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Comparison on the Pharmacokinetics and Weight Reduction of Clobenzorex Slow Release and Immediate Release Formulations in Obese Patients

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Pharmacology & Pharmacy 2013年第2期4卷 218-221页

作者： Federico Argüelles-Tello Miriam del C.Carrasco-Portugal Norma A.Carrasco-Portugal jose Carlos Aguilar-Carrasco Selene I.Patino-Camacho Cecilia Fernandez del Valle Gerardo Reyes-Garcia francisco j.flores-murrieta Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina del Instituto Politecnico NacionalMexico CityMexico Unidad de Investigación en Farmacología Instituto Nacional de Enfermedades Respiratorias Ismael Cosío VillegasMexico CityMexico Centro de Estudios Biofarmaceuticos Mexico CityMexico Instituto Nacional de Perinatología Mexico CityMexico

Clobenzorex is an anorexigenic drug that is widely used in Mexicofor the treatment of obesity, since it helps to reduce body weight. This drug is available as immediate release capsules. To improve compliance to treatment, it was developed a new slow release formulation. In order to establish its usefulness, oral pharmacokinetics and weight reduction of slow release and immediate release formulations of clobenzorex in obese patients were compared. Sixty patients with a BMI higher than 27 kg/m2 were included in the study. Two groups of 30 patients were formed, one of them received 30 mg immediate release formulation b.i.d. and the other group received one 60 mg slow release formulation once a day, since under this scheme these formulations are prescribed. Blood samples were obtained at selected times during the first day and once weekly during 4 weeks. After the last dose, samples were obtained at selected times during 48 h. Plasma levels were determined by HPLC-MS/MS and pharmacokinetic parameters were obtained. Reduction in Cmax due to increased tmax, as well as, increased half-life were observed with the slow release formulation in comparison with immediate release formulation. Although lower plasma levels of clobenzorex were reached with the slow release formulation, reduction of body weight was similar with both products. Based on the results, it was concluded that slow release formulation of clobenzorex is an adequate formulation of clobenzorex, since pharmacokinetics and effects observed are compatible with a once a day administration.

关键词： Clobenzorex Pharmacokinetics Slow Release Formulation

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Comparative Pharmacokinetic Study between Metformin Alone and Combined with Orlistat in Healthy Mexican Volunteers

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Pharmacology & Pharmacy 2012年第3期3卷 300-306页

作者： Noemí Santos-Caballero francisco javier flores-murrieta Landsteiner Scientific S.A. de C.V. México D.F. Mexico Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional México D.F. Mexico

Traditional treatment of type 2 diabetes mellitus (T2DM) has focused on correcting hyperglycemia. However, T2DM is almost always accompanied by other conditions and risk factors that affect its morbidity and mortality. Obesity represents one of the main risk factors associated in the T2DM and a modest weight loss around 5% is linked with significant reduction in the blood glucose levels. The objective of this study was to compare the pharmacokinetic parameters between two formulations of metformin, alone or combined with orlistat, in healthy volunteers. A single-blinded, single dose, two-period, two-sequence, crossover, randomized and balanced study design with a 7-day washout period was performed in 26 Mexican volunteers. Plasma samples were collected over a 24-hour period after administration of 500 mg metformin alone or combined with 60 mg orlistat in each period. A validated high-performance liquid chromatography coupled with a ultraviolet detector was used to analyze metformin concentration in plasma. Bioequivalence between metformin alone and metformin combined with orlistat was determined when the ratio for the 90% confidence intervals (CI) of area under the curve (AUC24h) and maximum concentration (Cmax) of the two formulations were within 80% and 125%. In the current study, the mean ± standard deviation (SD) of Cmax, AUC24h and AUC∞ of the formulation containing only metformin were 1.39 ± 0.44 μg/mL, 7.59 ± 3.17 μg h/mL and 8.48 ± 4.13 μg h/mL, respectively, while the mean ± SD of Cmax, AUC24h and AUC∞ of the formulation containing metformin and orlistat were 1.38 ± 0.48 μg/mL, 7.80 ± 2.83 μg h/mL and 9.13 ± 4.29 μg h/mL, respectively. The parametric 90% CI for Cmax and AUC24h were 87.5-109.3 and 88.7-124.7, respectively. These results suggest that both formulations are bioequivalent and there is not pharmacokinetic interaction between metformin and orlistat.

关键词： Metformin Orlistat Diabetes Obesity Bioequivalence Pharmacokinetic

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Gender Differences in the Pharmacokinetics of Oral Drugs

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Pharmacology & Pharmacy 2011年第1期2卷 31-41页

作者： Miriam del Carmen Carrasco-Portugal francisco javier flores-murrieta 不详

Establishment of rational dosage regimens requires the knowledge of pharmacokinetics and pharmacodynamics in the target population. It has been established that side effects produced by drugs are more frequent in women than in men. This may be due to two possibilities, one is that normalized dose received by women is higher than men and the other is that anatomical and physiological characteristics are a quite different. In this review, some aspects that may play a role in the generation of such differences are analyzed, including the impact on absorption, distribution, metabolism and excretion of drugs. Most of the changes can be explained by differences in volume of distribution and systemic clear- ance, however, presystemic clearance also seems to play a role in such dissimilarities. The final result, in general, is that women have higher plasma levels of drugs and usually these differences are reduced or abolished when data are normalized by the body weight, since both, volume of distribution and systemic clearance are influenced by it;however, there are some cases in which differences remain. Further research oriented to establish the role of each of the ana- tomical and physiological differences in the oral pharmacokinetics of drugs is warranted.

关键词： Gender-Related Differences Oral Pharmacokinetics Sex Differences

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Safety and Efficacy of Oral Mirodenafil in Mexican with Erectile Dysfunction

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International journal of Clinical Medicine 2016年第9期7卷 628-638页

作者： juan Gerardo Reyes-García Noemí Santos-Caballero francisco javier flores-murrieta Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional Ciudad de México Mexico Landsteiner Scientific S.A. de C.V. Ciudad de México Mexico Unidad de Investigación en Farmacología Instituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas” Ciudad de México Mexico

Erectile dysfunction is treated with 5-phospodiesterase inhibitors as Mirodenafil, which has shown its efficacy and safety in Koreans, however;no information in other populations is available. An open clinical trial study was designed to evaluate the efficacy and safety in real life of a fixed-dose of Mirodenafil in Mexican patients with erectile dysfunction. Forty-seven male patients received a 100 mg tablet of Mirodenafil, during 12 weeks. Primary outcome efficacy measure was the percentage of male patients with successful intercourse. Secondary outcomes measures included patient satisfaction, mood and self-esteem level. Safety assessments included laboratory tests, vital signs, physical examination, 12-lead electrocardiogram recordings, and incidence of adverse events by patients. Oral administration of Mirodenafil improved in an 80% - 90% the number of successful intercourses from 7 to 84 days of treatment. Moreover, patients reported a significant increment in their sexual satisfaction, mood and self-esteem. Mirodenafil treatment did not modify vital signs nor anthropometric parameters during 84 days. Mild headache was the most frequent adverse event (17.0%) and there were no severe adverse events during pharmacological treatment. Data suggest that oral Mirodenafil is safety, well tolerated and effective in the Mexican population with erectile dysfunction.

关键词： Efficacy Erectile Dysfunction Mexicans Mirodenafil Safety

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Oral Pharmacokinetics of Mirodenafil in Mexican Healthy Volunteers

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Pharmacology & Pharmacy 2014年第1期5卷 112-116页

作者： Miriam del Carmen Carrasco-Portugal francisco javier flores-murrieta juan Gerardo Reyes-García Noemí Santos-Caballero Landsteiner Scientific S.A. de C.V. México DF México Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional México DF México Unidad de Investigación en Farmacología Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas” México DF México Unidad de Investigación en Farmacología Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas” México DF México Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional México DF México

Mirodenafil is a 5-phosphodiesterase inhibitor that is currently marketed in Korea for the treatment of erectile dysfunction;however, no information in other populations is available. It has been described that Mirodenafil is metabolized by CYP3A4, a metabolic pathway in which interethnic differences have been reported. The purpose of this study was to characterize the oral pharmacokinetics of Mirodenafil in Mexicans. Seventeen male healthy volunteers were enrolled in this study. After an overnight fast, volunteers received an oral 100 mg dose and blood samples were collected at selected times during 24 h. Plasma was stored frozen and analyzed by an HPLC method. Pharmacokinetic parameters obtained were: Cmax 331.129 ± 32.689 ng/mL, tmax 1.574 ± 0.293 h, AUC24h 883.293 ± 104.088 ng·h/mL, AUC￥ 976.477 ± 108.812 ng·h/mL and t1/2 1.807 ± 0.171 h. Parameter values observed in this study are similar to those reported in Koreans. Since efficacy and safety studies of Mirodenafil have been conducted in Koreans, it is expected that dosage regime to employ in Mexicans should be similar to the approved for Korean population.

关键词： Erectile Dysfunction Healthy Volunteers Mexican Mirodenafil Pharmacokinetic

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Evaluation of the Influence of Hyoscine Butylbromide on the Oral Bioavailability of Lansoprazole in Healthy Adult Volunteers

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Pharmacology & Pharmacy 2016年第7期7卷 264-271页

作者： Noemí Santos-Caballero Lina Marcela Barranco-Garduño josé Carlos Aguilar-Carrasco Miriam del Carmen Carrasco-Portugal francisco javier flores-murrieta Landsteiner Scientific S.A. de C.V. Mexico City Mexico Unidad de Investigación en Farmacología Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas Mexico City Mexico Departamento de Biología Celular Instituto Nacional de Perinatología Isidro Espinosa de los Reyes Mexico City Mexico Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina Instituto Politécnico Nacional Mexico City Mexico

The gastroesophageal reflux and/or peptic ulcer diseases are clinical conditions that occur usually accompanied of symptomatic pain. Lansoprazole, a proton pump inhibitor class drug is widely used in clinical practice for treatment of these diseases. However, its efficacy can be improved by combining with spasmolytic and/or visceral analgesic such as hyoscine butylbromide. Since hyoscine butylbromide is barely absorbed and exerts some local effects at gastrointestinal tract which may modify the absorption of lansoprazole, it is important to establish if there is a pharmacokinetic interaction after the oral concomitant administration of both drugs. For this objective, twenty-five subjects received under a crossover design an oral administration of lansoprazole (15 mg) plus placebo or a fixed-dose combination with hyoscine butiylbromide (15 mg + 10 mg, respectively). Plasma samples were obtained at different times during 10 hours. Lansoprazole plasma concentrations were determined by a high performance liquid chromatography method coupled to tandem mass spectrometry. Fixed-dose combination was well tolerated. Lansoprazole pharmacokinetic parameters were: Cmax 621.81 ± 212.79 and 450.38 ± 192.14 ng/mL;AUC0-t 1941.36 ± 845.57 and 1454.66 ± 757.28 ng·h/mL;tmax 2.83 ± 0.99 and 3.40 ± 1.82h;t1/2 1.35 ± 0.39 and 1.45 ± 0.51 h, for alone and combined fixed-dose formulation, respectively. Pharmacokinetic parameters were compared by analysis of variance and ratios of AUC0-t, Cmax and 90% confidence intervals obtained. Since confidence intervals exceed the 80% - 125% limits for these parameters, we conclude that there is a significantly pharmacokinetic interaction of lansoprazole when it is administered concomitantly with hyoscine butylbromide.

关键词： Lansoprazole Hyoscine Butylbromide Fixed-Dose Formulation Pharmacokinetic Interaction

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Leaching kinetics in cyanide media of Ag contained in the industrial mining-metallurgical wastes in the state of Hidalgo, Mexico

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International journal of Mining Science and Technology 2014年第5期24卷 689-694页

作者： juan Hernandez francisco Patino Isauro Rivera Iván Alejandro Reyes Misrael Uriel flores julio Cesar juarez Martín Reyes Research Centre in Materials and Metallurgy Autonomous University of Hidalgo Pachuca 42184 Mexico

The leaching kinetics in cyanide media of the silver contained in the Dos Carlos waste tailings at the City of Pachuca de Soto, Hidalgo State, Mexico were carried out. The used material contained the following chemical composition: 56 10-6of Ag, 0.6 10 6of Au and 70.43%(by weight) of SiO2; 7.032%(by weight) of Al2O3; 2.69%(by weight) of Fe; 0.46%(by weight) of Mn; 3.98%(by weight) of K2O; 3.34%(by weight) of CaO; 2.50%(by weight) of Na2O; 0.04%(by weight) of Zn; 0.026%(by weight) of Pb. The mineralogical phases present were the following: Silica, albite, argentite, berlinite, orthoclase, potassium jarosite, and natrojarosite. In the leaching kinetics in cyanide media, and under the studied conditions,the effect of the CN concentration on the reaction rate has no effect on the whole process of alkaline cyanidation, of which the reaction order is n 0. Temperature has an effect on the cyanidation rate of the reaction, with an activation energy of 47.9 Kj/mol. At the same time, when the particle size decreases there is an increase in the reaction rate, which is inversely proportional to the particle diameter; when increasing the NaOH concentration there is an increase in the reaction rate Kexp, with a reaction order(n) of 0.215 under the studied ranges.

关键词： Silver Waste tailings Cyanidation Leaching

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Fixed Dose Combination of Magaldrate Plus Domperidone Is More Effective than Domperidone Alone in the Treatment of Patients with Gastroesophageal Reflux Symptoms: A Randomized Double-Blind Study

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Pharmacology & Pharmacy 2014年第2期5卷 216-223页

作者： Shendel Nyx Rodríguez-Sánchez Héctor Isaac Rocha-González Cecilia Fernández del Valle-Laisequilla juan Rodríguez-Silverio francisco javier flores-murrieta juan Gerardo Reyes-García Productos Medix S.A. de C.V. México City Mexico Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina del Instituto Politécnico Nacional Mexico City Mexico Sección de Estudios de Posgrado e Investigación Escuela Superior de Medicina del Instituto Politécnico Nacional Mexico City Mexico Instituto Nacional de Enfermedades Respiratorias Secretaría de Salud Mexico City Mexico

Gastroeophageal reflux is a condition in which the acidified liquid content of the stomach backs up into the esophagus. The antiacid magaldrate and prokinetic domperidone are two drugs clinically used for the treatment of gastroesophageal reflux symptoms. However, the evidence of a superior effectiveness of this combination in comparison with individual drugs is lacking. A double-blind, randomized and comparative clinical trial study was designed to characterize the efficacy and safety of a fixed dose combination of magaldrate (800 mg)/domperidone (10 mg) against domperidone alone (10 mg), in patients with gastroesophageal reflux symptoms. One hundred patients with gastroesophageal reflux diagnosed by Carlsson scale were randomized to receive a chewable tablet of a fixed dose of magaldrate/domperidone combination or domperidone alone four times each day during a month. Magaldrate/domperidone combination showed a superior efficacy to decrease global esophageal (pyrosis, regurgitation, dysphagia, hiccup, gastroparesis, sialorrhea, globus pharyngeus and nausea) and extraesophageal (chronic cough, hoarseness, asthmatiform syndrome, laryngitis, pharyngitis, halitosis and chest pain) reflux symptoms than domperidone alone. In addition, magaldrate/domperidone combination improved in a statistically manner the quality of life of patients with gastroesophageal reflux respect to monotherapy, and more patients perceived the combination as a better treatment. Both treatments were well tolerated. Data suggest that oral magaldrate/domperidone mixture could be a better option in the treatment of gastroesophageal reflux symptoms than only domperidone.

关键词： Antiacid Domperidone Gastroesophageal Reflux Magaldrate Prokinetic

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Study of the Reactivity of (100) Felodipine Surface Model Based on DFT Concepts

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Open journal of Physical Chemistry 2019年第1期9卷 1-12页

作者： Carlos Tepech-Carrillo Roxana Licona-Ibarra j. francisco Rivas-Silva Antonio flores-Riveros Instituto de Física “Luis Rivera Terrazas” Benemérita Universidad Autónoma de Puebla Puebla México Facultad de Ciencias Químicas Benemérita Universidad Autónoma de Puebla Puebla Mexico

In this study, Density Functional Theory including a dispersion correction is employed to model and analyze the structural, electronic and local reactivity of the (100) surface of felodipine. The surface energy calculated at the Generalized Gradient Approximation (GGA) level, along with plane waves as basis set and ultrasoft pseudopotentials, shows that the (100) surface is the most stable as compared to the (010) and (110) ones. In particular, we have focused on performing a quantitative study of the reactivity of the surface by means of the Fukui function and through the HOMO and LUMO populations. Our results can be related to some applications in the pharmaceutical chemistry of this compound.

关键词： 1 4-Dihydropyridine Felodipine Density Functional Theory Fukui Functions

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Application of the Weibull Distribution to Estimate the Volume of Water Pumping by a Windmill

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journal of Power and Energy Engineering 2016年第9期4卷 36-51页

作者： M. Toledo Velázquez j. Herná ndez Rodrí guez M. Vega Del Carmen F. E. flores murrieta G. Tolentino Eslava Laboratorio de Ingenierí a Té rmica e Hidrá ulica Aplicada (LABINTHAP) IPN-SEPI-ESIME Zacatenco Ciudad de M&eacute xico M&eacute xico Divisió n de Ciencias e Ingenierí a Laboratorio en Sistemas de Energ&iacute a Universidad de Quintana Roo Chetumal M&eacute xico

Given the steady increase in use of alternative energy sources to supply part of the energy demand of the world, and considering that Mexico has enough wind resources to produce all the electricity required by the country, in this work, it is carried out the development of a system of wind resource assessment to determine the volume of water that a windmill pumping system can provide in a specific area. To this end, it has developed a computer program for wind resource assessment by measurements of wind speed, direction, temperature, barometric pressure and relative humidity. Measuring equipments were mounted in a wind measurement tower of 10 m high, within the premises of the University of Quintana Roo which is located along the coast. Until this day, there are records over a period of five months of the variables of wind speed, wind direction, temperature, relative humidity and atmospheric pressure. These variables were used for statistical calculations using the Weibull distributions. To give a better use of the calculated data, they were applied to the evaluation of a Pumping System.

关键词： Pumping Systems Weibull Distribution Wind Energy Windmill

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