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

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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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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Cucurbita ficifolia Bouché Regulates the Metabolism of Carbohydrates and Lipids in Liver by Activation of PPARα without Affectation on PPARγ in Vivo and in Vitro

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American Journal of Plant Sciences 2023年第7期14卷 763-781页

作者： Julio Cesar Almanza-Perez Vladimir Hernandez-Rosado Angeles Fortis-Barrera Gerardo Blancas-flores Edgar Alarcon-Villaseñor Jose Luis flores-Saenz Wendoline Rosiles-Alanis francisco javier Alarcon-Aguilar Pharmacology Laboratory Department of Health Sciences Division of Biological and Health Sciences Metropolitan Autonomous University Mexico City Mexico Adyderma Medical International Institute Mexico City Mexico

Diabetes mellitus control in Mexico is practiced by using antidiabetic agents and, by empirical way using medicinal plants. Cucurbita ficifolia (C. ficifolia) has been attributed with hypoglycemic, hypotriglyceridemic, and anti-inflam- matory effects, and D-chiro-inositol (DCI), 4-hydroxybenzoic acid, and β-sitosterol were proposed as active principles. The last two compounds were suggested as activators of two transcription factors, PPARα and PPARγ, in C2C12 myocytes, which participate in β-oxidation of fatty acids and insulin sensitivity. However, the involvement of the hepatocytic and adipocytic PPARs in the effects of C. ficifolia has not yet been explored. This research aimed to determine the effects of C. ficifolia on PPARα, PPARγ, and inflammatory cytokines in streptozotocin (STZ)-induced diabetes mice, HepG2 hepatocytes and 3T3-L1 adipocytes, implicating two additional cell types associated with metabolism of carbohydrates and lipids. STZ-induced diabetes mice received C. ficifolia (200 mg/kg/day) for 30 days, measuring serum cytokines (TNF-α and IL-6). RNA was extracted from liver. Besides, HepG2 and 3T3-L1 cells were incubated (24 h) with C. ficifolia (0.078 mM DCI), using pioglitazone or fenofibrate as controls. RNA was also extracted from cells and PCR in real-time was performed to determinate PPARα and PPARγ expression. In diabetic animals, C. ficifolia decreased glycemia and body weight, decreasing the expression level of TNF-α and IL-6. In addition, C. ficifolia increased PPARα expression in liver of diabetic animals, in HepG2 and 3T3-L1 cells;PPARγ expression only significantly increased in HepG2 cells. The data suggest that the effects on the glycemia and lipids of C. ficifolia and its anti-inflammatory effects imply, besides skeletal muscle cells, hepatic and adipocytic PPARα activation, without affectation on PPARγ. PPARs regulation by C. ficifolia may improve the metabolic dysfunctions associated with metabolic disease, controlling the intake, activation, and oxidation of fatty acids and lipid

关键词： Cucurbita ficifolia Diabetes Mellitus Hypoglycemic Plants Anti-Inflammatory Plants PPARs PPARα

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mRNA levels of TLR4 and TLR5 are independent of H pylori

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World Journal of Gastroenterology 2008年第34期14卷 5306-5310页

作者： Elvira Garza-González Virgilio Bocanegra-García francisco javier Bosques-Padilla Juan Pablo flores-Gutiérrez francisco Moreno Guillermo Ignacio Perez-Perez Departmento de Microbiología Facultad de MedicinaUniversidad Autónoma de Nuevo León Departmento de Biología Molecular y Bioingeniería UAM Reynosa Aztlán Universidad Autónoma de Tamaulipas Hospital Universitario "Dr. José Eleuterio González" Universidad Autónoma de Nuevo León Department of Medicine and Microbiology New York University School of Medicine

AIM:To determine if the presence H pylori or its viru- lence affect toll-like receptor 4 (TLR4) and TLR5 mRNA expression levels. METHODS:For the in vivo assays, gastric biopsies were obtained from 40 patients and H pylori status was determined. For the in vitro assays, human gastric adenocarcinoma mucosal cells (AGS) were cultured in the presence or absence of twelve selected H pylori strains. H pylori strains isolated from culture-positive patients and selected strains were genotyped for cagA and vacA. The cDNA was obtained from mRNA extracted from biopsies and from infected AGS cells. TLR4 and TLR5 mRNA levels were examined by real-time PCR. RESULTS: The presence of H pylori did not affect the mRNA levels of TLR4 or TLR5 in gastric biopsies. The mRNA levels of both receptors were not influenced by the vacA status (P > 0.05 for both receptors) andthere were no differences in TLR4 or TLR5 mRNA levels among the different clinical presentations/histological fi ndings (P > 0.05). In the in vitro assay, the mRNA levels of TLR4 or TLR5 in AGS cells were not influenced by the vacAs1 status or the clinical condition as-sociated with the strains (P > 0.05 for both TLR4 and TLR5). CONCLUSION: The results of this study show that the mRNA levels of TLR4 and TLR5 in gastric cells, both in vivo and in vitro, are independent of H pylori colonization and suggest that vacA may not be a significant player in the first step of innate immune recognition mediated by TLR4 or TLR5.

关键词：幽门杆菌 TLR4 TLR5 胃腺癌黏膜细胞 mRNA

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Forecast of the Luminescent Phenomena of Silicon Rich Oxide Films off Stoichiometry by Means of the Global Reaction Model

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Journal of Modern Physics 2015年第11期6卷 1679-1694页

作者： Néstor David Espinosa-Torres José álvaro David Hernández de la Luz José francisco javier flores-Gracia José Alberto Luna-López javier Martínez-Juárez Gregorio flores-Carrasco IC-CIDS Benemérita Universidad Autónoma de Puebla Puebla México Ex Graduate Research Trainee at Plasma Processing Laboratory Chemical Engineering Department McGill University Montreal Canada Department of Materials Science and Engineering and Chemical Engineering University Carlos III of Madrid and IAAB Madrid Spain

The Global Reaction Model describes a set of chemical reactions that can potentially occur during the process of obtaining silicon rich oxide (SRO) films, regardless of the technique used to grow such films which are an outside stoichiometry material. Particularly, chemical reactions that occur during the process of growing of SRO films by LPCVD technique are highlighted in this model. We suggest and evaluate either some types of molecules or resulting nanostructures and we predict theoretically, by applying the density functional theory, the contribution that they may have to the phenomenon of luminescence which is measured in SRO films. Also, we have calculated the opto-electronic properties of SRO films. The suggested model provides enough information required to identify the molecular structures resulting from the presence of defects in SRO films and also those corresponding to charged structures. It is also possible to detect the molecular structures which are modified due to the effect of heat treatment, and identify the presence of different oxidation states inclusive the formation of siloxanes.

关键词： Global Reactions Model Silicon Rich-Oxide Defects LPCVD Luminescence

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Laparoscopic approach in gastrointestinal emergencies

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World Journal of Gastroenterology 2016年第9期22卷 2701-2710页

作者： Rosa M Jimenez Rodriguez Juan José Segura-Sampedro Mercedes flores-Cortés francisco López-Bernal Cristobalina Martín Verónica Pino Diaz Felipe Pareja Ciuro javier Padillo Ruiz Department of Surgery Hospital Universitario Virgen del Rocio 41013 Sevilla Spain Hospital Universitario Son Espases 07010 Palma de Mallorca Spain

This review focuses on the laparoscopic approach to gastrointestinal emergencies and its more recent indications. Laparoscopic surgery has a specific place in elective procedures, but that does not apply in emergency situations. In specific emergencies, there is a huge range of indications and different techniques to apply, and not all of them are equally settle. We consider that the most controversial points in minimally invasive procedures are indications in emergency situations due to technical difficulties. Some pathologies, such as oesophageal emergencies, obstruction due to colon cancer, abdominal hernias or incarcerated postsurgical hernias, are nearly always resolved by conventional surgery, that is, an open approach due to limited intraabdominal cavity space or due to the vulnerability of the bowel. These technical problems have been solved in many diseases, such as for perforated peptic ulcer or acute appendectomy for which a laparoscopic approach has become a wellknown and globally supported procedure. On the other hand, endoscopic procedures have acquired further indications, relegating surgical solutions to a second place; this happens in cholangitis or pancreatic abscess drainage. This endoluminal approach avoids the need for laparoscopic development in these diseases. Nevertheless, new instruments and new technologies could extend the laparoscopic approach to a broader array of potentials procedures. There remains, however, a long way to go.

关键词： Minimally invasive surgery Gastrointestinal surgery Emergency surgery Digestive emergencies Abdomina

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