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1.
São Paulo; s.n; s.n; 2022. 221 p. tab, graf.
Thesis in Portuguese | LILACS | ID: biblio-1392194

ABSTRACT

Para que os fármacos possam ser comercializados economicamente, a sua escala de produção deve ser aumentada para atender à demanda do mercado. Atualmente, a maior parte dos fármacos são sintetizados em processos batelada que possuem limitações quanto à eficiência de mistura, temperatura e pressão. O uso de microrreatores surge como alternativa na indústria químico-farmacêutica, aumentando a eficiência dos processos de maneira segura. Ferramentas utilizadas no segmento computacional multidisciplinar teórico, como o DFT (Density Functional Theory), podem prever e compreender o comportamento das reações químicas, podendo ter grande utilidade na síntese de novos fármacos economizando tempo, investimento e reduzindo a geração de resíduos. A diabetes mellitus é uma doença de caráter epidêmico, que a cada ano vem aumentando o número de casos. O emprego de fármacos derivados das glitazonas no tratamento de diabetes mellitus tipo 2 é recomendado devido ao excelente controle glicêmico que esta classe de fármacos oferece. Neste trabalho, foi sintetizada a Rosiglitazona, um fármaco derivado das glitazonas, que auxilia no tratamento da diabetes mellitus tipo 2, sendo estudadas duas rotas de síntese distintas, que foram otimizadas com o intuito de maximizar o rendimento de seus intermediários, obtendo a Rosiglitazona com pureza de cerca de 94%. Foi realizada, para os intermediários, aqui denominados, 1R, 2R2 e 3R2 a síntese one-pot e para os intermediários 1R, 2R1 e 3R2 foi realizada a transposição do processo usual em batelada para fluxo contínuo no microrreator, com rendimentos de até 93%. Com o auxílio da química quântica computacional, a reação de síntese do intermediário 1R, foi elucidada teoricamente e determinadas as grandezas termodinâmicas (ΔH‡, ΔG‡ e ΔS‡) no estado de transição, que foram comparadas com os valores experimentais, sendo constatada uma boa concordância, com desvio máximo de 14%


In order for drugs to be commercialized economically, their production scale must be increased to meet market demand. Currently, most drugs are synthesized in batch processes that have limitations in terms of mixing efficiency, temperature and pressure. The use of microreactors appears as an alternative in the chemical-pharmaceutical industry, increasing the efficiency of the synthesis processes in a safe way. Tools used in the theoretical multidisciplinary computational segment, such as DFT (Density Functional Theory), can predict and understand the behavior of chemical reactions, and can be very useful in the synthesis of new drugs, saving time, investment and reducing waste generation. Diabetes mellitus is an epidemic disease that has been increasing the number of cases every year. The use of drugs derived from glitazones in the treatment of type 2 diabetes mellitus is recommended due to the excellent glycemic control that this class of drugs offers. In this work, Rosiglitazone, a drug derived from glitazones, which helps in the treatment of type 2 diabetes mellitus, was synthesized. Two different synthetic routes were studied and optimized in order to maximize the yield of its intermediates, obtaining Rosiglitazone with purity of about 94%. One-pot synthesis was performed to 1R, 2R2 and 3R2 intermediates, and the transposition from the usual batch process to continuous flow in microreactor was performed to 1R, 2R1 and 3R2 intermediates, with yields of up to 93%. With the aid of computational quantum chemistry, the intermediate 1R synthesis reaction was theoretically elucidated and the thermodynamic properties were determined (ΔH‡, ΔG‡ and ΔS‡) in the transition state, which were compared with the experimental results, obtaining good agreement, with a maximum deviation of 14%


Subject(s)
Pharmaceutical Preparations/supply & distribution , Drug Industry/organization & administration , Rosiglitazone/analysis , Biopharmaceutics/classification , Chemical Reactions , Diabetes Mellitus, Type 2/pathology , Density Functional Theory , Glycemic Control/instrumentation , Investments/classification
2.
Prensa méd. argent ; 107(4): 204-218, 20210000. fig, graf, tab
Article in English | LILACS, BINACIS | ID: biblio-1359441

ABSTRACT

Los biorreactores de sistemas de un solo uso (SUSs), también conocidos como biorreactores desechables, se han convertido en una parte integral de las instalaciones biotecnológicas de fabricación para bioproductos con un mercado potencial que espera una tasa de crecimiento de casi el 15,5% durante el período pronosticado: 2018 a 2023. Los biorreactores SUSs son más seguros, simples y flexibles al compararlos con sus contrapartes, biorreactores de acero inoxidable, por lo que su uso se está incrementando en la industria biofarmacéutica principalmente en la planificación de vías rápidas de proyectos complejos, incluidos los relacionados con la pandemia de SARS-CoV-2. Así, el uso de SUS se ha convertido en una alternativa eficaz para la producción rápida de candidatos a vacunas. Pero algunas desventajas técnicas y operativas aún obstaculizan su uso en todo el mundo. Esta revisión brinda una visión racional del uso, los tipos, los parámetros operativos y las nuevas aplicaciones de los biorreactores SUSs en la industria biofarmacéutica. Asimismo, también se discuten los parámetros apropiados y las limitaciones de este equipo, enfocándose en su uso para la producción de vacunas contra COVID-19


Single-Use-Systems (SUSs) Bioreactors, also known as disposable bioreactors, have become an integral part of biotechnology manufacturing facilities for bioproducts with a potential market expecting a growth rate of nearly 15.5% over the forecast period: 2018 to 2023. SUSs bioreactors are comparatively safe, simple, and flexible than their stainless-steel bioreactors counterparts thus, their usage is being augmented in the biopharmaceutical industry mainly in planning fast tracks of complex projects, including those related to the SARS-CoV-2 pandemic. Thus, the use of SUSs has become an effective alternative for the rapid production of vaccine candidates. However, some technical and operational disadvantages still hamper their worldwide use. This review gives a rational insight into SUSs bioreactors use, types, operational parameters and new applications in the biopharmaceutical industry. Likewise, the appropriate parameters and limitations of this equipment, focusing on its use for vaccine production against COVID-19 are also discussed


Subject(s)
Humans , Biopharmaceutics , Biotechnology , Bioreactors , Industrial Development , Manufacturing and Industrial Facilities , COVID-19 Vaccines/supply & distribution
4.
Rev. cuba. invest. bioméd ; 40(2): e1378, 2021. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1347451

ABSTRACT

La experiencia científica de los últimos meses contra la pandemia de la COVID-19 muestra una celeridad nunca vista, así mismo, es inédita la velocidad en la publicación de los resultados de tales investigaciones. El contexto revela la carrera sostenida que tiene la ciencia contra la expansión de este letal virus. En el presente estudio se documentan evidencias bibliográficas para reconocer a PubMed como uno de los principales recursos de información científica sobre medicina que existen en el mundo. Es una necesidad del gremio científico médico e investigativo en el contexto de la COVID-19 conocer las temáticas que abordan los principales artículos de la base de datos. El objetivo de esta investigación es analizar el comportamiento temático de los artículos publicados por PubMed sobre coronavirus en el primer semestre del año 2020 utilizando como herramienta de análisis al Observatorio Métrico de Coronavirus de la Universidad de Pinar del Río. El interés científico del estudio se concentra en las variables materia, MeSH y palabras clave; las que son analizadas con diferentes técnicas métricas que facilitan la visualización e interpretación de los resultados. Se demostró que PubMed, entre los temas más recurrentes, ha socializado investigaciones en virología, microbiología, farmacéutica, medicina general integral y sus relaciones con la oncología, neurología, pediatría, psicología, psiquiatría, oftalmología, nutrición, telemedicina y dispositivos médicos(AU)


The scientific experience of recent months against the COVID-19 pandemic shows a speed never seen before, likewise, the speed in the publication of the results of such investigations is unprecedented. The context reveals the sustained race in science against the spread of this deadly virus. In this study, bibliographic evidence is documented to recognize PubMed as one of the main sources of scientific information on medicine that exist in the world. In the context of COVID-19, it is a necessity for the scientific, medical and research union to know the issues addressed by the main articles in the database. The objective of this research is to analyze the thematic behavior of the articles published by PubMed on coronavirus in the first half of 2020, using the Coronavirus Metric Observatory of the University of Pinar del Río as an analysis tool. The scientific interest of the study is concentrated in the variables subject, MeSH and keywords; those that are analyzed with different metric techniques that facilitate the visualization and interpretation of the results. It was shown that PubMed, among the most recurrent topics, has socialized research in virology, microbiology, pharmaceuticals, comprehensive general medicine and their relationships with oncology, neurology, pediatrics, psychology, psychiatry, ophthalmology, nutrition, telemedicine and medical devices(AU)


Subject(s)
Humans , Biopharmaceutics , Racial Groups , Nutritional Sciences , COVID-19 , Microbiology
5.
Rev. cientif. cienc. med ; 24(1): 37-42, 2021. ilus.
Article in Spanish | LILACS | ID: biblio-1358879

ABSTRACT

INTRODUCCIÓN: los sistemas intrahospitalarios sobre la distribución de medicamentos comprenden múltiples procesos en cadena, con la participación de diferentes personas por lo que es susceptible a la generación de errores. OBJETIVO: el propósito fue conocer la generación de posibles errores durante el proceso de registro de datos en el sistema intrahospitalario de distribución de medicamentos del Instituto Gastroenterológico Boliviano Japonés de Cochabamba. METODOLOGÍA: estudio observacional, descriptivo y transversal; donde se utilizó una lista de cotejos para la revisión del registro realizado en los formularios: kardex, recetario/recibo y hoja de tratamiento en el servicio de internación, así como también el registro de medicamentos dispensados realizado en el servicio de farmacia. RESULTADOS: en el servicio de internación se identificó errores de omisión en el kardex de tratamiento, específicamente en el registro de la forma farmacéutica: comprimidos y frascos. En el servicio de farmacia también se encontró errores de omisión en el registro de las mismas formas farmacéuticas. En los servicios de internación y farmacia, se encontró errores de comisión con el registro de dosis diferente en los formularios recibo recetario y hoja de tratamiento y de medicamento dispensado respectivamente superior al 30% en todos los casos. CONCLUSIONES: los errores identificados en el servicio de internación fueron errores de registro de tipo omisión y comisión. En el servicio de farmacia, los errores encontrados fueron errores de registro de tipo comisión.


Introduction: the intra-hospital drug distribution system, comprise multiple chain processes, with the participation of different people, which is susceptible to the generation of errors. Objective: the purpose was to know the generation of possible errors during the data registration process in the intra-hospital drug distribution system of the Japanese Bolivian Gastroenterological Institute of Cochabamba. Methodology: observational, descriptive and cross-sectional study; where a checklist was used to review the record made in the forms: kardex, recipe book / receipt and treatment sheet in the hospitalization service, as well as the record of dispensed drugs made in the pharmacy service. Results: in the hospitalization service, errors of omission were identified in the treatment kardex, specifically in the registry of the pharmaceutical form: tablets and bottles. In the pharmacy service, errors of omission were also found in the registry of the same pharmaceutical formulations. In the hospitalization and pharmacy services, commission errors were found with the registration of different doses in the forms of prescription, receipt and treatment sheet and of dispensed medication, respectively, higher than 30% in all cases. Conclusions: the errors identified in the hospitalization service were omission and commission type registry errors. In the pharmacy service, the errors found were commission-type registration errors.


Subject(s)
Pharmacy Service, Hospital , Biopharmaceutics , Dosage
6.
Infectio ; 24(4): 199-200, oct.-dic. 2020.
Article in Spanish | LILACS, COLNAL | ID: biblio-1114868

ABSTRACT

La pandemia de COVID 19, ha puesto de presente la necesidad de contar con políticas de autonomía farmacéutica y biotecnológica para cada país. Esta autonomía es necesaria porque en eventos ocasionados por agentes de riesgo biológico, la afectación masiva de la población mundial hace imposible que se cubran las necesidades para todos los países. Muchos medicamentos de interés en salud pública no son producidos por la industria farmacéutica privada dado que los márgenes de ganancia no son importantes para ellos y se encuentran situaciones de desabastecimiento ante brotes de infecciones inusitados.


The COVID 19 pandemic has highlighted the need for pharmaceutical and biotechnology autonomy policies for each country. This autonomy is necessary because in events caused by biological risk agents, the massive involvement of the world population makes it impossible to cover the needs of all countries. Many drugs of public health interest are not produced by the private pharmaceutical industry because the profit margins are not important for them and there are situations of shortages in the event of outbreaks of unusual infections.


Subject(s)
Humans , Biotechnology , Disease Outbreaks , Drug Industry , Biological Products , Biopharmaceutics , Pharmaceutical Preparations , Public Health/trends , Health Services Needs and Demand
7.
Rev. baiana saúde pública ; 44(1): 22-40, 20200813.
Article in Portuguese | LILACS | ID: biblio-1253105

ABSTRACT

O presente estudo tem como objetivo desenvolver indicadores de estrutura, processo e resultados da assistência farmacêutica (AF) penitenciária e validá-los segundo a forma e conteúdo. Para isso, o desenvolvimento metodológico constituiu-se pela elaboração de um painel de indicadores da AF prisional. A elaboração do instrumento de trabalho e a validação de seu conteúdo e forma foram realizados com a utilização da técnica Delfos. Para a inclusão dos indicadores, foi considerada uma concordância entre os especialistas selecionados de 80,0%. O grupo foi composto por dez farmacêuticos que atuam em áreas ligadas à AF. O primeiro instrumento elaborado e submetido a julgamento contemplava 114 indicadores (52 de estrutura, 49 de processo e 13 de resultado). Foram necessárias três rodadas para definição da estrutura, forma e conteúdo dos indicadores, totalizando 50 indicadores validados (28 de estrutura; 16 de processo e 6 de resultado). Os resultados refletem a opinião de especialistas na área e o consenso obtido, validando os indicadores construídos. O uso da técnica Delfos foi pertinente, pois não há dados históricos relacionados ao tema e a opinião de profundos conhecedores da temática proporciona a construção de uma linha de ação coerente e confiável.


This study seeks to develop indicators of structure, process and outcomes of penitentiary pharmaceutical assistance (PA) and validate them according to form and content. This is a methodological development study consisting of the elaboration of a prison PA indicator panel. The elaboration of the instrument and its content and form validation were performed using the Delphi technique. For the inclusion of the indicators, an agreement among the selected experts of 80.0% was considered. The group was composed of 10 pharmacists that worked in areas related to Pharmaceutical Assistance. The first instrument elaborated and subjected to judgment included 114 indicators (52 structure, 49 process indicators and 13 result indicators). It took three rounds to define the structure, shape and content of the indicators, totaling 50 validated indicators (28 structure, 16 process and 6 result indicators). The results reflect the opinion of experts in the field and the consensus obtained, which validates the indicators built. The use of the Delphi technique was pertinent, since there is no historical data related to the theme and the opinion of deep knowledge of the subject provides the construction of a coherent and reliable line of action.


El presente estudio tuvo como objetivo desarrollar indicadores de estructura, proceso y resultados de la asistencia farmacéutica penitenciaria (AF) y validarlos de acuerdo con forma y contenido. Para ello, como metodología se desarrolló un panel de indicadores de AF de la prisión. La elaboración del instrumento de trabajo y la validación de su contenido y forma se llevaron a cabo utilizando la técnica Dephi. Para la inclusión de los indicadores, se consideró un acuerdo del 80,0% entre los expertos seleccionados. El grupo estaba compuesto por 10 farmacéuticos que trabajan en áreas relacionadas con la AF. El primer instrumento desarrollado y sometido a juicio incluyó 114 indicadores (52 de estructura, 49 de proceso y 13 de resultado). Se necesitaron tres rondas para definir la estructura, la forma y el contenido de los indicadores, totalizando 50 indicadores validados (28 de estructura; 16 de proceso y 6 de resultado). Los resultados reflejan la opinión de expertos en el área y el consenso obtenido, que valida los indicadores construidos. El uso de la técnica Dephi fue pertinente, ya que no hay datos históricos relacionados con el tema y la opinión profundizada de expertos sobre el tema proporciona elaborar una línea de acción coherente y confiable.


Subject(s)
Pharmaceutical Services , Prisons , Biopharmaceutics , Delphi Technique , Validation Study
8.
Vaccimonitor (La Habana, Print) ; 29(1)ene.-abr. 2020. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1094635

ABSTRACT

En este trabajo se presenta la aplicación del Análisis de Componentes Principales, mediante el programa THE UNSCRAMBLER versión 8.0, a los datos registrados en un período de 2 años en la etapa de purificación de una planta de producción de Eritropoyetina Humana Recombinante que está basada en varios pasos cromatográficos, de forma similar a los procesos de purificación de proteínas recombinantes que se utilizan como vacunas preventivas o terapéuticas. Se logró reducir dimensionalidad al obtenerse dos componentes principales que explican el 81 por ciento de la varianza de 18 variables originales relacionadas con cuatro pasos cromatográficos. Como resultado se llegó a definir cuáles son las variables que mayor aporte tienen a la variabilidad del proceso en la etapa de purificación, permitiendo extraer información útil para lograr un mayor entendimiento del proceso y enriquecer las estrategias de control en la planta. Dichos resultados corroboraron experiencias prácticas de especialistas de la planta y permitieron dar recomendaciones a considerar en el plan de verificación continuada del proceso como proponer cinco variables como controles de proceso y tener en cuenta que el rendimiento del segundo paso cromatográfico es el más influyente de los rendimientos considerados en la variabilidad(AU)


This paper presents the application of the Principal Component Analysis, using the program THE UNSCRAMBLER version 8.0, to the data recorded during two years in the purification stage of a Recombinant Human Erythropoietin plant that is based on several chromatographic steps, similar to the purification process of recombinant proteins that are used as preventive or therapeutic vaccines. Dimensionality was reduced by obtaining two main components that explain 81 percent of the variance of 18 original variables related to four chromatographic steps. As a result, it was possible to define which variables have the greatest contribution to the variability of the process in the purification stage, allowing to extract useful information to achieve a greater understanding of the process and enrich the control strategies in the plant. These results corroborated practical experiences of plant specialists and allowed for recommendations to be considered in the continuous verification plan of the process, such as proposing three variables as process controls and taking into account that the performance of the second step is the most influential of the performances considered in the variability(AU)


Subject(s)
Humans , Biological Products/therapeutic use , Chromatography/methods , Principal Component Analysis/methods , Reference Drugs , Biopharmaceutics
9.
Rev. cuba. salud pública ; 46(1): e1941, ene.-mar. 2020. tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1126820

ABSTRACT

Introducción: La evaluación de los factores claves de éxito de la innovación en la industria biotecnológica aplicada a la salud constituye un problema de investigación. Objetivo: Evaluar la innovación en un centro cubano de la biotecnología aplicada a la salud. Métodos: Se aplicó en dos momentos la encuesta de innovación en el Centro de Inmunología Molecular. Los resultados se procesaron con el diagrama de caja, la estadística básica y el análisis de la correlación. Se analizaron artículos científicos que muestran los resultados de la innovación en el centro. Resultados: La encuesta se aplicó en el 2015 y 2018 a 33 miembros del consejo de dirección y a especialistas, identificándose como estrategias genéricas las de innovación, calidad y liderazgo y como objetivos de innovación los de calidad y el mercado. Las fuentes de innovación más importantes se refieren a las actividades de investigación y desarrollo, la producción, la alta dirección y los centros de investigaciones. Los factores que limitan están relacionados con el período largo de rentabilidad de la innovación, el financiamiento y la adquisición de los insumos. Conclusiones: La evaluación de la innovación en el centro de biotecnología corroboró la significación que tiene para la empresa la estrategia de innovación como factor clave, que lo ubica en una posición de excelencia en la industria biofarmacéutica cubana e internacional(AU)


Introduction: The assessment of the key success factors of innovation in the biotechnology industry applied to health constitutes a research problem. Objective: To assess innovation process in a Cuban center of biotechnology applied to health. Methods: It was applied in two moments the survey of innovation in the Molecular Immunology Center. The results were processed by the box plot, basic statistics and analysis of the correlation. Scientific articles that show the results of innovation in the Center were analyzed. Results: The survey was applied in 2015 and 2018 to 33 members of the board of directors and to specialists, and being identified innovation, quality and leadership as generic strategies, and quality and the market as objectives of innovation. The most important sources of innovation referred to the research and development activities, production, top management and research centers. The limiting factors are related to the long term return of innovation, financing, and the acquisition of supplies. Conclusions: The assessment of innovation in the Biotechnology Center corroborated the significance of the innovation strategy for the company as a key factor, which places it in a position of excellence in the Cuban and international biopharmaceutical industry(AU)


Subject(s)
Biopharmaceutics , Biotechnology , Inventions
10.
Con-ciencia (La Paz) ; 8(2): 75-87, 2020. ilus.
Article in Spanish | LILACS, LIBOCS | ID: biblio-1148001

ABSTRACT

INTRODUCCIÓN: los estudios de bioequivalencia demuestran la equivalencia en la calidad biofarmacéutica entre el producto farmacéutico multifuente y el medicamento de referencia, permitiendo el establecimiento de puentes entre las pruebas preclínicas y los ensayos clínicos asociados con el medicamento de referencia. La Metformina clorhidrato es el fármaco de primera elección para el tratamiento de la diabetes mellitus II y pertenece a la clase 3 del sistema de clasificación biofarmacéutica. OBJETIVO: establecer mediante pruebas de disolución in vitro, si 4 productos farmacéuticos multifuentes de liberación inmediata, de administración peroral, con Metformina clorhidrato, comercializados en Bolivia son bioequivalentes en relación con el producto de referencia, a través de un diseño experimental, con significancia estadística. MÉTODO: Se elaboraron perfiles de disolución de cada producto, tomando en cuenta las condiciones del método del ensayo de disolución establecido en la monografía Metformina, tabletas de la USP 39, considerando seis tiempos de muestreo. Se realizó el análisis cinético de los datos de porcentaje disuelto acumulado de los perfiles de disolución versus el tiempo. Se empleó el método de modelo independiente para comparar los perfiles de disolución de los productos a través del cálculo de los factores de diferencia (f1) y de similitud (f2) recomendados para estudios de bioexención por la Organización Mundial de la Salud. RESULTADOS: todos los productos tomados en cuenta en la investigación cumplieron satisfactoriamente los análisis de Control de Calidad. Los resultados del estudio de Bioequivalencia mostraron que existen diferencias estadísticamente significativas entre los productos del estudio. CONCLUSIÓN: en este estudio no se demostró la Bioequivalencia in vitro de los productos B, C, D y E con relación al producto de referencia A, con base en pruebas de disolución in vitro.


INTRODUCTION: bioequivalence studies demonstrate the equivalence in biopharmaceutical quality between the multi-source pharmaceutical product and the reference medicine, allowing the establishment of bridges between preclinical tests and clinical trials associated with the reference medicine. Metformin hydrochloride is the drug of first choice for the diabetes mellitus II treatment and belongs to class 3 of the Biopharmaceutical Classification System. OBJECTIVE: establish by in vitro dissolution tests, whether 4 multisource pharmaceutical products of immediate release and peroral administration, with Metformin hydrochloride, marketed in Bolivia are bioequivalent in relation to the reference product, through an experimental design, with statistical significance. METHOD: dissolution profiles were prepared for each product, taking into account the conditions of the dissolution test method established in the Metformin, tablets monograph of USP 39, considering six sampling times. The kinetic analysis of the accumulated dissolved percentage data of the dissolution profiles versus time was performed. The independent model method was used to compare the dissolution profiles of the products by calculating the difference factor (f1) and similarity factor (f2) recommended for Biowaiver studies, by the World Health Organization. RESULTS: All the products taken into account in the investigation, satisfactorily fulfilled the Quality Control analysis. The results of the Bioequivalence study showed that there are statistically significant differences between the products of the study. CONCLUSION: In this study the in vitro bioequivalence of the products B, C, D and E in relation to the reference product A was not demonstrated, based on in vitro dissolution tests.


Subject(s)
Biopharmaceutics , In Vitro Techniques , Metformin , Quality Control , Research Design , Pharmaceutical Preparations , Diabetes Mellitus , Dissolution , Methods
11.
Braz. J. Pharm. Sci. (Online) ; 56: e17737, 2020. tab, graf
Article in English | LILACS | ID: biblio-1132050

ABSTRACT

The aim of this work was to perform solubility studies for fexofenadine hydrochloride and establish dissolution conditions for this drug in oral suspension dosage form. The solubility study was executed through the shake-flask method, below 37 ºC±1 ºC, at 100 rpm stirring for 12 h in three buffer solutions: hydrochloric acid pH 2.0, acetate pH 4.5 and phosphate pH 6.8. The dissolution test was developed in vessels containing 900 mL of the same buffer, employing the paddle apparatus in speed of 25 and 50 rpm, below 37 ºC±0.5 ºC. The drug was classified as low solubility according to the Biopharmaceutics Classification System, since the dose/solubility ratio was higher than 250 mL in all media tested (326.55 mL in buffer pH 2.0; 2,456.33 mL in buffer pH 4.5 and 1,021.16 mL in buffer pH 6.8). The dissolution test showed that a release of 85% in 30 min could be established. The rotation speed of 25 rpm, media volume of 900 mL and insertion of the samples through weighted syringes are adequate. The buffered media pH 2.0 could be chosen as dissolution media.


Subject(s)
Solubility , Suspensions/pharmacology , Dissolution/methods , Biopharmaceutics , Pharmaceutical Preparations/analysis , Chromatography, High Pressure Liquid/methods , Dosage Forms
12.
Prensa méd. argent ; 105(9 especial): 613-620, oct 2019. tab, fig, graf
Article in English | LILACS, BINACIS | ID: biblio-1046788

ABSTRACT

In searching for alternatives to traditional chemical medicines, including feed antibiotics, scientists around the world are developing a new generation of medicines, phytobiotics. This work was aimed at studying the phytobiotics (pharmaceutical substances) production technology using the method of low-temperature vacuum water-ethanol extraction of Siberian medicinal plants, followed by low-temperature vacuum drying and determination of the main biologically active substances that had the required pharmacological effect on the organisms of farm animals and poultry. The objects of the study in this work were Siberian medicinal plants and ready phytobiotics (pharmaceutical substances). The article describes the technological conditions for obtaining pharmaceutical substances and their properties concerning the content of biologically active substances. It has been found that for obtaining pharmaceutical substances, extraction should be performed in three stages: two water extractions and ethanol- water extraction. The article provides a list of medicinal plants and the amounts of biologically active substances that ensure certain pharmacological effects on the set of economically useful qualities in farm animals and poultry and contained in phytobiotics (pharmaceutical substances) based on extracts from medicinal plants.


Subject(s)
Animals , Plants, Medicinal/classification , Poultry , Technology , Biopharmaceutics , Plant Extracts/pharmacology , Phytochemicals/classification , Food Additives , Animals, Domestic
13.
Article in Chinese | WPRIM | ID: wpr-773670

ABSTRACT

The biopharmaceutics classification system( BCS) is a scientific framework or method for classifying drugs based on drug solubility and permeability,which can be used to provide drug bioavailability-absorption correlation analysis. Based on the characteristics of multi-component and multi-target of traditional Chinese medicine( TCM) as well as the concept,method and technology of BCS,the research group proposed biopharmaceutics classification system of Chinese materia medica( CMMBCS) and carried out research and data accumulation of classical prescriptions. Based on the previous research results,further development ideas under the CMMBCS concept and framework were further proposed in this study. In the course of research,the influence of the intermediate links of the complex interactions of the multi-component environment was omitted,and the component absorption studies on the main clinical effects of prescription ingredients were directly concerned,or the components and data were reversely extracted from the aspects of metabolism,pharmacodynamic pathways and absorption principles. Studies were conducted from two aspects( single component and compound prescription) to comprehensively evaluate the absorption properties of TCM compound. In the research path,the different ways in which Chinese medicine could exert its efficacy were fully considered,and CMMBCS classification and establishment rules were clarified mainly by focusing on the absorption pathway into the blood. Specifically,the network pharmacology and molecular docking technology were used to screen the compound index components of TCM; the absorption rules were studied by the physiologically based pharmacokinetic models and the absorption parameters of CMMBCS were calculated by reverse reasoning. Then the CMMBCS classification of TCM prescription was corrected by studying the efficacy or absorption pathway. In this paper,the theoretical framework and research methodology of CMMBCS were systematically improved based on the establishment of CMMBCS basic theory,the supplementary of drug-oriented research ideas and the application of modern mature Chinese medicine methodology.


Subject(s)
Biopharmaceutics , Classification , Drugs, Chinese Herbal , Classification , Materia Medica , Classification , Molecular Docking Simulation
14.
Article in Chinese | WPRIM | ID: wpr-773669

ABSTRACT

Single-pass intestinal perfusion( SPIP) is the common carrier of biopharmaceutics classification system( BCS) to study compound permeability. With the application and deepening study of BCS in the field of traditional Chinese medicine( TCM),SPIP model is becoming more and more common to study the intestinal absorption of TCM ingredients. Based on the limitations of the SPIP model in some researches on TCM permeability,it was speculated in this study that aglycone may be more suitable than the glycoside to study the intestinal absorption problem by using SPIP model. Furthermore,applicability of aglycone components was analyzed and evaluated. In this study,with quercetin,daidzein,formononetin,genistein and glycyrrhetinic acid used as research objects,the quantitative study of SPIP was used to evaluate the intestinal permeability of these aglycones and to predict the effective permeability coefficient( Peff) and absorption fraction( Fa) in human body. By combining studies comparison and analysis on multiple permeability research methods and prediction of human body absorption of aglycones in physiological-based pharmacokinetic models,this paper can further illustrate that the SPIP model is a good tool for studying the permeability of aglycones and predicting human absorption,which can provide data foundation and theoretical reference for researches on SPIP technique and BCS in intestinal absorption of TCM ingredients.


Subject(s)
Biopharmaceutics , Humans , Intestinal Absorption , Intestines , Medicine, Chinese Traditional , Perfusion , Permeability
15.
Article in Chinese | WPRIM | ID: wpr-773668

ABSTRACT

For the effects of multi-component environment on the solubility and permeability of single components,and the problems of biopharmaceutical attribute classification of single components in the compound prescriptions environment,baicalein was used as the research object in this study to investigate the biopharmaceutic attributes of single-component and their traditional Chinese medicine( TCM) biopharmaceutic attributes in the multi-component environment of Gegen Qilian Decoction. Shaking flask method,intrinsic dissolution rate test and HPLC were used to determine solubility of baicalein. Markers specified by FDA were utilized as permeable boundary reference materials to verify the applicability of the single-pass intestinal perfusion method( SPIP),and the quantitative research on the permeability of baicalein was also conducted. It is concluded that baicalein could be categorized as BCS-Ⅱ drug based on its low solubility and high intestinal permeability values,and it may be categorized into CMMBCS-I in the multi-component environment of Gegen Qilian Decoction due to its poor solubility but enhanced solubility and permeability in compound environment. This study could provide verification ideas for clinical determination of the best human oral dose of baicalein,and provide the data basis for the study of biopharmaceutics classification system of Chinese materia medica( CMMBCS).


Subject(s)
Biopharmaceutics , Classification , Drugs, Chinese Herbal , Chemistry , Flavanones , Chemistry , Humans , Intestinal Absorption , Materia Medica , Classification , Permeability , Solubility
16.
Article in Chinese | WPRIM | ID: wpr-773667

ABSTRACT

The research on biopharmaceutics classification system of Chinese materia medica( CMMBCS) should be finally implemented to the holistic research level of traditional Chinese medicine compounds,while the overall biopharmaceutical properties of traditional Chinese medicine compounds are not only the sum of solubility and permeability of each component. In this study,Gegen Qinlian Tablets was used as the research object,and the contents of 12 representative components,i.e. puerarin,daidzin,baicalin,daidzein,wogonoside,baicalein,wogonin,glycyrrhizic acid,coptisine hydrochloride,epiberberine,berberine hydrochloride and palmatine hydrochloride,were simultaneously determined by HPLC to obtain the mass weight of each component. The in vitro lipopolysaccharide( LPS)-induced RAW264. 7 cells inflammation model was established to investigate the anti-inflammatory effects of 12 representative components and obtain the efficacy weight of each component. In order to obtain the number of doses and effective permeability coefficient which can represent the overall biopharmaceutical properties of Gegen Qinlian Tablets,mass weight was combined with efficacy weight to integrate the solubility and permeability data of each component determined by typical shake flask method and in situ single pass intestinal perfusion model respectively. The results indicated that Gegen Qinlian Tablets should be categorized Ⅳ drug of the CMMBCS with low solubility and low permeability.


Subject(s)
Anti-Inflammatory Agents , Pharmacology , Biopharmaceutics , Classification , Drugs, Chinese Herbal , Classification , Pharmacology , Materia Medica , Classification , Tablets
17.
Vaccimonitor (La Habana, Print) ; 27(3)set.-dic. 2018. ilus, tab
Article in Spanish | LILACS, CUMED | ID: biblio-1094612

ABSTRACT

El objetivo de esta investigación es proponer una nueva metodología en la gestión logística de los aprovisionamientos para las industrias biotecnológicas cubanas que funcionan esencialmente con un ciclo completo de desempeño empresarial, desde la investigación básica de nuevos biofármacos, hasta llegar a la fabricación y comercialización de sus productos, donde la amplia y compleja gama de surtidos a suministrar en un contexto adverso para el país, conlleva a utilizar diferentes métodos de gestión de los aprovisionamientos en correspondencia con su destino y frecuencia de uso. De esta manera, se propone dividir las materias primas y materiales a proveer en: 1) insumos de proyectos, que emplean de forma esporádica pequeñas, pero múltiples variedades de mercancías 2) insumos de procesos, que se caracterizan por consumir altos volúmenes de productos, pero poco diversos, como sucede en las actividades de producción. Finalmente, se evalúa la implementación de este procedimiento en una de las entidades biotecnológicas de mayor prestigio en Cuba, el Centro de Inmunología Molecular, demostrando las ventajas y alcance de esta propuesta que permitió elevar la efectividad en la gestión de los aprovisionamientos, y de esta manera la eficiencia empresarial(AU)


The objective of this work is to propose a new methodology for the logistics management of supplies in Cuban biotechnological industries. They work essentially on a full cycle of enterprise performance, from basic research to the manufacture and marketing of new biopharmaceuticals products. The wide and complex range of supply requirements, in an adverse country-wide context, leads to the use of different methods for managing supplies, in accordance with their destination and frequency of use. We propose to divide the supplies and materials into two categories: 1) supplies for projects, for those that are highly varied, used sporadically and in small quantities, 2) process supplies, for those that are regularly used in large volumes -such as manufacture process-, and a relatively small variety of supply types. The implementation of this methodology is assessed in one of the most prestigious biotechnological entities in Cuba, the Molecular Immunology Center. The effectiveness in the management of supplies was increased, and therefore, business efficiency(AU)


Subject(s)
Decision Making, Organizational , Biopharmaceutics/organization & administration , Industrial Projects , Organization and Administration
18.
Rev. méd. Minas Gerais ; 28: [1-9], jan.-dez. 2018.
Article in Portuguese | LILACS | ID: biblio-967878

ABSTRACT

Medicamentos com atividade sobre a mesma família de enzimas do citocromo P450 (CYP450), quando administrados concomitantemente, podem interagir entre si e afetar o clearance sistêmico de um dos fármacos, resultando em redução da efetividade ou aumento da toxicidade do medicamento afetado. O presente estudo tem como objetivo determinar a prevalência de uso de medicamentos com atividade sobre isoenzimas do CYP450 por pacientes idosos em domicílio. Trata-se de um estudo transversal, retrospectivo, descritivo, realizado em hospital público geral de ensino de Belo Horizonte, Minas Gerais. Foram incluídos no estudo 190 pacientes com 60 anos ou mais, internados de janeiro a dezembro de 2010 na enfermaria de clínica médica do hospital e em uso domiciliar de medicamentos com registro no prontuário. Os fármacos com atividade sobre as isoenzimas da família CYP450 foram classificados em indutores, inibidores ou substratos segundo literatura especializada. Dentre os 190 idosos incluídos na investigação, 99 (52,1%) eram do sexo feminino. A mediana da idade foi 69,5 e intervalo interquartil (IQR)12. Foi observado que 172 pacientes (90,5%) utilizaram algum fármaco com atividade sobre CYP450. Em relação aos fármacos utilizados, verificouse que 94 (59,1 %) exerciam atividade sobre enzimas do CYP450, o que implica em alto potencial para ocorrência de interações medicamentosas. Fica evidente a importância da informação acerca da atividade dos fármacos sobre o CYP450, para subsidiar as decisões clínicas em relação à farmacoterapia do idoso, contribuindo assim para maior segurança e efetividade no uso dos medicamentos. (AU)


Drugs that act on the same family of CYP450 enzymes, when administered concurrently, may interact among themselves and affect the systemic clearance of one of the drugs, reducing the effectiveness or increasing the toxicity of the affected medication. The present study aims to determine the prevalence use of drugs by elderly patients at home with activity on CYP450 isoenzymes. This is a cross-sectional, retrospective, descriptive study executed at a general public teaching hospital in Belo Horizonte, Minas Gerais. A hundred ninety patients with 60 years or older, admitted to internal medicine ward of the hospital from January to December 2010 and who had medical records of medicine used at home were included in the study. Drugs with activity on CYP450 isoenzymes family were classified into inducers, inhibitors or substrates according specialized literature. Among the 190 elderly included in the investigation, 99 (52.1%) were from the female gender. The median age was of 69.5 and interquartile range (IQR) 12. It was observed that 172 patients (90.5%) used any drug with activity on CYP450. Concerning the drugs used, it was found that 94 (59.1%) had activity on CYP450 enzymes, what implicates in a high potential to the occurrence of drugdrug interactions. It becomes evident the importance of information about the activity of drugs on CYP450, to subsidize the clinical decisions concerning the geriatric pharmacotherapy, therefore contributing to a higher security and effectiveness in the medications usage. (AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Pharmacologic Actions , Cytochrome P-450 Enzyme System , Biopharmaceutics , Pharmacokinetics , Pharmaceutical Preparations , Frail Elderly , Drug Therapy
19.
Pesqui. bras. odontopediatria clín. integr ; 18(1): 3890, 15/01/2018. tab
Article in English | LILACS, BBO | ID: biblio-966733

ABSTRACT

Objective: To investigate the prevalence and contributing factors of antibiotic selfmedication for oral conditions in dental patients. Material and Methods: A questionnaire was distributed to 501 patients attending Taibah University Dental College and Hospital, Al Madinah, Saudi Arabia during late 2016. Questions were on socio-demographic characteristics, and pattern of antibiotic self-medication for oral disease. Statistical analysis was performed using IBM SPSS software version 21. Statistical significance level was set at p ≤.05. Results: Age range was 15-64 years (29.08±9.32 years) with 297 females (59.3%) and 204 males (40.7%). 135 patients (27%) self-medicated with antibiotics for oral disease. This practice was statistically significantly associated with the older adults (p=0.001), lack of medical or dental insurance (p=0.014 and 0.007, respectively), and poor dental attendance (p=0.021). A number of 26 (25.7%) perceived analgesics as antibiotics. Amoxicillin-clavulanic acid was the most commonly cited antibiotic by 18 patients (17.8%). Dental pain was the most frequently reported oral condition. Pharmacists were the most common source for antibiotic prescription cited by 58 (57.4%). Conclusion: Antibiotic self-medication for oral disease is associated with the use of broad-spectrum antibiotics for non-indicated clinical oral conditions. The practice was encouraged by lenient behavior of pharmacists, lack of health insurance, and poor dental attendance.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Self Medication/standards , Biopharmaceutics , Anti-Bacterial Agents , Mouth Diseases , Saudi Arabia , Chi-Square Distribution , Oral Health , Cross-Sectional Studies , Surveys and Questionnaires , Dental Care
20.
Pesqui. bras. odontopediatria clín. integr ; 18(1): 3976, 15/01/2018. tab
Article in English | LILACS, BBO | ID: biblio-966835

ABSTRACT

Objective: To evaluate the knowledge, attitudes, and practices on oral hygiene (OH) of students of three Quranic schools of Koutiala, Mali. Material and Methods: It was carried out a descriptive prospective study with 300 students in three Quranic schools in the city of Koutiala, Mali. The data analyzed with the Epi Info 3.5.4 software. Results: The male sex was the most represented with 57.7% and the sex ratio = 0.73. The most represented age group was 8-12 with 52% with an average age of 17 years and minimum and maximum age of was 8 and 26 years. It was observed that 98.3% of students had a notion of knowledge about oral hygiene and this information was given by parents / elders in 60% of cases. They claimed that people who do not brush their teeth properly are the most likely to get tooth decay in 93.3% of cases. Regarding dental caries, 61.3% of students said that caries is transmitted by lack of oral hygiene; 33.3% of students said that using toothbrushes and having good oral hygiene are ways to avoid oral diseases. It was thought in 93.3% of cases that a good oral hygiene prevents oral diseases. The students brushed their teeth every day (98%) and they had a consultation with the dental surgeon in 8.7% of the cases. Conclusion: This study shows that students had knowledge of oral hygiene and preventive measures. Efforts should be made to promote, prevent, screen and manage oral diseases in Quranic schools while involving parents in the processes.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Self Medication/standards , Dentists , Anti-Bacterial Agents , Mouth Diseases , Biopharmaceutics , Surveys and Questionnaires
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