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Journal of Biosciences and Medicines 2023年第11期11卷 23-32页

作者： evelyn pena Alfredo Inatti Xenón Serrano Martin Department of Clinical Research Industrias Biocontrolled C.A. Caracas República Bolivariana de Venezuela

Objectives: Evaluate the bioequivalence (BE) of two oral tablets formulations of diclofenac 150 mg in healthy male subjects under fasting condition. This was a phase I, randomized, open label, balanced, two period, two sequences, single oral dose, crossover, analyst blind study. Methods: Twenty four (24) healthy subjects were randomly assigned to one of two sequences protocol: 150 mg XR of reference formulation (R), diclofenac sodium in the first period or the test formulation (T), diclofenac potassium in the second or vice versa. The plasma concentrations were determined using a validated LC-MS/MS method. Pharmacokinetic (PK) parameters included: maximum plasma concentration (Cmax), area under the plasma concentration—time curve from time 0 to the last measurable concentration (AUC0-t), and area under the plasma concentration—time from time 0 to infinity (AUC0-∞), were evaluated for BE. Results: The results showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (90.43 - 107.17), AUC0-t (93.08 - 116.46) and AUC0-∞ (92.52 - 117.39) were within the BE (80% - 125%) acceptance range. Conclusions: Two formulations, reference product (R) Voltaren® (diclofenac sodium) of Novartis and test product (T), Diklason Bi (diclofenac potassium) of Laboratorios Leti S.A.V., with a single dose of 150 mg XR, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.

关键词： Bioequivalence Diclofenac Pharmacokinetics

Pharmacokinetics and Bioequivalence Evaluation of Two Rosuvastatin Calcium 20 mg Tablets: A Single Oral Dose, Randomized-Sequence, Open-Label, Two-Period Crossover Study in Healthy Volunteers under Fasting Conditions

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Journal of Biosciences and Medicines 2024年第6期12卷 230-243页

作者： evelyn pena Alfredo Inatti José Gregorio Chacón Department of Clinical Research Industrias Biocontrolled C.A. Caracas Venezuela

Objectives: To compare the rate and extent of absorption of Racor® 20 mg (Rosuvastatin calcium 20 mg) tablet of Laboratorios Leti, S.A.V., with Crestor® 20 mg (Rosuvastatin calcium 20 mg) tablet of AstraZeneca, UK Limited in healthy adult human subjects under fasting conditions. Method: This was an open label, analyst blind, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study in healthy, adult, human subjects under fasting condition. Twenty-four (24) subjects were planned as per the protocol and all subjects completed both periods of the study. The concentrations of Rosuvastatin in plasma were quantitated using a validated LC-MS/MS method of analysis and plasma levels were submitted for statistical analysis. Cmax, AUC0-t, AUC0-∞, Tmax, t1/2, Kel (hrs-1), percent AUC extrapolated [100 * (AUC0-∞ - AUC0-t)/AUC0-∞] (AUC_%Extrapobs) were calculated for rosuvastatin in plasma using SAS® version 9.1.3, SAS Institute. Inc. ***. ANOVA, 90% confidence interval using Schuirmann’s two one-sided test for bioequivalence, power and ratio analysis, for lntransformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ were computed and reported for Rosuvastatin in plasma for BE. Results: Data showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (95.01 - 112.66), AUC0-t (93.38 - 111.67) and AUC0-∞ (93.65 - 111.29) were within the BE (80% - 125%) acceptance range. Conclusions: Two products formulation, reference (R) Crestor® (rosuvastatin calcium) of AstraZeneca and test (T), Racor® (rosuvastatin calcium) of Laboratorios Leti S.A.V., with a single dose of 20 mg, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.

关键词： Bioequivalence Rosuvastatin Pharmacokinetics

Acyclovir-Loaded Solid Lipid Nanoparticles: A Permeation and Penetrability Study

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Journal of Biosciences and Medicines 2024年第10期12卷 316-327页

作者： Anyoli Taly Adriana Camino Cirana Rodriguez evelyn pena Alfredo Inatti Xenon Serrano Department of R&D Nanotechnology Laboratory Industrias Biocontrolled Grupo Leti S.A.V. Guarenas Venezuela Department of Clinical Research Industrias Biocontrolled Grupo Leti S.A.V. Guarenas Venezuela

Herpes simplex virus type I is a cutaneous infection treated with acyclovir. The topical treatment has therapeutic challenges due to the deficient delivery of the drug through epithelial barriers. This results in an inadequate drug-virus interaction in the basal epidermis (virus replication site). For this reason, it is essential to generate drug carrier systems that overcome these limitations. In this study, we evaluated the permeation (through in vitro test Franz cells) and penetration (by ex vivo test Tape Stripping) of a topical formulation of acyclovir loaded in solid lipid nanoparticles and a conventional formulation (Aciclor®). The acyclovir solid lipid nanoparticles were prepared using hot homogenization and sonication methods. The results yielded a particle size of 85 ± 2 nm, a polydispersity index of 0.24 ± 0.01, a zeta potential of −16 ± 2 mV, and 94% ± 3% of encapsulated drug. The in vitro test revealed that the permeability of acyclovir solid lipid nanoparticles formulation was superior compared to reference formulation, with values of 1473.74 ± 30.14 µg/cm2 for the solid lipid nanoparticles and 893.36 ± 38.09 µg/cm2 for the reference formulation. The ex vivo test demonstrated that acyclovir solid lipid nanoparticles exhibited superior penetrability through the stratum corneum compared to the reference formulation, with total amounts of 3767 µg for the solid lipid nanoparticles and 2162 µg for the reference formulation. These findings seem promising in advancing new effective therapies against herpes generated by herpes simplex virus type I.

关键词： Herpes Acyclovir Solid Lipid Nanoparticles Franz Cells Tape Stripping

Bioequivalence of Two Formulations of Metformin Hydrochloride 1000 mg XR Tablets, Fasting Condition in Healthy Adults Subjects

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Journal of Biosciences and Medicines 2024年第12期12卷 411-423页

作者： evelyn pena Alfredo Inatti Anyoly Taly José Chacón Xenon Serrano-Martin Clinical Research Industrias Biocontrolled C.A. Laboratorios Leti S.A.V. Guarenas Venezuela Research & Development Industrias Biocontrolled C.A. Laboratorios Leti S.A.V. Guarenas Venezuela Medical Department Megat Laboratories Quito Ecuador

Background: This study aimed to evaluate the bioequivalence of the two formulations of metformin 1000 mg XR tablets in healthy male volunteers under fasting conditions. Methods: This was a randomized, single-dose, open-label, two-period, two-sequence, crossover and single-dose study to compare the bioequivalence (BE) profile of Metformin (metformin hydrochloride) 1000 mg XR tablet of Laboratorios Leti S.A.V., with Glucophage® (metformin hydrochloride) 1000 mg XR tablet of Merck Serono GmbH in 26 adult healthy subjects. The pharmacokinetic (PK) parameters Cmax, AUC0−tand AUC0→∞were calculated based on the plasma drug concentration-time profile measured by liquid chromatography-mass spectrometry (LC-MS/MS). The safety was assessed throughout the study. The two formulations test (T) and reference (R) were considered bioequivalent if 90% confidence interval (CI) were within BE acceptance range of 80.00% - 125.00% for Cmax, AUC0−tand AUC0→∞. Results: A total of 25 subjects completed both study periods 90% confidence intervals (CIs) of the test/reference ratios were Cmax: 92.30% (89.08% - 96.97%), AUC0−t: 91.83% (87.11% - 94.11%) and AUC0→∞: 91.83% (87.23% - 94.85%) to metformin 1000 mg extended release. PK parameters were within the accepted bioequivalence criteria. The results show that no significant differences were observed between the pharmacokinetic profiles of the T and R formulations. No serious adverse events were reported in this study. Conclusion: The two formulations of metformin hydrochloride 1000 mg XR were bioequivalent in healthy subjects under fasting conditions.

关键词： Bioequivalence Metformin Pharmacokinetic

A Bioequivalence Study of Empagliflozin/Metformin Fixed-Dose Combination in Healthy Subjects under Fasting Conditions

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Journal of Biosciences and Medicines 2024年第9期12卷 235-250页

作者： evelyn pena Alfredo Inatti Anyoly Taly José Chacón Xenon Serrano-Martin Department of Clinical Research Industrias Biocontrolled C.A. Grupo Leti S.A.V. Guarenas Venezuela Department of Research & Development Industrias Biocontrolled C.A. Grupo Leti S.A.V. Guarenas Venezuela Department of Medical Megat Laboratories Quito Ecuador

Background: This study evaluated the bioequivalence of empagliflozin 12.5 mg/metformin 1000 mg tablets compared to Synjardy® (Empagliflozin 12.5 mg/metformin 1000 mg) tablets in healthy male subjects under fasting conditions. Methods: This was a phase I, randomized, single-dose, two-period, two-sequence, crossover study to evaluate the bioequivalence (BE) profiles of two fixed-dose combinations (FDCs) of empagliflozin/metformin. Cmax, AUC0-t and AUC0-∞ from test and reference formulations were evaluated to access BE. The plasma concentrations were measured using a validated liquid chromatography-mass spectrometry (LC-MS/MS) method. Of the 24 subjects enrolled, 23 completed both periods of the study. The two formulations test and reference were considered bioequivalent if 90% confidence interval (CI) fell within 80.00% - 125.00% for Cmax, AUC0-t and AUC0-∞. Tolerability and safety were assessed throughout the study. Results: The pharmacokinetic (PK) parameters were similar between the test product (T) and reference product (R) Synjardy®. The 90% CI of the test/reference ratios of log-transformed PK parameters point estimates was Cmax: 89.87% (85.68% - 94.27%), AUC0-t: 87.91% (83.65% - 92.39%) and AUC0-∞: 87.16% (82.80% - 91.75%) to empagliflozin and Cmax: 92.19% (87.95% - 96.65%), AUC0-t: 91.38% (84.42% - 98.91%) and AUC0-∞: 93.78% (83.82% - 104.93%) to metformin respectively (90% CI for all PK parameters fell within 80.00% - 125.00%). Conclusion: Our results demonstrated BE between the test and reference formulations of oral tablets of empagliflozin 12.5 mg/metformin 1000 mg (FDC) in healthy male subjects under fasting conditions.

关键词： Bioequivalence Fix Dose Combinations Pharmacokinetic Empagliflozin

Liposomes Carrying Diclofenac Diethylammonium: A Penetrability and Permeation Study

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Journal of Biosciences and Medicines 2024年第12期12卷 206-218页

作者： Adriana Camino Anyoli Taly Cirana Rodriguez Alfredo Inatti evelyn pena Xenon Serrano Department of R & D Nanotechnology Laboratory Industrias Biocontrolled Grupo Leti S.A.V. Guarenas Venezuela Department of Clinical Research Industrias Biocontrolled Grupo Leti S.A.V. Guarenas Venezuela

This study investigated whether liposomes could enhance the permeation and penetration of diclofenac diethylammonium. For this, a 1.16% diclofenac diethylammonium liposome gel formulation was developed (Grupo Leti, S.A.V.). In vitro and ex vivo tests were conducted to analyze the diffusion and penetration profiles of the formulation. The profiles obtained were compared with a commercially available product, DiAnalper gel (Pharmetique Labs). The in vitro test was assessed in a Franz diffusion cell system using a dialysis membrane. The cumulative amount of drug permeated after 24 h demonstrated a significantly (p 2, whereas the commercial formulation yielded values of 371.00 ± 3.54 μg/cm2. These findings were further supported by consistent results in the percentage of drug release, flux, and permeability coefficient, all indicating a notable improvement in diffusion associated with the liposomal gel formulation. The tape stripping assay performed on pig ear skin demonstrates a statistically significant difference (p < 0.05) between the penetration transport of the diclofenac from liposome gel formulation (1413.95 ± 250.51 μg) and the conventional product (202.36 ± 18.07 μg) the liposomal formulation was able to cross de stratum corneum and deliver a high amount of drug to the skin. These findings demonstrated that incorporating diclofenac into a liposomal system significantly improved the drug delivery, which could confer an advantage for clinical uses.

关键词： Liposomes Diclofenac Diethylammonium Transdermal Drug Delivery Skin Permeation Skin Penetration

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国际盆景协会佳作选登(十)

花木盆景 2025年第1期 74-75页

作者：陈昌 [韩国]Jeong I Seuk [美国]Ryan Neil [菲律宾]Mike pena 不详

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Temporal aiming

Light(Science & Applications) 2020年第1期9卷 741-752页

作者： Victor Pacheco-pena Nader Engheta School of Mathematics Statistics and PhysicsNewcastle UniversityNewcastle Upon Tyne NE17RUUK Department of Electrical and Systems Engineering University of PennsylvaniaPhiladelphiaPA 19104USA

Deflecting and changing the direction of propagation of electromagnetic waves are needed in multiple applications,such as in lens-antenna systems,point-to-point communications and *** this realm,metamaterials have been demonstrated to be great candidates for controlling wave propagation and wave-matter interactions by offering manipulation of their electromagnetic properties at *** have been studied mainly in the frequency domain,but their temporal manipulation has become a topic of great interest during the past few years in the design of spatiotemporally modulated artificial *** this work,we propose an idea for changing the direction of the energy propagation of electromagnetic waves by using time-dependent metamaterials,the permittivity of which is rapidly changed from isotropic to anisotropic values,an approach that we call temporal *** so doing,here,we show how the direction of the Poynting vector becomes different from that of the *** scenarios are analytically and numerically evaluated,such as plane waves under oblique incidence and Gaussian beams,demonstrating how proper engineering of the isotropic-anisotropic temporal function of ε_(r)(t)can lead to a redirection of waves to different spatial locations in real time.

关键词： anisotropic wave oblique

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迷失丛林 Sonora鸡尾酒吧

室内设计与装修 2025年第1期 148-149页

作者：无 Ricard Fabregat Rafaela Aranzaens Michele Soares Yesica pena Maria di Bello Adria Goula(摄影) 夏花(编译) EL EQUIPO CREATIVO 不详

Sonora鸡尾酒吧位于阿姆斯特丹Nhow酒店的顶层。其三角形的布局让空间更显紧凑,由OMA建筑事务所及建筑师RemKoolhaas设计的落地玻璃幕墙,提供了欣赏阿姆斯特丹新区壮丽景观的机会。设计师面临的挑战在于,要如何让鸡尾酒吧在与这些美景... 详细信息

Sonora鸡尾酒吧位于阿姆斯特丹Nhow酒店的顶层。其三角形的布局让空间更显紧凑,由OMA建筑事务所及建筑师RemKoolhaas设计的落地玻璃幕墙,提供了欣赏阿姆斯特丹新区壮丽景观的机会。设计师面临的挑战在于,要如何让鸡尾酒吧在与这些美景的竞争中脱颖而出。

关键词：建筑事务所玻璃幕墙阿姆斯特丹鸡尾酒建筑师三角形酒店

An Architecture for Software Engineering Gamification

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Tsinghua Science and Technology 2020年第6期25卷 776-797页

作者： Oscar Pedreira Felix Garcia Mario Piattini Alejandro Cortinas Ana Cerdeira-pena the Universidade da Coruna Centro de Investigacion CITICLaboratorio de Bases de DatosFacultade de InformaticaElvinaA Coruna15071Spain the Universidad de Castilla-La Mancha Grupo AlarcosEscuela Superior de InformaticaPaseo de la Universidad4Ciudad Real13071Spain.

Gamification has been applied in software engineering to improve quality and results by increasing people’s motivation and engagement.A systematic mapping has identified research gaps in the field,one of them being the difficulty of creating an integrated gamified environment comprising all the tools of an organization,since most existing gamified tools are custom developments or *** this paper,we propose a gamification software architecture that allows us to transform the work environment of a software organization into an integrated gamified environment,i.e.,the organization can maintain its tools,and the rewards obtained by the users for their actions in different tools will mount *** developed a gamification engine based on our proposal,and we carried out a case study in which we applied it in a real software development *** case study shows that the gamification engine has allowed the company to create a gamified workplace by integrating custom-developed tools and off-the-shelf tools such as Redmine,TestLink,or JUnit,with the gamification *** main advantages can be highlighted:(i)our solution allows the organization to maintain its current tools,and(ii)the rewards for actions in any tool accumulate in a centralized gamified environment.

关键词： gamification software engineering gamification architecture gamification engine