Mariana Ortiz Reynoso - Academia.edu (original) (raw)

Papers by Mariana Ortiz Reynoso

History of Pharmacy and Pharmaceuticals

This database contains the data obtained from the evaluation of the impact of an educational inte... more This database contains the data obtained from the evaluation of the impact of an educational intervention on pharmcovigilance abilities and attitudes in health professionals, carried out by the autors in a hospital in Mexico

10 Años de Acreditación Farmacéutica en México, 2018

México cumple 10 años de acreditar programas de estudios de Farmacia. El libro hace un recuento d... more México cumple 10 años de acreditar programas de estudios de Farmacia. El libro hace un recuento de las metas alcanzadas y un análisis con otros países para establecer nuevos retos en materia de acreditación de programas de estudio de Farmacia.Asociación Farmacéutica Mexicana, A.C

I. INTRODUCTION Within the pharmaceutical industry, the raw materials used in the manufacture of ... more I. INTRODUCTION Within the pharmaceutical industry, the raw materials used in the manufacture of solid oral drugs (SOD) must be evaluated according to pharmacopoeial monographs. These monographs precisely consist in the verification of critical quality attributes (CQA) related mostly to the identity and purity of the molecules that were established in phases prior to commercialization of the product. However, the excipients and active pharmaceutical ingredients (API) may present differences in non-pharmacopoeial tests that are not routinely evaluated by the Quality Control (QC) department, such as the crystallographic characterization or the particle size distribution (PSD) and shape. These non-pharmacopoeial attributes should be considered when establishing a Target Product Profile (TPP). Shekunov and collaborators sustain that the effects of particle size and shape, purity and structural defects, followed by less-pronounced but significant variations in the thermodynamic and mechanical properties, are the main source of the problems of batch-to-batch variation and inconsistency in the properties of tablets [1]. Buckton assures that the energy of the manufacturing process and the manner and capacity of the materials to recover from the tension produced by this energy affects batch-to-batch uniformity [2]. Differences between suppliers or batches from the same supplier that are not detectable by ABSTRACT:All raw materials used for solid oral drugs manufacturing must be evaluated according to the pharmacopoeial monographs, which consist in a verification of critical quality attributes related to the identity and purity of the molecule. However, active pharmaceutical ingredients may present differences in non-pharmacopoeial tests, such as particle size and shape or flow. Although these differences are not evaluated routinely by Quality Control area, they can alter the technological performance during production, as well the stability and ultimately the efficacy of a pharmaceutical product. In this study, 10 production batches of magnesium valproate were evaluated, characterizing flow index, fusion enthalpy and particle shape and size distribution. An analysis of variance was carried out, finding statistically-significant differences in the flow index, particle shape and fusion enthalpy tests for two batches. These differences may be due to small variations in the crystalline configurations. The study showed differences in the characterization of fundamental and functional properties of the particles of the active pharmaceutical ingredient evaluated, which could have an impact on the manufacturing processes and affect therapeutic efficacy.

Iranian Journal of Parasitology

Drugs' pharmacokinetics and pharmacodynamics can be affected by diverse genetic variations, w... more Drugs' pharmacokinetics and pharmacodynamics can be affected by diverse genetic variations, within which simple nucleotide polymorphisms (SNPs) are the most common. Genetic variability is one of the factors that could explain questions like why a given drug does not have the desired effect or why do adverse drug reactions arise. In this retrospective observational study, literature search limits were set within PubMed database as well as the epidemiological bulletins published by the Mexican Ministry of Health, from Jan 1st 2001 to Mar 31st 2017 (16 years). Metabolism of antiparasitic drugs and their interindividual responses are mainly modified by variations in cytochrome P450 enzymes. These enzymes show high frequencies of polymorphic variability thus affecting the expression of CYP2C, CYP2A, CYP2A6, CYP2D6, CYP2E6 and CYP2A6 isoforms. Research in this field opens the door to new personalized treatment approaches in medicine. Clinical and pharmacological utility yield by apply...

Resumen es: El presente trabajo revisa el marco legal aplicable al ejercicio farmaceutico en el p... more Resumen es: El presente trabajo revisa el marco legal aplicable al ejercicio farmaceutico en el periodo de 1917, cuando se expidio la nueva Constitucion Politica de ...

Historia de la regulación de los medicamentos genéricos en méxico: 1977 a la fecHa Nota: Artículo... more Historia de la regulación de los medicamentos genéricos en méxico: 1977 a la fecHa Nota: Artículo recibido el 30 de julio de 2017 y aceptado el 02 de mayo de 2018. ARTÍCULO DE REVISIÓN resumen Esta es una revisión del desarrollo histórico de la legislación en materia de medicamentos genéricos en México, con especial énfasis en la evolución del Cuadro Básico de Medicamentos desde 1975 hasta la actualidad y en la Norma Oficial Mexicana 177 versiones 1998 y 2013. Se discute también el impacto que tienen estos insumos para la salud en la economía nacional, puesto que México está considerado como el primer exportador de medicamentos en América Latina. Se revisa el uso de la prueba in vitro de disolución como una herramienta necesaria tanto en la fase de investigación y desarrollo, como en la de la producción industrial de medicamentos. Asimismo, se revisa el sistema de clasificación biofarmacéutica, un modelo que puede ser usado como guía para definir una prueba de intercambiabilidad. Los medicamentos genéricos son un insumo de especial importancia para el Estado mexicano porque son un elemento clave para abatir el gasto en salud pública. Palabras Clave: medicamento genérico, sistema de clasificación biofarmacéutica, prueba de disolución, legislación farmacéutica.

1 Alcantara-Fierro Edna Teresa, 2 Ortiz-Reynoso Mariana, 3 Morales-Ávila Enrique, 4 Hernández-Bal... more 1 Alcantara-Fierro Edna Teresa, 2 Ortiz-Reynoso Mariana, 3 Morales-Ávila Enrique, 4 Hernández-Baltazar Efren 1 Msc, Pharmacy Laboratory, School of Chemistry, Universidad Autónoma del Estado de México, Toluca, Mexico. 2 PhD, Leader of Pharmacy Laboratory, School of Chemistry, Universidad Autónoma del Estado de México, Toluca, Mexico. 3 PhD, Full-time professor, School of Chemistry, Universidad Autónoma del Estado de México, Toluca, Mexico. 4 PhD, Leader of School of Pharmacy, Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, Mexico. Corresponding Author: PhD. Ortiz-Reynoso Mariana, Paseo Colón S/N, Residencial Colón, 50120, Toluca de Lerdo, Estado de México.

El equipo e instrumental de analisis de este proyecto fue comprado con los recursos derivados de ... more El equipo e instrumental de analisis de este proyecto fue comprado con los recursos derivados de los proyectos antes descritos.

Background: Drugs’ pharmacokinetics and pharmacodynamics can be affected by diverse genetic varia... more Background: Drugs’ pharmacokinetics and pharmacodynamics can be affected by diverse genetic variations, within which simple nucleotide polymorphisms (SNPs) are the most common. Genetic variability is one of the factors that could explain questions like why a given drug does not have the desired effect or why do adverse drug reactions arise. Methods: In this retrospective observational study, literature search limits were set within PubMed database as well as the epidemiological bulletins published by the Mexican Ministry of Health, from Jan 1st 2001 to Mar 31st 2017 (16 years). Results: Metabolism of antiparasitic drugs and their interindividual responses are mainly modified by variations in cytochrome P450 enzymes. These enzymes show high frequencies of polymorphic variability thus affecting the expression of CYP2C, CYP2A, CYP2A6, CYP2D6, CYP2E6 and CYP2A6 isoforms. Research in this field opens the door to new personalized treatment approaches in medicine. Conclusion: Clinical and ...

Introduccion : En el tratamiento de la artritis reumatoide, las proteinas biotecnologicas son uti... more Introduccion : En el tratamiento de la artritis reumatoide, las proteinas biotecnologicas son utilizadas cada vez mas como agentes terapeuticos. Estas proteinas pueden inducir una respuesta inmunitaria humoral y celular. Los llamados biofarmacos llegaron para revolucionar el tratamiento de distintas enfermedades, en especial las reumaticas. Aunque existen medicamentos biotecnologicos eficaces ante estas afectaciones, estudios recientes han denotado que su consumo puede originar una respuesta inmunogenica en el paciente, como la formacion de auto-anticuerpos, que llegan incluso a inhibir la actividad terapeutica buscada, resultando una respuesta clinica nula. Algunas investigaciones afirman encontrar una respuesta a nivel inmunogenico tras su consumo, otras senalan que solo se forman auto-anticuerpos de naturaleza no neutralizante. Objetivo : Establecer la causalidad de la inmunogenicidad asociada al uso de farmacos biologicos anti-TNF-α en artritis reumatoide. Metodos : Se realizo u...

The aim of the present essay is to analyze the work performed at the National Medical Institute (... more The aim of the present essay is to analyze the work performed at the National Medical Institute (NMI) with a group of plants remarkable for containing significant psychoactive principles. The studies on the NMI conducted up to the present time did not analyze in depth the place those substances had in the Institute’s research agenda. For that reason we sought to identify the medicinal plants studied at NMI together with their active principles, the diseases to which they were experimentally applied, and the procedures used to study them. To illustrate that process we present two particular cases: peyote ( Lophophora williamsii (Lem.) J.M. Coult) and white sapote ( Casimiroa edulis La Llave & Lex.).

Environmental Toxicology, 2017

Thirty million people worldwide consume each day nonsteroidal anti-inflammatory drugs (NSAIDs), a... more Thirty million people worldwide consume each day nonsteroidal anti-inflammatory drugs (NSAIDs), a heterogeneous group of pharmaceuticals used for its analgesic, antipyretic, and antiinflammatory properties. Recent studies report high NSAID concentrations in wastewater treatment plant effluents, in surface, ground, and drinking water, and in sediments. NSAIDs are also known to induce toxicity on aquatic organisms. However, toxicity in natural ecosystems is not usually the result of exposure to a single substance but to a mixture of toxic agents, yet only a few studies have evaluated the toxicity of mixtures. The aim of this study was to evaluate the toxicity induced by diclofenac (DCF), ibuprofen (IBP), and their mixture on a species of commercial interest, the common carp Cyprinus carpio. The median lethal concentration of IBP and DCF was determined, and oxidative stress was evaluated using the following biomarkers: lipid peroxidation and activity of the antioxidant enzymes superoxide dismutase, catalase and glutathione peroxidase. Cyto-genotoxicity was evaluated by micronucleus test, comet assay, and the specific activity of caspase-3. Results show that DCF, IBP, and a mixture of these pharmaceuticals induced free radical production, oxidative stress and cyto-genotoxicity in tissues of C. carpio. However, a greater effect was elicited by the mixture than by either pharmaceutical alone in some biomarkers evaluated, particularly in gill.

Pharmacy

COPHELA (Cooperation in Quality Assurance for Pharmacy Education and Training between Europe and ... more COPHELA (Cooperation in Quality Assurance for Pharmacy Education and Training between Europe and Latin America), a collaborative project between the European Union (EU) and Latin America, will produce on-line courses for the master degree in pharmacy. The program runs from 2019 through 2021. It is funded by the Erasmus+ program of the Education, Audio-visual and Culture Executive Agency (EACEA) of the European Commission. The partners are EU and Latin American universities. These are accompanied by associated partners from EU and Latin American universities, as well as from governmental and non-governmental organizations, such as pharmacy chambers and educational associations. The project is coordinated by the University of Granada, Spain (first author of this paper). It will produce distance learning master degree courses in a dozen fields of specialized pharmaceutical science education and practice, ranging from patient care to industrial pharmacy. This paper describes the design ...

History of Pharmacy and Pharmaceuticals

This database contains the data obtained from the evaluation of the impact of an educational inte... more This database contains the data obtained from the evaluation of the impact of an educational intervention on pharmcovigilance abilities and attitudes in health professionals, carried out by the autors in a hospital in Mexico

10 Años de Acreditación Farmacéutica en México, 2018

México cumple 10 años de acreditar programas de estudios de Farmacia. El libro hace un recuento d... more México cumple 10 años de acreditar programas de estudios de Farmacia. El libro hace un recuento de las metas alcanzadas y un análisis con otros países para establecer nuevos retos en materia de acreditación de programas de estudio de Farmacia.Asociación Farmacéutica Mexicana, A.C

I. INTRODUCTION Within the pharmaceutical industry, the raw materials used in the manufacture of ... more I. INTRODUCTION Within the pharmaceutical industry, the raw materials used in the manufacture of solid oral drugs (SOD) must be evaluated according to pharmacopoeial monographs. These monographs precisely consist in the verification of critical quality attributes (CQA) related mostly to the identity and purity of the molecules that were established in phases prior to commercialization of the product. However, the excipients and active pharmaceutical ingredients (API) may present differences in non-pharmacopoeial tests that are not routinely evaluated by the Quality Control (QC) department, such as the crystallographic characterization or the particle size distribution (PSD) and shape. These non-pharmacopoeial attributes should be considered when establishing a Target Product Profile (TPP). Shekunov and collaborators sustain that the effects of particle size and shape, purity and structural defects, followed by less-pronounced but significant variations in the thermodynamic and mechanical properties, are the main source of the problems of batch-to-batch variation and inconsistency in the properties of tablets [1]. Buckton assures that the energy of the manufacturing process and the manner and capacity of the materials to recover from the tension produced by this energy affects batch-to-batch uniformity [2]. Differences between suppliers or batches from the same supplier that are not detectable by ABSTRACT:All raw materials used for solid oral drugs manufacturing must be evaluated according to the pharmacopoeial monographs, which consist in a verification of critical quality attributes related to the identity and purity of the molecule. However, active pharmaceutical ingredients may present differences in non-pharmacopoeial tests, such as particle size and shape or flow. Although these differences are not evaluated routinely by Quality Control area, they can alter the technological performance during production, as well the stability and ultimately the efficacy of a pharmaceutical product. In this study, 10 production batches of magnesium valproate were evaluated, characterizing flow index, fusion enthalpy and particle shape and size distribution. An analysis of variance was carried out, finding statistically-significant differences in the flow index, particle shape and fusion enthalpy tests for two batches. These differences may be due to small variations in the crystalline configurations. The study showed differences in the characterization of fundamental and functional properties of the particles of the active pharmaceutical ingredient evaluated, which could have an impact on the manufacturing processes and affect therapeutic efficacy.

Iranian Journal of Parasitology

Drugs' pharmacokinetics and pharmacodynamics can be affected by diverse genetic variations, w... more Drugs' pharmacokinetics and pharmacodynamics can be affected by diverse genetic variations, within which simple nucleotide polymorphisms (SNPs) are the most common. Genetic variability is one of the factors that could explain questions like why a given drug does not have the desired effect or why do adverse drug reactions arise. In this retrospective observational study, literature search limits were set within PubMed database as well as the epidemiological bulletins published by the Mexican Ministry of Health, from Jan 1st 2001 to Mar 31st 2017 (16 years). Metabolism of antiparasitic drugs and their interindividual responses are mainly modified by variations in cytochrome P450 enzymes. These enzymes show high frequencies of polymorphic variability thus affecting the expression of CYP2C, CYP2A, CYP2A6, CYP2D6, CYP2E6 and CYP2A6 isoforms. Research in this field opens the door to new personalized treatment approaches in medicine. Clinical and pharmacological utility yield by apply...

Resumen es: El presente trabajo revisa el marco legal aplicable al ejercicio farmaceutico en el p... more Resumen es: El presente trabajo revisa el marco legal aplicable al ejercicio farmaceutico en el periodo de 1917, cuando se expidio la nueva Constitucion Politica de ...

Historia de la regulación de los medicamentos genéricos en méxico: 1977 a la fecHa Nota: Artículo... more Historia de la regulación de los medicamentos genéricos en méxico: 1977 a la fecHa Nota: Artículo recibido el 30 de julio de 2017 y aceptado el 02 de mayo de 2018. ARTÍCULO DE REVISIÓN resumen Esta es una revisión del desarrollo histórico de la legislación en materia de medicamentos genéricos en México, con especial énfasis en la evolución del Cuadro Básico de Medicamentos desde 1975 hasta la actualidad y en la Norma Oficial Mexicana 177 versiones 1998 y 2013. Se discute también el impacto que tienen estos insumos para la salud en la economía nacional, puesto que México está considerado como el primer exportador de medicamentos en América Latina. Se revisa el uso de la prueba in vitro de disolución como una herramienta necesaria tanto en la fase de investigación y desarrollo, como en la de la producción industrial de medicamentos. Asimismo, se revisa el sistema de clasificación biofarmacéutica, un modelo que puede ser usado como guía para definir una prueba de intercambiabilidad. Los medicamentos genéricos son un insumo de especial importancia para el Estado mexicano porque son un elemento clave para abatir el gasto en salud pública. Palabras Clave: medicamento genérico, sistema de clasificación biofarmacéutica, prueba de disolución, legislación farmacéutica.

1 Alcantara-Fierro Edna Teresa, 2 Ortiz-Reynoso Mariana, 3 Morales-Ávila Enrique, 4 Hernández-Bal... more 1 Alcantara-Fierro Edna Teresa, 2 Ortiz-Reynoso Mariana, 3 Morales-Ávila Enrique, 4 Hernández-Baltazar Efren 1 Msc, Pharmacy Laboratory, School of Chemistry, Universidad Autónoma del Estado de México, Toluca, Mexico. 2 PhD, Leader of Pharmacy Laboratory, School of Chemistry, Universidad Autónoma del Estado de México, Toluca, Mexico. 3 PhD, Full-time professor, School of Chemistry, Universidad Autónoma del Estado de México, Toluca, Mexico. 4 PhD, Leader of School of Pharmacy, Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, Mexico. Corresponding Author: PhD. Ortiz-Reynoso Mariana, Paseo Colón S/N, Residencial Colón, 50120, Toluca de Lerdo, Estado de México.

El equipo e instrumental de analisis de este proyecto fue comprado con los recursos derivados de ... more El equipo e instrumental de analisis de este proyecto fue comprado con los recursos derivados de los proyectos antes descritos.

Background: Drugs’ pharmacokinetics and pharmacodynamics can be affected by diverse genetic varia... more Background: Drugs’ pharmacokinetics and pharmacodynamics can be affected by diverse genetic variations, within which simple nucleotide polymorphisms (SNPs) are the most common. Genetic variability is one of the factors that could explain questions like why a given drug does not have the desired effect or why do adverse drug reactions arise. Methods: In this retrospective observational study, literature search limits were set within PubMed database as well as the epidemiological bulletins published by the Mexican Ministry of Health, from Jan 1st 2001 to Mar 31st 2017 (16 years). Results: Metabolism of antiparasitic drugs and their interindividual responses are mainly modified by variations in cytochrome P450 enzymes. These enzymes show high frequencies of polymorphic variability thus affecting the expression of CYP2C, CYP2A, CYP2A6, CYP2D6, CYP2E6 and CYP2A6 isoforms. Research in this field opens the door to new personalized treatment approaches in medicine. Conclusion: Clinical and ...

Introduccion : En el tratamiento de la artritis reumatoide, las proteinas biotecnologicas son uti... more Introduccion : En el tratamiento de la artritis reumatoide, las proteinas biotecnologicas son utilizadas cada vez mas como agentes terapeuticos. Estas proteinas pueden inducir una respuesta inmunitaria humoral y celular. Los llamados biofarmacos llegaron para revolucionar el tratamiento de distintas enfermedades, en especial las reumaticas. Aunque existen medicamentos biotecnologicos eficaces ante estas afectaciones, estudios recientes han denotado que su consumo puede originar una respuesta inmunogenica en el paciente, como la formacion de auto-anticuerpos, que llegan incluso a inhibir la actividad terapeutica buscada, resultando una respuesta clinica nula. Algunas investigaciones afirman encontrar una respuesta a nivel inmunogenico tras su consumo, otras senalan que solo se forman auto-anticuerpos de naturaleza no neutralizante. Objetivo : Establecer la causalidad de la inmunogenicidad asociada al uso de farmacos biologicos anti-TNF-α en artritis reumatoide. Metodos : Se realizo u...

The aim of the present essay is to analyze the work performed at the National Medical Institute (... more The aim of the present essay is to analyze the work performed at the National Medical Institute (NMI) with a group of plants remarkable for containing significant psychoactive principles. The studies on the NMI conducted up to the present time did not analyze in depth the place those substances had in the Institute’s research agenda. For that reason we sought to identify the medicinal plants studied at NMI together with their active principles, the diseases to which they were experimentally applied, and the procedures used to study them. To illustrate that process we present two particular cases: peyote ( Lophophora williamsii (Lem.) J.M. Coult) and white sapote ( Casimiroa edulis La Llave & Lex.).

Environmental Toxicology, 2017

Thirty million people worldwide consume each day nonsteroidal anti-inflammatory drugs (NSAIDs), a... more Thirty million people worldwide consume each day nonsteroidal anti-inflammatory drugs (NSAIDs), a heterogeneous group of pharmaceuticals used for its analgesic, antipyretic, and antiinflammatory properties. Recent studies report high NSAID concentrations in wastewater treatment plant effluents, in surface, ground, and drinking water, and in sediments. NSAIDs are also known to induce toxicity on aquatic organisms. However, toxicity in natural ecosystems is not usually the result of exposure to a single substance but to a mixture of toxic agents, yet only a few studies have evaluated the toxicity of mixtures. The aim of this study was to evaluate the toxicity induced by diclofenac (DCF), ibuprofen (IBP), and their mixture on a species of commercial interest, the common carp Cyprinus carpio. The median lethal concentration of IBP and DCF was determined, and oxidative stress was evaluated using the following biomarkers: lipid peroxidation and activity of the antioxidant enzymes superoxide dismutase, catalase and glutathione peroxidase. Cyto-genotoxicity was evaluated by micronucleus test, comet assay, and the specific activity of caspase-3. Results show that DCF, IBP, and a mixture of these pharmaceuticals induced free radical production, oxidative stress and cyto-genotoxicity in tissues of C. carpio. However, a greater effect was elicited by the mixture than by either pharmaceutical alone in some biomarkers evaluated, particularly in gill.

Pharmacy

COPHELA (Cooperation in Quality Assurance for Pharmacy Education and Training between Europe and ... more COPHELA (Cooperation in Quality Assurance for Pharmacy Education and Training between Europe and Latin America), a collaborative project between the European Union (EU) and Latin America, will produce on-line courses for the master degree in pharmacy. The program runs from 2019 through 2021. It is funded by the Erasmus+ program of the Education, Audio-visual and Culture Executive Agency (EACEA) of the European Commission. The partners are EU and Latin American universities. These are accompanied by associated partners from EU and Latin American universities, as well as from governmental and non-governmental organizations, such as pharmacy chambers and educational associations. The project is coordinated by the University of Granada, Spain (first author of this paper). It will produce distance learning master degree courses in a dozen fields of specialized pharmaceutical science education and practice, ranging from patient care to industrial pharmacy. This paper describes the design ...