica, desenvolupant les formulacions i fent la fabricació, valorant després l'assoliment de l'objectiu

SeDeM as a Tool to Validate Drug Substance Manufacturing Processes and Assess Scalability and Suitability for Direct Compression: Supplier Screening

During the development of an oral solid form of a drug substance, a thorough understanding of the critical material attributes is necessary, as the physical properties of the active pharmaceutical ingredient (API) can profoundly influence the drug product's manufacturability, critical quality attributes, and bioavailability. The objective of this study was to validate the manufacturing process of the drug Linezolid from three different sources at both the pilot and industrial scale and to identify differences in critical material attributes between the API manufacturers. Furthermore, the scalability factor between the pilot and industrial scale and the suitability of a process for direct compression were also evaluated. In the present study, the different sources of API were characterized by SeDeM methodology, particle size distribution, and scanning electron microscopy determinations. The statistical analysis revealed that no statistically significant differences were found for any of the parameters under study for the same API source analyzed on both scales. On the other hand, for most of the parameters evaluated, statistical differences were observed between the different sources. It was concluded that SeDeM was able to successfully validate the API manufacturing process, assess scalability, and distinguish between sources. Therefore, it could be highly valuable in the formulation phase to select the best API source. Keywords: Linezolid; SeDeM expert system; critical material attribute; critical quality attribute; direct compression; drug substance manufacturers; particle size; powder characterization; preformulation; process validation

Authentication of gold nanoparticle encoded pharmaceutical tablets using polarimetric signatures

The counterfeiting of pharmaceutical products represents concerns for both industry and the safety of the general public. Falsification produces losses to companies and poses health risks for patients. In order to detect fake pharmaceutical tablets, we propose producing film-coated tablets with gold nanoparticle encoding. These coated tablets contain unique polarimetric signatures. We present experiments to show that ellipsometric optical techniques, in combination with machine learning algorithms, can be used to distinguish genuine and fake samples. To the best of our knowledge, this is the first report using gold nanoparticles encoded with optical polarimetric classifiers to prevent the counterfeiting of pharmaceutical products