1. Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy „Iuliu Haţieganu”, Cluj-Napoca, Romania
2. Clinical Pharmacology and Pharmacokinetics Department, Terapia S.A – a Sun Pharma Company, Cluj-Napoca, Romania
3. Department of Pharmaceutical Botany, Faculty of Pharmacy, University of Medicine and Pharmacy „Iuliu Haţieganu”, Cluj-Napoca, Romania
4. Clinical Pharmacology and Pharmacokinetics Department, Gurugram, India
Objective: The aim of the present study was to evaluate the relative bioavailability of two formulations containing 10 mg dapagliflozin in healthy Caucasian subjects under fasting conditions.
Materials and Methods: Forty-eight healthy Caucasian subjects were enrolled in a single-dose, crossover, balanced, open label, randomized clinical trial, with two treatment, two periods and two sequences. The wash-out period was of 7 days and thirty-eight subjects completed both study periods. Each subject received a single dose of 10 mg dapagliflozin as the reference product Farxiga® (AstraZeneca Pharmaceuticals LP, USA) and the test product developed by Sun Pharmaceutical Industries, India. Dapagliflozin plasma levels were determined from blood samples collected in both study periods before and after dosing until 48 hours by using a validated LC-MS/MS method. For pharmacokinetic analysis of data, the non-compartmental method was used (Phoenix® WinNonlin 6.3). The statistical analysis was performed by SAS software 9.1.3 for the logarithmically transformed values of maximum plasma concentration and area under the curve.
Results: The 90% confidence intervals for the evaluated pharmacokinetic parameters were found to be in the accepted interval for bioequivalence (80.00-125.00%).
Conclusion: The 10 mg dapagliflozin immediate release tablet newly developed by Sun Pharmaceutical Industries, India, is bioequivalent with the reference product Farxiga® under fasted state of the subjects.
1. Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Pharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
3. Pharmaceutical Chemistry Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
Objective: The compatibility of four binary active substances combinations adapalene – levofloxacin (ADP-LFX), adapalene – miconazole nitrate (ADP-MCZ), levofloxacin – meloxicam (LFX-MLX) and levofloxacin – miconazole nitrate (LFX-MCZ) was analysed to be comprised in new transdermal therapeutic systems. Also, the compatibility of selected active substances and four polymeric excipients (hydroxypropyl methylcellulose – HPMC 15000, hydroxypropyl methylcellulose – HPMC E5, ethyl cellulose – EC 10, and hydroxyethyl cellulose – HEC) was studied.
Methods: Thin layer chromatographic method (TLC) and four selected mobile phases were used. On the plate (in situ) were obtained the binary combinations (active substances and active substance-polymer).
Results: A good compatibility of ADP-LFX was found using ammonia : methanol : acetonitrile : methylene chloride 2:4:1:4 mobile phase. Using chloroform : acetone : glacial acetic acid 34:4:3 on the chromatogram of ADP-MCZ, only ADP spots appeared but without changes in the shape of the spots and Rf values. Any modifications of LFX and MLX spots (from LFX-MLX mixture) had been observed using toluene : glacial acetic acid : methanol 11:1:0.5 mobile phase, although LFX spots have remained on the baseline. Only LFX spots were visible from LFX-MLX and LFX-MCZ mixtures (ammonia : methanol : acetonitrile : methylene chloride 2:4:1:4 mobile phase). Distinctive spots were observed for ADP, LFX and MLX with variable results from no chemical interactions to limited chemical interactions when the compatibility with polymers was verified.
Conclusions: ADP-LFX and LFX-MLX mixtures were found to be compatible. ADP with HPMC polymers and LFX with HPMC E5 and HEC had presented excellent compatibility; for the other binary combinations, different analytical methods will be necessary.
Melania Macarie1, Simona Maria Bataga1, Monica Pantea1, Razvan Opaschi1, Simona Mocan2, Ioan Macarie3
1. Department of Gastroenterology. George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Department of Pathology, Targu Mures County Clinical Emergency Hospital, Romania
3. Department of Internal Medicine, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
Objective: This study aims to determine the correlation between risk factors and erosive esophagitis development. Methods: We conducted a retrospective observational study on a consecutive series of 19.672 patients who underwent upper gastrointestinal endoscopy between 01.01.2011-31.12.2017. A total of 3005 patients, diagnosed with erosive esophagitis, were included in the present study and stratified according to Los Angeles classification. Results: During the studied period we found 3005 patients with erosive esophagitis, sex ratio male to female was 1.3/1, the most common forms of esophagitis being grade A and B: 74.54% patients with esophagitis grade A, 14.80% patients with grade B; 5.29% patients were with grade C and 5.35% patients with esophagitis grade D. In severe esophagitis the male predominance was more prevalent (249 males, 71 female), with a sex ratio 3.50/1. The correlation of male gender with severe esophagitis was highly statistically significant (p < 0.0001, OR 2.97; 95% CI 2.25-3.91). Hiatal hernia was diagnosed in 1171 patients, the presence of large hiatal hernias, being an important predictor, with statistical significance (p < 0.0001, OR 3.41; 95% CI 2.22-5.21), for severe esophagitis development. Incidence of Helicobacter pylori infection was 11.51%, in the entire study group, with no statistical significant difference between patients with mild or severe esophagitis (12.02% vs 7.18%). Conclusion: Erosive esophagitis is a frequent disease, the most common forms being grade A and B. Male gender and the presence of hiatal hernia are the most important risk factors for erosive esophagitis development, in our study group.
1. Department of Epidemiology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. County Emergency Clinical Hospital, Targu Mures, Romania
With acne as one of the most common and frequent conditions of young adult patients, we looked for significant associations, associated conditions with influence on the skin condition with the idea of outlining a different approach of the acne patient. With a multifactorial, multidisciplinary etiopathogeny, the purpose of this study was to highlight the factors involved in the pathogenesis of this condition and to identify those that should be taken into account when prescribing the treatment.
1. Institute of Legal Medicine, Tirgu Mures, Romania
2. County Emergency Clinical Hospital, Tirgu Mures, Romania
Objective: The main objective of this study is to evaluate the medico-legal aspects of fatal road traffic accidents.
Methods: This is a retrospective study consisting of 80 forensic autopsies performed at the Institute of Legal Medicine – Tîrgu Mureș, Romania during a two years period, between January 1st, 2016 to December 31st, 2017. The information obtained was based on the medical records and the evaluation of autopsy reports.
Results: Male victims involved in road traffic accidents were nearly three times more numerous than women (72.5% vs. 27.5%). Divided into 3 age groups (under 35 years old, 36-59 years old and over 60 years old) we noticed a relatively uniform distribution of the victims, with a slight dominance of the 36-59 age group and the over 60 years of age group. The highest number of victims was among the pedestrians (36.25%), followed in decreasing order by the drivers (33.75%), passengers (17.5%), cyclists (7.5%) and motorcyclists (5%). Positive alcohol testing was found in 14 of drivers (81 %). The analysis of lesions found during necropsies of the deceased at the scene of the accident highlights some particularly life-incompatible injuries that resemble any rescue effort on the part of the medical crew moved to the scene of the accident.
Conclusion: Inappropriate road conditions and indiscipline in traffic of both drivers and pedestrians contribute to unacceptably high mortality.
Irina-Bianca Kosovski1, Dana-Valentina Ghiga2, Monica Tarcea3, Cristina Nicoleta Ciurea4, Ana Ioana Savin5, Anca Bacârea6
1. Clinical laboratory Department of Emergency Clinical County Hospital of Târgu Mures, Romania
2. Research Methodology Department, University of Medicine, Pharmacy, Science and Technology of Târgu Mures, Romania
3. Community Nutrition and Food Safety Department, University of Medicine, Pharmacy, Science and Technology of Târgu Mures, Romania
4. Microbiology, virology and parasitology Department, University of Medicine, Pharmacy, Science and Technology of Târgu Mures, Romania
5. Pathology Department, Colentina University Clinical Hospital, Bucharest, Romania
6. Pathophysiology Department, University of Medicine, Pharmacy, Science and Technology of Târgu Mures, Romania
Objective: The study aims to analyze obesogenic behavioral patterns of adolescents living in Mureş County, Romania, as well as to establish a relationship between these behaviors and their Body Mass Index (BMI), in an attempt to provide effective prevention strategies for obesity.
Material and Methods: 153 students between 9th to 12th grade, aged between 14 and 19 years old, from the Vocational and Art Highschool of Târgu Mureş were included in the study. All the candidates filled out an evaluation questionnaire of lifestyle and risky behaviors. The analyzed data were sex, age, residence, BMI and risky eating behavior defined as the consumption of carbohydrates (bread, potatoes, sweets), sodas, junk food, alcohol (wine, distilled beverages, beer), beer separately, level of physical activity (school and extra-school sports activities), sedentary behaviors (≥2 hours/day in front of a screen: personal computer-PC and television-TV), and spending ≥2 hours/day separately on the PC and on the TV.
Results: A statistically significant association was observed between BMI and consumption of fast-food, tobacco, beer, sedentary behavior and spending ≥2 hours/day in front of the PC. Moreover, there was a statistically significant difference between the BMI values of adolescents presenting all studied risk behaviors compared to those who did not.
Conclusions: Obesity among adolescents from Mureș County is influenced by lifestyle choices like fast-food, tobacco, beer, sedentary behavior and spending ≥2 hours/day in front of the PC.
1. Periodontological Department, Faculty of Dentistry, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania
2. Orthodontic Department, Faculty of Dentistry, University of Medicine, Pharmacy, Science and Technology of Targu Mures, Romania
3. Orthodontic Department, Faculty of Dentistry, University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca, Romania
Introduction: The orthodontic treatment helps in reestablishing a functional occlusion, improving the aesthetics and functionality of the dento-facial complex. A correct alignment of the teeth, through the correction of some dental or skeletal anomalies, enhances the possibilities of dental hygiene, thus reducing the risk of periodontal affections. Nevertheless, the presence of orthodontic appliances in the oral cavity may reduce the efficacy of the means of oral hygiene by creating retentive areas for food, thus producing damages at the level of the marginal periodontium.
Objective: The evaluation of oral hygiene practices for patients in the course of fixed orthodontic therapy and the identification of changes appeared at the level of the marginal periodontium caused by the orthodontic appliances.
Material and methods: A questionnaire with 20 questions was distributed to a number of 129 patients undergoing the active phase of orthodontic treatment in the Orthodontic and Dentofacial Clinic of the Medical Dental School Tîrgu Mureș or in some private practices in the Bucharest metropolitan area.
Results: The majority of patients surveyed are aware of the means of dental hygiene and practice a daily brushing, associated with auxiliary means. The iatrogenic effects of the fixed therapy are represented by gingival recession, gingival overgrowth and bleeding during brushing but these were visible only in the case of a small number of patients.
Conclusions: The fixed orthodontic treatment must be started only after a thorough evaluation of the marginal periodontium, with a close orthodontist – periodontist collaboration and avoidance of jiggling-like movements.
Claudia Floriana Suciu, Andreea Varga, Corneliu Florin Buicu, Ioan Tilea
University of Medicine, Pharmacy, Science and Technology of Targu Mures, Romania
Objective: Our study aimed to validate the neutrophil-to-lymphocyte ratio (NLR) as a marker for aortic arch calcification in hypertensive patients with less advanced chronic kidney disease (CKD).
Methods: A number of forty-four hypertensive patients with chronic kidney disease (categories G3a and G3b – 2012 KDIGO nomenclature) were included in the study. Considering the presence of aortic arch calcification (AAC) on chest X-ray, the study population was divided into two groups: 27 patients AAC present and seventeen without aortic arch calcification. Laboratory data were collected for each patient and NLR was computed. Comorbidities were also recorded: stable coronary artery disease, lower extremity arterial disease and hypertensive heart disease.
Results: A positive correlation between neutrophil-to-lymphocyte ratio and aortic arch calcification in hypertensive CKD patients was identified. Furthermore, advanced age, increased alkaline phosphatase and increased erythrocyte sedimentation rate had a positive association with aortic arch calcification. We found no statistical correlation between neutrophil-to-lymphocyte ratio and other laboratory features in both groups of patients.
Conclusions: Neutrophil-to-lymphocyte ratio may be viewed as a potential risk factor for vascular calcification in patients with moderate chronic kidney disease; nevertheless, future extensive studies are necessary. In the management of hypertensive patients, general medicine might particularly benefit of this simple, readily available inflammatory marker.
Amalia Abageru, Mihai Pop, Monika Kovács, Alexandra Stoica, Monica Monea
University of Medicine and Pharmacy Science and Technology of Targu Mures, Romania
Objective: The aim of our study is to compare the ability of two nickel-titanium systems that use different rotation motions to create preparations that could promote a complete filling of the apical third of root canals.
Methods: We used 36 freshly extracted teeth, randomly divided in two groups, as follows: in Group A we used ProTaper Next, a system characterized by a continuous rotary motion and in Group B the teeth were instrumented with Wave-One, in which the files have a reciprocating motion. All teeth were root filled based on the same protocol, using gutta-percha and AH Plus. The teeth were further prepared for microleakage evaluation based on dye penetration technique, as follows: immersion in 2% methylene blue, longitudinally sectioned and examination of the apical thirds with an operating microscope. The distance of dye penetration along dentin walls was measured using the ImageJ program.
Results: The comparison between rotational and reciprocating systems showed that reciprocating files significantly promoted a reduced apical microleakage, as demonstrated by unpaired t test, Welch corrected (p=0.0346).
Conclusion: The use of Wave-One Reciprocating system was considered more effective in the shaping of root canals, as they demonstrating better conditions for the hermetic, tridimensional sealing of apical third of the roots canals.
Ioana Todor1, Adina Popa2, Dana Muntean1, Maria Neag3, Ana-Maria Gheldiu4, Corina Briciu2, Daniel Leucuta5, Laurian Vlase1
1. University of Medicine and Pharmacy “Iuliu Hatieganu”, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, Romania
2. University of Medicine and Pharmacy “Iuliu Hatieganu”, Faculty of Pharmacy, Department of Clinical Pharmacy, Cluj-Napoca, Romania
3. University of Medicine and Pharmacy “Iuliu Hatieganu”, Faculty of Medicine, Department of Pharmacology, Toxicology and Clinical Pharmacology, Cluj-Napoca, Romania
4. University of Medicine and Pharmacy “Iuliu Hatieganu”, Faculty of Pharmacy, Department of Pharmaceutical Botany, Cluj-Napoca, Romania
5. University of Medicine and Pharmacy ”Iuliu Hatieganu”, Faculty of Medicine, Department of Medical Informatics and Biostatistics, Cluj-Napoca, Romania
Objective: The present research aimed to investigate whether a pharmacokinetic drug interaction exists between atomoxetine, a substrate of CYP2D6 and duloxetine, an enzymatic inhibitor of the same metabolic pathway.
Methods: Twenty-three healthy volunteers were enrolled in an open-label, non-randomized, sequential, 2-period clinical study. During the trial, they received a single dose of atomoxetine 25 mg (Period 1:Reference) followed by a combination of atomoxetine 25 mg and duloxetine 30 mg, after a pretreatment regimen with duloxetine 30-60 mg/day for 4 days (Period 2:Test). The pharmacokinetic parameters of atomoxetine and its main metabolite (4-hydroxyatomoxetine-O-glucuronide) were estimated using a non-compartmental approach and statistical tests were used to compare these parameters between study periods.
Results: A total of 22 subjects, extensive metabolizers (EMs), were considered for the final report of the study findings. Duloxetine influenced the plasma concentration-time profile of both parent drug and its glucuronidated metabolite. The pharmacokinetic and statistical analysis revealed that pretreatment with the enzymatic inhibitor increased the mean atomoxetine AUC0–t (from 1151.19±686.52 to 1495.54±812.40 [ng*h/mL]) and AUC0–∞ (from 1229.15±751.04 to 1619.37±955.01 [ng*h/mL]) while kel was decreased and the mean t1/2 was prolonged. With regard to 4-hydroxyatomoxetine-O-glucuronide, Cmax was reduced from 688.76±270.27 to 621.60±248.82 [ng/mL] after coadministration of atomoxetine and duloxetine.
Conclusions: Duloxetine had an impact on the pharmacokinetics of atomoxetine as it increased the exposure to the latter by ~30%. Although the magnitude of this pharmacokinetic interaction is rather small, a potential clinical relevance cannot be ruled out with certainty without further investigation.
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