Novel Organogels from Mauritia flexuosa L.f and Caryodendron orinocense Karst.: A Topical Alternative.

Organogels have importance for topical applications because they can be used to deliver drugs in a controlled and prolonged fashion. These are materials consisting of a three-dimensional network of organic molecules dispersed in a solvent. Recent studies have demonstrated that the solvent could be replaced by oils from non-conventional biologic sources. There is a diversity of not-explored species in the Amazon that are promising sources of vegetable oils with a promising composition. This study developed an organogel with buriti (Mauritia flexuosa L.f) and cacay (Caryodendron orinocense Karst.) oils, using cetostearyl alcohol as an organogelator due to its compatibility, stability, security, affordability, and it is readily available. The oils were characterized, and the organogels were synthesized by studying their crystal evolution and oil-binding capacity. The microstructure was evaluated with polarized light microscopy, fractal dimension, FTIR spectroscopy, XRD, and thermal and rheological analyses. It was found that the critical gelation concentration was higher for cacay oil as it possessed a higher amount of polyunsaturated triacylglycerols. The crystals of the buriti organogel had a smaller lamellar shape, a greater surface area, and physical and thermal stability; although, it presented a slower crystal evolution due to the low number of minor compounds and a greater number of saturated triacylglycerols. The polar fraction of the organogelators as well as triacylglycerol and minor polar compounds are important in forming crystallization nuclei. The study showed that Amazonian oils in crystallization processes form microstructures with differentiating physicochemical properties.

New concepts for transdermal delivery of oxygen based on catalase biochemical reactions studied by oxygen electrode amperometry.

The development of formulation concepts for improved skin tissue oxygenation, including methods for measuring oxygen (O2) transport across biological barriers, are important research topics with respect to all processes that are affected by the O2 concentration, such as radiation therapy in oncology treatments, wound healing, and the general health status of skin. In this work we approach this topic by a novel strategy based on the antioxidative enzyme catalase, which is naturally present in the skin organ where it enables conversion of the reactive oxygen species hydrogen peroxide (H2O2) into O2. We introduce various applications of the skin covered oxygen electrode (SCOE) as an in-vitro tool for studies of catalase activity and function. The SCOE is constructed by placing an excised skin membrane directly on an O2 electrode and the methodology is based on measurements of the electrical current generated by reduction of O2 as a function of time (i.e. chronoamperometry). The results confirm that a high amount of native catalase is present in the skin organ, even in the outermost stratum corneum (SC) barrier, and we conclude that excised pig skin (irrespective of freeze-thaw treatment) represents a valid model for ex vivo human skin for studying catalase function by the SCOE setup. The activity of native catalase in skin is sufficient to generate considerable amounts of O2 by conversion from H2O2 and proof-of-concept is presented for catalase-based transdermal O2 delivery from topical formulations containing H2O2. In addition, we show that this concept can be further improved by topical application of external catalase on the skin surface, which enables transdermal O2 delivery from 50 times lower concentrations of H2O2. These important results are promising for development of novel topical or transdermal formulations containing low and safe concentrations of H2O2 for skin tissue oxygenation. Further, our results indicate that the O2 production by catalase, derived from topically applied S. epidermidis (a simple model for skin microbiota) is relatively low as compared to the O2 produced by the catalase naturally present in skin. Still, the catalase activity derived from S. epidermidis is measurable. Taken together, this work illustrates the benefits and versatility of the SCOE as an in vitro skin research tool and introduces new and promising strategies for transdermal oxygen delivery, with simultaneous detoxification of H2O2, based on native or topically applied catalase.

The Effect of UVB Irradiation and Oxidative Stress on the Skin Barrier-A New Method to Evaluate Sun Protection Factor Based on Electrical Impedance Spectroscopy.

Sunlight is vital for several biochemical processes of the skin organ. However, acute or chronic exposure to ultraviolet radiation (UVR) has several harmful effects on the skin structure and function, especially in the case of the failing function of antioxidative enzymes, which may lead to substantial tissue damage due to the increased presence of reactive oxygen species (ROS). The aim of this work was to investigate the combined effect of ultraviolet B (UVB) irradiation and oxidative stress on the skin barrier integrity. For this, we employed electrical impedance spectroscopy (EIS) to characterize changes of the electrical properties of excised pig skin membranes after various exposure conditions of UVB irradiation, oxidative stress, and the inhibition of antioxidative enzymatic processes. The oxidative stress was regulated by adding hydrogen peroxide (H2O2) as a source of ROS, while sodium azide (NaN3) was used as an inhibitor of the antioxidative enzyme catalase, which is naturally present throughout the epidermis. By screening for the combined effect of UVB and oxidative stress on the skin membrane electrical properties, we developed a new protocol for evaluating these parameters in a simple in vitro setup. Strikingly, the results show that exposure to extreme UVB irradiation does not affect the skin membrane resistance, implying that the skin barrier remains macroscopically intact. Likewise, exposure to only oxidative stress conditions, without UVB irradiation, does not affect the skin membrane resistance. In contrast to these observations, the combination of UVB irradiation and oxidative stress conditions results in a drastic decrease of the skin membrane resistance, indicating that the integrity of the skin barrier is compromised. Further, the skin membrane effective capacitance remained more or less unaffected by UVB exposure, irrespective of simultaneous exposure of oxidative stress. The EIS results were concluded to be associated with clear signs of macroscopic tissue damage of the epidermis as visualized with microscopy after exposure to UVB irradiation under oxidative stress conditions. Finally, the novel methodology was tested by performing an assessment of cosmetic sunscreen formulations with varying sun protection factor (SPF), with an overall successful outcome, showing good correlation between SPF value and protection capacity in terms of skin resistance change. The results from this study allow for the development of new skin sensors based on EIS for the detection of skin tissue damage from exposure to UVB irradiation and oxidative stress and provide a new, more comprehensive methodology, taking into account both the influence of UVB irradiation and oxidative stress, for in vitro determination of SPF in cosmetic formulations.

Desarrollo y validación de una metodología analítica por HPLC-DAD para la cuantificación de Warfarina Sódica en una preparación extemporánea / Development and validation of an analytical method by HPLC-DAD for quantification of Warfarin Sodium in an extemporaneous preparation

En este trabajo se llevó a cabo el desarrollo y la validación de una metodología analítica por HPLC para la cuantificación de Warfarina Sódica en una suspensión para uso hospitalario. La selectividad se evaluó frente a los excipientes y compuestos de degradación; la linealidad en el rango de concentraciones comprendido entre 0,05 y 0,15 mg/mL; la precisión se estudió en los niveles de repetibilidad y precisión intermedia y la exactitud en tres niveles de concentración que corresponden al 75%, 100% y 125%. Los resultados muestran que la validación de la metodología por HPLC es selectiva, lineal, precisa y exacta; por tanto, es confiable para ser utilizada en la cuantificación del activo Warfarina Sódica en una suspensión extemporánea y también en estudios de estabilidad de dicha preparación.

In this work was carried out the development and quantification of an analytical methodology for quantification of Warfarin Sodium in an extemporaneous suspension for hospital use. Evaluation of specificity was achieved against its excipients and degradation compounds. The selectivity was evaluated against the excipients and degradation compounds. Linearity studies were performed in a range of concentration between 0.05 to 0.15 mg/mL. Precision was evaluated in levels of repeatability and intermediate precision and accuracy in three concentration levels corresponding to the 75, 100 and 125%. The results show that the validation of the methodology is selective, linear, accurate and precise; therefore, it is reliable for use in the quantification of active warfarin sodium in the extemporaneous suspension.

In vitro analysis regarding the safety of components used in a film-based therapeutic system loaded with meglumine antimoniate and its activity toward Leishmania major experimental infections: a preliminary study.

Owing to its biocompatibility properties and its ability to promote the scar healing process, chitosan is employed in tissue engineering for the manufacture of formulations. To control the characteristic skin ulcers of cutaneous leishmaniasis (CL), the use of a biopolymeric system that favors the scar healing process and releases an active agent such as meglumine antimoniate may be a better option. For these reasons, here we analyzed the cytotoxic capabilities of excipients [medium molecular weight chitosan (MMWC), lactic acid (LA) and polyvinylpyrrolidone (PVP)], used for the formulation of a film-based therapeutic system that releases meglumine antimoniate and were evaluated on human macrophages [monocyte-derived macrophages (MDMs)], L929 fibroblasts and parasites (Leishmania major promastigotes and intracellular amastigotes). The ability of excipients to modulate the cytokines production involved in the scar healing process was compared with film-based therapeutic system. The efficiency of a film-based therapeutic system loaded with meglumine antimoniate was compared with conventional formulation (Albiventriz(®)). We found that MMWC was toxic for two parasite forms. In contrast, measurement of interleukin levels did not show any evidence of preferential secretion as a side effect of treating human macrophages with MMWC. Finally, the efficiency of a polymeric film-based therapeutic system that was loaded with meglumine antimoniate could not be determined due to the high degree of toxicity observed in infected MDMs; moreover, these compounds do not induce any apparent immunomodulatory effects. Our findings suggest that the final concentrations of each excipients (MMWC, LA and PVP) that were used in the polymeric film were suitable vehicles for active pharmaceutical compound delivery and did not selectively affect (enhancing or diminishing immune activity) macrophages.

Estudio descriptivo de los operadores logísticos como componentes estratégicos dentro de la cadena de valor del medicamento en Bogotá / Descriptive study about logistic operators as strategic compounds within the chain value of the drugs in Bogota

El operador logístico (ol) es una organización del sector industrial que realiza actividades complementarias como distribución, almacenamiento y transporte tanto de materias primas como de producto terminado, y su participación es cada vez más frecuente en el manejo de medicamentos, donde eventualmente pudiera verse afectada la calidad del producto. En este estudio se identificaron 75 ol localizados en la ciudad de Bogotá y se caracterizaron de acuerdo con las actividades que realizan, con el fin de determinar su importancia dentro de la cadena de valor del medicamento (cvm). Se encontró que no existen políticas exclusivas para los ol en la legislación colombiana, aunque éstos deben cumplir la normatividad existente para la manipulación de los medicamentos. En el estudio se diseñó y se desafió con el ol del sector, un instrumento especializado para capturar información que puede ser empleado en la caracterización de estas empresas en futuras investigaciones. También se identificaron nuevos servicios que los operadores ofrecen a la industria farmacéutica, corroborando el hecho de que estas organizaciones han alcanzado un importante grado de intervención sobre la cvm, especialmente conectando los eslabones productorcliente y planteando un desafío para el profesional farmacéutico en áreas alternativas de su ejercicio profesional.

The Logistic Operator (lo) is a type of industrial organization that does complementary activities such as distribution, storage and transportation, as well as, raw materials and finished products. Their interference is frequently involved in the handling of drugs and exist the risk that the quality of the drug can be affected by their participation. In this study were identified and characterized 75 (lo) located in Bogota city according to the activities that they perform, with the intention to determine their importance within the chain value of the drug (cvd). We found that don’t exist exclusive policy for lo in the Colombian legislation although they must comply with the regulations referred to handling of medicines. In this study was designed and challenged in lo of the sector, a specific document to capture information that can be use in order to get the activities of characterization in future research. Also were identified new services for the pharmaceutical industry, it was demonstrated that the (lo) possess a high degree of intervention on the cvd connecting the producer-customer links and this result expound a challenge for the pharmacist in other fields of their professional performance.

Aspectos generales de la automatización industrial del sector farmacéutico / General aspects about the industrial automation in pharmaceuticals

El presente artículo recopila la información sobre las tendencias mundiales en automatización de procesos industriales, aplicados al campo de los procesos de transformación de materiales en el sector farmacéutico. Se plantean los diferentes niveles de automatización que pueden ser de interés para la industria farmacéutica nacional y se hace una reflexión sobre el grado de avance para nuestra industria, seleccionando información sobre casos exitosos de automatización llevados a cabo desde la academia para el sector

Evaluación de la velocidad de liberación de un principio activo para acondicionamiento de suelos, desde comprimidos matriciales con base en un hidrogel de acrilamida / Evaluation of the release rate of a soil conditioning compound from acrylamide hydrogel matrixes

Este trabajo evaluó el efecto de la composición de comprimidos matriciales a base de un hidrogel de acrilamida, sobre la funcionalidad de un producto diseñado para el acondicionamiento de pH en suelos. Se llevó a cabo una caracterización farmacotécnica del polímero y se propusieron siete alternativas de composición. En los prototipos obtenidos se evaluó la funcionalidad del prototipo en términos de caracterización del comprimido, cesión del principio activo desde los comprimidos, mantenimiento de forma, cinética de liberación del principio activo y funcionalidad “in vivo”. Se encontró que los atributos del usuario identificados para el producto y expresados en términos de requerimientos funcionales fueron cumplidos en los prototipos ensayados

Estudio descriptivo del sector productor y comercializador de cosméticos en Bogotá D.C. Colombia / Descriptive study of the sector which produces and sells cosmetics in Bogotá D.C. Colombia

Aplicando una metodología de investigación no experimental transeccional descriptiva, se describió al sector que produce y comercializa cosméticos de la ciudad de Bogotá, Colombia, para el segundo semestre de 2004. El modelo empleado contempló tanto el diseño, elaboración y desafío del instrumento de captura de información, como la definición de la población que formó parte del proyecto, cuyo tamaño, después de confirmar la pertenencia al estudio, ameritó continuarlo mediante la técnica del censo poblacional. La encuesta fue diligenciada mediante entrevista al profesional técnico con mayor responsabilidad dentro de la organización o en su defecto por el gerente o su delegado. Además de lograr un acercamiento al sector de cosméticos, el análisis de los resultados obtenidos permitió concluir sobre las características que describen su estado actual, consolidando una base de datos de la población de cosméticos de la ciudad de Bogotá, y la información para posteriores contactos. Se encontró que la población estudiada no ha superado los 50 años desde su fundación, su capital es principalmente nacional, PYMEs, con baja conciencia de agremiación y clientes esencialmente locales. Sólo la mitad de los miembros de la población son productores, con problemas en sus procesos de transformación de materiales