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Objetivos: Determinar la calidad microbiológica de una muestra de productos naturales procesados de uso medicinal de libre comercio en Quito, Ecuador. Materiales y métodos: 83 productos se sometieron a recuentos de microorganismos aerobios, mohos y levaduras por técnicas convencionales estandarizadas, de acuerdo a la Farmacopea de los Estados Unidos (USP, por sus siglas en inglés). Se identificaron los microorganismos presentes y se determinó su sensibilidad antimicrobiana usando el método de difusión en agar. Resultados: El 17,0% de los jarabes, el 27,0% de los productos tópicos y el 43,0% de los sólidos orales excedieron los límites especificados para el recuento total de microorganismos aerobios, mientras que el 33,0% de los jarabes, el 7,0% de los productos tópicos y el 36,0% de los sólidos orales excedieron el límite para mohos y levaduras. Los productos de uso ocular no pasaron la prueba de esterilidad. El género bacteriano más frecuentemente aislado fue Bacillus, seguido por Escherichia coli, Klebsiella y Enterobacter. Salmonella ni Staphylococcus aureus se encontraron en ningún producto, pero microorganismos potencialmente patógenos como Pseudomonas se aislaron en el 40,0% de los colirios. Enterobacter y Escherichia coli mostraron resistencia a múltiples compuestos y Pseudomonas no fue resistente a ningún antibiótico. Conclusiones: La calidad microbiológica de los productos examinados no fue adecuada. Se aislaron microorganismos potencialmente patógenos y resistentes a antibióticos. Estos productos podrían no ser aptos para su distribución y consumo, aun cuando muchos de ellos cuenten con registro sanitario. El control y regulación por los entes responsables es indispensable.

There are many natural sources to obtain pharmaceutical grade starch, one of which is banana (Musa × paradisiaca L.); nevertheless, the use of native starch has certain disadvantages compared to modified starches, whose disintegrating properties are better. In this study, starch extracted from rejected fruits of Musa × paradisiaca L., was modified by acetylation, under the following optimized experimental conditions: 130 mL acetic anhydride, 3 mL sodium hydroxide 50% p/v for each 15 grams of native starch, at 123℃ during 3 hours. The reaction resulted in a modified green banana starch with twice as much swelling capacity compared to unmodified (native) starch; acetylation was verified by infrared spectroscopy and degree of substitution of acetyl groups by back titration. The dissolution profiles of Ibuprofen tablets made with banana modified starch and commercial disintegrant, have no differences according with their similarity factor, f2. It is concluded that it is feasible to use green banana starch modified through acetylation as a pharmaceutical disintegrant.

This work focuses on the search and development of drugs that may become new alternatives to the commercial drugs currently available for treatment of leishmaniasis. We have designed and synthesized 12 derivatives of bis(spiropyrazolone)cyclopropanes. We then characterized their potential application in therapeutic use. For this, the in vitro biological activities against three eukaryotic models—S. cerevisiae, five cancer cell lines, and the parasite L. mexicana—were evaluated. In addition, cytotoxicity against non-cancerous mammalian cells has been evaluated and other properties of interest have been characterized, such as genotoxicity, antioxidant properties and, in silico predictive adsorption, distribution, metabolism, and excretion (ADME). The results that we present here represent a first screening, indicating two derivatives of bis(spiropyrazolone)cyclopropanes as good candidates for the treatment of leishmaniasis. They have good specificity against parasites with respect to mammalian cells.

Excipients represent the complement of the active principle in any pharmaceutical form. Their function is to provide stability, protection, and to ensure absorption of the drug and acceptability in patients. Cellulose is a conventional excipient in many pharmaceutical solid dosage products. Most of the sources used to extract microcrystalline cellulose come from cotton or wood, which are expensive and in high demand from other industries. As plants are considered the main source of excipient production, we have taken advantage of the biodiversity of Ecuador to evaluate microcrystalline cellulose extracted from boroj&oacute, (Alibertia patinoi), a native plant, as an excipient for solid dosage formulations. The method of choice for tablet manufacturing was direct compression since it is a conventional fabrication method in the pharmaceutical industry. First, we performed scanning electron microscopy (SEM), Fourier-transform infrared (FTIR) spectroscopy, and X-ray diffraction (XRD) in order to compare the structure and characteristics of the extracted cellulose with two reference commercial cellulose materials. Second, we performed quality tests to evaluate the use of the isolate as an excipient including fluidity, hardness, friability, and disintegration. Compared with commercial and microcrystalline cellulose, the extracted cellulose from the native plant showed comparable characteristics and is consequently a potential excipient that could be used in the pharmaceutical industry. Last, we performed a dissolution test in which we concluded that all tablets have a short release time of active principle.

To determine the microbiological quality of samples from processed natural products used for medicinal purposes and marketed in Quito, Ecuador.Aerobic microorganisms, molds and yeasts were counted by conventional standardized techniques, according to the United States Pharmacopoeia (USP), in samples from 83 products. The microorganisms found were identified and their antimicrobial sensitivity was determined using the agar diffusion method.The total aerobic microorganism count exceeded the specified limits in 17.0% of syrups, 27.0% of topical products and 43.0% of oral solids; the molds and yeasts count exceeded the limit in 33.0% of syrups, 7.0% of topical products and 36.0% of oral solids. Products for eye use did not pass the sterility test. The most frequently isolated bacterial genus was Bacillus, followed by Escherichia coli, Klebsiella and Enterobacter. Salmonella and Staphylococcus aureus were not found in any product, but potentially pathogenic microorganisms such as Pseudomonas were isolated in 40.0% of the eye drops. Enterobacter and Escherichia coli showed resistance to multiple compounds and Pseudomonas was not resistant to any antibiotic.The microbiological quality of the products examined was not adequate. Potentially pathogenic and antibiotic resistant microorganisms were isolated from the samples. These products may not be suitable for distribution and consumption, even though many of them have sanitary registration. Control and regulation by the corresponding authorities is essential.Determinar la calidad microbiológica de una muestra de productos naturales procesados de uso medicinal de libre comercio en Quito, Ecuador.83 productos se sometieron a recuentos de microorganismos aerobios, mohos y levaduras por técnicas convencionales estandarizadas, de acuerdo a la Farmacopea de los Estados Unidos (USP, por sus siglas en inglés). Se identificaron los microorganismos presentes y se determinó su sensibilidad antimicrobiana usando el método de difusión en agar.El 17,0% de los jarabes, el 27,0% de los productos tópicos y el 43,0% de los sólidos orales excedieron los límites especificados para el recuento total de microorganismos aerobios, mientras que el 33,0% de los jarabes, el 7,0% de los productos tópicos y el 36,0% de los sólidos orales excedieron el límite para mohos y levaduras. Los productos de uso ocular no pasaron la prueba de esterilidad. El género bacteriano más frecuentemente aislado fue Bacillus, seguido por Escherichia coli, Klebsiella y Enterobacter. Salmonella ni Staphylococcus aureus se encontraron en ningún producto, pero microorganismos potencialmente patógenos como Pseudomonas se aislaron en el 40,0% de los colirios. Enterobacter y Escherichia coli mostraron resistencia a múltiples compuestos y Pseudomonas no fue resistente a ningún antibiótico.La calidad microbiológica de los productos examinados no fue adecuada. Se aislaron microorganismos potencialmente patógenos y resistentes a antibióticos. Estos productos podrían no ser aptos para su distribución y consumo, aun cuando muchos de ellos cuenten con registro sanitario. El control y regulación por los entes responsables es indispensable.

Long-term stability studies of pharmaceutical forms require a large amount of resources and time for their development.Alternatively, more efficient methods have been proposed, among these, the paradigm of isothermal isoconversionis highlighted to estimate the useful life in a few weeks. This approach recognizes pharmaceutical formsas heterogeneous systems without a single kinetic order, it establishes a maximum percentage of degradation andassumes the same kinetics for all degradation processes independently of the conditions in which they are carriedout, and it also includes in the calculations the effect of humidity through a modification to the Arrhenius equation.The objective of the present investigation was to apply the isothermal isoconversion in order to estimate the shelf-lifeof the acetylsalicylic acid tablets in few weeks. Six combinations of humidity and temperature were used to establishthe necessary time for the formation of 0.15% salicylic acid, being calculate activation energy too, the MonteCarlo method was applied with 5000 simulations considering values of temperature and relative humidity within acertain range. The estimated shelf-life life for raw material was 415.5 days and 35.6 days for tablets. This methoddemonstrates in a short time the impact of the excipients and the manufacturing process on the stability of a drug. Los estudios tradicionales de estabilidad son excesivamente largos y costosos. Alternativamente, se han propuestométodos más eficientes, entre los que se destaca aquel que usa el paradigma de isoconversión isotérmica paraestimar la vida útil en unas pocas semanas, con un importante ahorro de recursos. Este enfoque reconoce a lasformas farmacéuticas como sistemas heterogéneos sin un orden cinético único, establece un porcentaje máximode degradación y asume una misma cinética para todos los procesos de degradación independientemente de lascondiciones en las que se lleven a cabo, además incluye en los cálculos el efecto de la humedad mediante unamodificación a la ecuación de Arrhenius. El objetivo del presente trabajo fue aplicar la isoconversión isotermala fin de estimar en pocas semanas la vida útil de comprimidos de Ácido acetilsalicílico. Se realizaron pruebasexperimentales para evaluar la eficacia de la isoconversión en la estabilidad del fármaco, incluyendo seis combinacionesde humedad y temperatura para establecer el tiempo necesario para la formación del 0,15 % de ácidosalicílico y se calculó la Energía de activación, se aplicó el método de Monte Carlo con 5000 simulaciones queconsideran valores de temperatura y humedad relativa dentro de un rango determinado. La vida útil estimada fue415,5 días para materia prima y 35,6 días para comprimidos. Este método permite evidenciar en corto tiempo elimpacto de los excipientes y el proceso de manufactura en la estabilidad de un medicamento

Many drugs are administered in the form of liquid-dispersed nanoparticles. Frequently, one of the overlooked aspects in the development of this drug delivery system is the loss of efficacy and the degradation of the carried drugs. Estimating the shelf life of drug products implies the storage of samples under controlled conditions of temperature and humidity for different periods, ranging from months to years, delaying decisions during development, manufacturing, and commercialization. Adapting well-known isothermal and nonisothermal methods to nanoparticles would allow correlating kinetic parameters obtained in a single mathematical model and predicting the shelf life faster than traditional methods. Unlike the traditional approaches, the isoconversional method (i) considers drug products as heterogeneous systems, without a unique kinetic order, (ii) establishes a maximum percentage of degradation, (iii) assumes the same kinetics for all processes regardless of the conditions, and (iv) includes the influence of humidity by a modification of Arrhenius equation. This method serves in calculating the kinetic parameters and shelf life derived from them, in a few weeks. In the same way, nonisothermal treatments allow obtaining these parameters by differential scanning calorimetry. Samples are subjected to different heating rates to establish the temperature at which the thermal decomposition event occurs and, thus, to calculate in a few days the activation energy and the preexponential factor using the Kissinger method. But this approach has limitations: the isoconversional method does not consider crystalline state of the sample, while nonisothermal method ignores the effect of the storage conditions. Processing nanoparticles for isothermal and nonisothermal treatments would allow accurate and fast prediction of the drug-loaded nanoparticle shelf life correlating parameters obtained using a single mathematical model. The accuracy of the prediction would be assessed by comparison of estimated shelf life versus data coming from traditional stability studies.

The documentary conservation in recent years plays an important role in society, because it tries to recover thehistorical memory, and the documentary acquis of it. One of the most prevalent and difficult problems is theexistence of fungi and its metabolic products in documents, as it potentially causes a total loss of information,hindering the restoring process as well. The study seeks to formulate a solution to treat this fungal contamination,using Fluconazole as an antifungal. We started by isolating fungi found in the books, followed by the useof the pseudo-ternary diagram for the formulation of the solution of Fluconazole, and finally the effectivenessof this formulations was evaluated by using modified microbiological techniques, obtaining a percentagereduction on CFU of 90%, by nebulization a solution of Fluconazole at 24% and co-solvents: Water: 20%,Methanol: 50%, Ethanol: 30%, during 15 minutes. La conservación documental en los últimos años cumple un rol importante en la sociedad, debido a que trata derecuperar la memoria histórica y el acervo documental de la misma. Uno de los problemas de mayor incidencia ydificultad es la presencia de hongos y sus productos metabólicos en los documentos, ya que potencialmente ocasionanla pérdida total de la información dificultando de esta forma los procesos de restauración. El presente estudio buscaformular una solución para tratar esta contaminación de hongos, con el uso de fluconazol como agente antifúngico. Seinició aislando los hongos presentes en los libros, seguido del uso del Diagrama pseudoternario para la formulaciónde la solución de Fluconazol, y por último, se evaluó la eficacia de esta formulación por técnicas microbiológicasmodificadas, obteniéndose de esta manera, una reducción porcentual de Unidades Formadoras de Colonias de hongosmayor al 90%, mediante la nebulización de una solución de Fluconazol al 24% compuesta por una mezcla decosolventes: Agua: 20%, Metanol: 50%, Etanol: 30%, con un tiempo de aplicación de 15 minutos.