Category Archives: Original Research

Unified protocols for transdiagnostic treatment versus the Beckian’s approach of cognitive behavioral therapy for medical students with emotional disorders

Cosmin O. Popa1, Peter Olah2, Cristiana Cojocaru3, Zsolt Jakab3, Dana V. Ghiga4, Alina Schenk3

1. Department of Ethics and Social-Sciences, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Department of Medical Informatics and Biostatistics, Faculty of Medicine, University of Medicine and Pharmacy of Tirgu Mures, Romania
3. The Doctoral School of Medicine and Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
4. Department of Research methodology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2022-0002

Background: Emotional disorders are highly prevalent among medical students, impacting their academic performance and general quality of life. It was shown that cognitive-behavioral and emotion regulation strategies are efficient for reducing anxiety and depressive symptoms in young people.
Objective: This study aims to compare the efficiency of standard individual Cognitive-Behavioral Therapy (CBT) to a group intervention based on the Unified Protocol for Transdiagnostic Treatment (UPTT) of emotional disorders in two groups of medical students with similar baseline characteristics.
Method: The sample of this research was composed of 64 medical students in total, of which 34 were included in the CBT group (Mage= 19.5 years, SD= 0.96) and 30 were included in the UPTT group (Mage= 19.4 years, SD= 0.93). The level of irrational beliefs and emotional distress were measured before and after the interventions, which were carried out by certificated psychotherapists.
Results: Statistically significant differences were observed between pre-test and post-test in both groups. The level of irrational beliefs dropped after the CBT (M=62.91, SD=21.30, p<0.05) and the UPTT intervention (M=67.33, SD=34.89, p<0.05), respectively. Similarly, the profile of emotional distress changed after the CBT (M=77.62, SD=16.97, p<0.05) and the UPTT intervention (M=68.77, SD=20.06, p<0.01).
Conclusion: Psychological interventions relying on cognitive-behavioral approaches, including standard, individual psychotherapy and a group intervention designed according to a transdiagnostic protocol, are suitable methods for reducing emotional disorders among medical students.

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Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration

M Vivek Reddy1, GNK Ganesh1, B Babu2, Ramesh Jagadeesan3, Praharsh Kumar MR4

1. Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.
2. Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.
3. Department of Analytical and Product development. Recipharm Pharmaservices, Bangalore, Karnataka-560002, India.
4. Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.

DOI: 10.2478/amma-2022-0004

Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. The aim of the present study is to find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits.
Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FMECA (Failure mode, Effects and Criticality Analysis).
Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval.
Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.

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Study of the anxiolytic effect of propranolol and dextromethorphan in mice using a model of psychogenic stress

Radion Garaz, Sorina Cucuiet, Gabriela Garaz-Pislariu, Raluca-Ioana Buliga

1. George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2021-0034

Objective: To find the anxiolytic effects in a psychogenic stress model in mice, the present study has investigated the interaction between propranolol and dextromethorphan.
Methods: 50 Albino Swiss male mice were housed in groups of 10 per cage. The beta-adrenergic receptor blocker propranolol (20 mg/kg bw), the N-methyl-D-aspartate (NMDA) receptor dextromethorphan (30 mg/kg bw), and their combination were administered 10 minutes after exposure to predator odor. The treatments included diazepam as positive control and normal saline as negative control. Anxiety-like behaviors were evaluated using the elevated plus-maze test (EPM) 7 days after stress induction.
Results: Regarding the length of stay (F=25.53; p<0.0001)/ number of entries in the open arms (F=3.533; p=0.0416), time (F=6.127; p=0.0045)/ number of entries in the closed arms (F=5.690; p=0.0141), time in center-point (F=3.577; p=0,0295), and total distance traveled (F= 4.711; p=0.0145), there was a significant difference among the treated groups. Propranolol and dextromethorphan treated groups expressed lower time in the closed arms vs Placebo (p=0.0089, respectively p=0.0111). In addition, the time spent in the open arms was higher in propranolol group vs placebo group (p=0.0215).
Conclusions: Considering obtained data, there was a decrease of symptoms in the sympathetic nervous system and the psychological stress disappeared in mice applying a treatment of 20 mg/kg bw propranolol. Our findings indicated that dextromethorphan partially mediated the anxiolytic-like activity. However, the combination of these two drugs did not express anxiolytic effects.

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Relationship between obesity and psychosocial risk factors in hypertensive patients

Enikő Nemes-Nagy, Zoltán Preg, Kinga-Ilona Nyulas, Tünde Pál, Sándor Pál, Mariana Cornelia Tilinca, Márta Germán-Salló

George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2021-0030

Introduction: Unhealthy lifestyle habits, including sedentary behaviour and improper diet are major risk factors for obesity. Overweight is very frequent in hypertensive and type 2 diabetic patients. Psychosocial factors are associated with multiple health behaviors related to overweight/obesity. The aim of the study was to evaluate the relationship between obesity and psychosocial risk factors in hypertensive patients having different levels of education.
Material and methods: 623 hypertensive patients, admitted to the Cardiovascular Rehabilitation Clinic in Tîrgu Mureș were evaluated by weight, height, waist circumference, laboratory analyses and psychosocial risk based on a validated questionnaire on nine topics. Non-paired Student t test was used for statistical evaluation of the obtained data.
Results: Obesity or overweight affected 86.9% of the studied hypertensive patients. Obesity was more frequent in subjects having type 2 diabetes as comorbidity. Mean BMI was significantly higher in the lower education group (p=0.007) compared to those with higher level of education. Average triglyceride and uric acid levels were significantly higher in obese subjects compared to those having lower BMI (p<0.0001). Patients living alone had significantly lower mean BMI (p=0.006) and waist circumference values (p=0.001) compared to those living with their spouse.
Conclusions: Weight excess in very frequent in the studied hypertensive patients, especially in those with type 2 diabetes as comorbidity and having lower educational level. Hypertriglyceridemia and hyperuricemia occurred more frequently in obese subjects compared to non-obese ones. Overweight is less frequent in patients living alone.

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The antibacterial potential of biosynthesized silver nanoparticles using beech bark and spruce bark extracts

Anca Delia Mare1, Adrian Man1, Felicia Toma1, Bianca Tudor1, Lavinia Berța2, Corneliu Tanase3, Cristina Nicoleta Ciurea1

1. Department of Microbiology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Department of General and Inorganic Chemistry, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
3. Department of Pharmaceutical Botany, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2021-0043

Introduction: Lately, nanotechnology focuses on the green synthesis of AgNPs, using different plant materials, as this method is accessible, cost-efficient, and ecological. The study aimed to investigate the antibacterial potential of AgNPs synthesized using beech/spruce bark extracts (BBE/SBE) and silver salts (acetate/nitrate).
Method: The growth rates of Staphylococcus aureus ATCC 25923 and Escherichia coli ATCC 25922 were evaluated in the presence of the AgNPs solutions. The checkerboard method was performed to evaluate if these solutions exert synergistic activity with gentamicin.
Results: For E. coli, synergistic effects were observed for the combination of gentamicin 0.25mg/L with AgNP BBE Nit (0.145mg/mL) and with AgNP SBE Ac (0,09mg/mL). For S. aureus, no synergistic effects were observed. Overall, the AgNP BBEs solutions combined with gentamicin presented lowest values of fractional inhibitory concentration than the ones registered for the combination of AgNP SBEs with gentamicin, for both bacterial strains. The growth rate of S. aureus was inhibited by all the tested AgNPs at the measured time points. For E. coli, after 24 hours of incubation, the growth rate was inhibited only in the presence of AgNP SBE Ac. After 6 hours of incubation, the growth rate of E. coli was almost stationary in the presence of AgNP BBE Nit.
Conclusions: The biosynthesis of AgNPs is a valuable choice for obtaining substances with antibacterial potential.

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E-cigarette and alternative tobacco products consumption among adolescents in Chisinau, Republic of Moldova – A repeated cross-sectional study

Aculina Topada1, Valentin Nădășan1, Monica Tarcea2, Zoltán Ábrám1

1. Department of Hygiene, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Targu Mures, Romania
2. Department of Community Nutrition and Food safety, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Targu Mures, Romania

DOI: 10.2478/amma-2021-0039

Objective: The main objective of the study was to evaluate e-cigarette and alternative tobacco product use in ninth-grade students from Chisinau.
Methods: The repeated cross-sectional study collected data using a questionnaire administered in 2015 and 2018 among ninth-grade students in Chisinau, Republic of Moldova. Absolute and relative frequencies of electronic cigarettes and alternative tobacco products ever use were calculated and 2015 data were compared with those collected in 2018.
Results: The percentage of participants ever using electronic cigarettes in 2015 and 2018 respectively was 42.9% and 59.5% (p=0.001), ever using cigars was 14.9% and 15.9% (p=0.684), ever using pipes was 3.3% and 4.9% (p=0.205), ever using hookah was 17.4% and 21.7% (p=0.086), ever using chewing tobacco was 11.6% and 3.9% (p=0.039), ever using snus was 4.1% and 6.2% (p=0.135), and ever using snuff was 0.5% and 1.1% respectively (p=0.518). Exposure of participants to messages promoting electronic cigarettes was 31.0% in 2015 and 65.8% in 2018 (p<0.0001). Consumption of electronic cigarettes was significantly associated with sex (boys 62.8% vs. girls 43.6%), school performance (low grades 61.5% vs. high grades 50.0%), exposure to pro e-cigarette messages (exposed 61.4% vs. not exposed 44.0%), perceived e-cigarettes harmfulness (less harmful 66.9% vs. more harmful 39.7%), and use of conventional cigarettes (ever tried 79.8% vs. never tried 24.6%).
Conclusions: The study showed an important, statistically significant increase in the consumption of electronic cigarettes among ninth-grade students in Chisinau city, from 2015 to 2018 and an increased exposure to electronic cigarette advertising.

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Mediation of Candida species growth and virulence by the proinflammatory cytokine IL-6

Cristina Nicoleta Ciurea1,2, Irina-Bianca Kosovski1,3, Felicia Toma1, Mihai Mareș4, Bianca Tudor1, Adrian Man1

1. Department of Microbiology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Doctoral School, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
3. Department of Pathophysiology, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
4. Laboratory of Antimicrobial Chemotherapy, Ion Ionescu de la Brad University of Life Sciences of Iași, Romania

DOI: 10.2478/amma-2021-0036

Interleukin-6 (IL-6) is a cytokine with pleiotropic effects that might also influence the virulence traits of some microorganisms, but its direct influence over Candida spp. is currently unknown. The objective of the study is to determine the influence of IL-6 (250 pg/ml) on the growth rate and biofilm formation of C. albicans, C. parapsilosis, C. krusei, C. auris, and C. guilliermondii, as well as to analyze the influence of this citokine on the expression of three virulence genes (ALS3, HSP70, SAP2), respectively on the germ tube formation ability of C. albicans. The influence of IL-6 on growth rate was assessed by incubating the fungal cells in presence of IL-6 for 48 hours and assessing the optical density of the samples at five timepoints. The biofilm production in presence of IL-6 was studied in microtiter plates, using crystal-violet assay, the intensity of biofilms being evaluated by spectrophotometry. The expression of ALS3, HSP70, and SAP2 in C. albicans was studied by RT-PCR, reported to ACT1 housekeeping gene. The germ-tube test was performed to assess the influence of IL-6 on the filamentation rate of C. albicans. All test results were normalized against control, without added IL-6. The results showed that IL-6 influences the growth rate of C. albicans, C. parapsilosis, C. krusei, C. auris, and C. guilliermondii in a time-dependent way. Also, IL-6 inhibited the formation of biofilms for C. albicans and C. guilliermondii. In C. albicans cells, IL-6 induced upregulation of ALS3 and HSP70, while it down-regulated the SAP2 gene. IL-6 did not influence the germ-tube formation in C. albicans. In conclusion, IL-6 might exert, in vitro, direct effects on the virulence traits of Candida spp., and its influence is dependent on the exposure time. Non-albicans Candida species presented particular responses to IL-6.

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Formulation and evaluation of controlled release ocusert of gatifloxacin and prednisolone

Navneet Nagpal1, Sukhmanpreet Singh1, Guraasdeep Kaur1, Parminderjit Kaur1, Ravi Kumar Dhawan2, Mandeep Singh Chhina3, Manisha Arora3

1. Department of Pharmaceutics, Khalsa College of Pharmacy, Amritsar, India
2. Department of Pharmacology, Khalsa College of Pharmacy, Amritsar, India
3. Department of Pharmaceutical Chemistry, Khalsa College of Pharmacy, Amritsar, India

DOI: 10.2478/amma-2021-0032

Objective: Ocuserts are sterile, solid, or semisolid dosage forms prepared to attain increased contact time between the drug and the conjunctival tissue to keep up a constant release of drug when placed in the lower cul-de-sac or conjunctival sac of the eye. The aim of formulating this delivery system was to treat both inflammatory and infectious conditions of the eye with increased ocular residence time by releasing drugs at a slow and constant rate.
Method: Gatifloxacin, and prednisolone ocuserts were prepared by solvent casting method, and evaluated for physical appearance, uniformity of weight, thickness, folding endurance, drug content, surface pH, in-vitro, and ex-vivo release profile.
Results: All formulated inserts exhibited positive results in terms of their evaluation parameters. Ocuserts were sterile, with no turbidity in selected media during the study, and they were stable throughout six months.
Conclusion: Results suggested that prepared optimized ocusert formulation would be a suitable alternative to eye drops for treating conjunctivitis and other bacterial infections.

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Online pharmacy: customer profiling

Marius Călin Cherecheș1, Cristian Olimpiu Popa2

1. Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
2. Faculty of European Studies, Babeș-Bolyai University, Cluj-Napoca, Romania

DOI: 10.2478/amma-2021-0031

Introduction: Nearly three out of four European citizens purchase goods online. The main advantages of using an online pharmacy are lower prices and convenience. In addition, patients appreciate a higher degree of privacy and access to a wider selection of health products. Study shows that the number of online users is on the rise in major countries like the USA, EU member states or India.
Methods: The study is based on data collected in April 2020 at the country level (Romania) from a sample of 789 adults over the age of 18, using CATI. A simple random sampling procedure was applied, with a confidence interval of 3.5% and a confidence level of 95%.
Results: About 17.7% of Romanians have purchased healthcare products through online pharmacies or drugstores, of those 60% are women, between 30 – 64 years old (84 %), have a monthly income of more than 2700 lei (90%), and a university degree (76%). The most common reasons for choosing an online pharmacy are the ability to compare prices, shop quickly, and have prompt access to items and information, together with a wider range of products.
Conclusions: Respondents’ motivation to use online pharmacies appears to be more related to the benefits of the online media, rather than to some unmet needs in brick-and-mortar pharmacies. Search capabilities, access to more information, price comparison, as well as a larger range of products and availability 24/7 are some reasons why patients utilise online pharmacies to purchase medicines.

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Breastfeeding and diversification attitudes among Romanian mothers

Anastasia Simion1, Maria Simion2, Geanina Moldovan3

1. County Emergency Clinical Hospital Targu Mures, Romania
2. George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
3. Department of Community Nutrition and Food Safety, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania

DOI: 10.2478/amma-2021-0029

Introduction: Recommended by the World Health Organization as the optimal way of infant feeding, maternal breast milk represents the best nourishment for the newborn baby during its first six months. The purpose of this study was to evaluate some of the Romanian mothers’ characteristics that can influence their attitude towards breastfeeding and food diversification.
Methods: A questionnaire about 32 questions, including demographics items and breastfeeding attitudes, was sent online (socializing platforms) in 2020 to mothers from all Romania districts. Our sample included at the end 1768 subjects, who fully completed the questionnaire. Statistical analysis was carried out using the GraphPad statistical software.
Results: The prevalence of breastfeeding for more than six months was only 32.18% in our group, and most of them were educated mothers who lives in urban areas (OR=2.76), were married (OR=1.98), had over 30 years old (OR=1.43) and have more than one child (OR=1.74).
Conclusions: We underline the importance of tackling in our future community interventions some of the socio-demographic characteristics of pregnant women (like groups education, good and accessible information about breastfeeding, young age, first pregnancy, or mothers from rural areas as well) in developing good habits of breastfeeding or complementary feeding, in order to improve their children health status and proper development.

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