Bioequivalence evaluation of two capsule formulations of amoxicillin in healthy adult male bangladeshi volunteers: A single-dose, randomized, open-label, two-period crossover study

AbstractBackground: Amoxicillin, a semisynthetic penicillin antibiotic, is widely prescribed in Bangladesh due to its extended spectrum and its rapid and extensive oral absorption with good tolerability. Although a number of generic oral formulations of amoxicillin are available in Bangladesh, a study of the bioequivalence and pharmacokinetic properties of these formulations has not yet been conducted in a Bangladeshi population.Objective: The aim of this study was to assess the pharmacokinetic properties and bioequivalence of 2 formulations of amoxicillin 500-mg capsules (test, SK-mox®; reference, Amoxil-Bencard®) using serum data.Methods: This single-dose, randomized, open-label, 2-period crossover study was conducted in healthy male subjects in compliance with the Declaration of Helsinki and International Conference on Harmonisation guidelines. Subjects were assigned to receive the test or the reference drug as a single-dose, 500-mg capsule under fasting conditions after a 1-week washout period. After oral administration, blood samples were collected and analyzed for amoxicillin concentration using a validated high-performance liquid chromatography method. The pharmacokinetic parameters were determined using a noncompartmental method. The formulations were considered bioequivalent if the natural log-transformed ratios of pharmacokinetic parameters were within the predetermined equivalence range of 80% to 125%, according to the US Food and Drug Administration (FDA) requirement.Results: Twenty-four healthy adult male Bangladeshi volunteers (mean [SD] age, 26.92 [3.37] years; age range, 23–34 years; mean [SD] body mass index, 23.O9 [1.58] kg/m2) participated in the study. Using serum data, the values obtained for the test and reference formulations, respectively, were as follows: Cmax, 9.85 (2.73) and 10.63 (2.12) μg/mL; Tmax, 1.29 (0.58) and 1.33 (0.49) hours; and AUC0–12, 27.09 (7.62) and 28.56 (6.30) μg/mL · h−1. No period, sequence, or formulation effects were observed; however, significant variation was found among subjects with regard to AUC0–12 (P < 0.001), AUC0−∞ (P = 0.002), area under the moment curve (AUMC) from 0 to 12 hours (P < 0.001), and AUMC0−∞ (P = 0.017). All CIs for the parameters measured were within the FDA-accepted limits of 80% to 125%.Conclusion: The present study suggests that the test 500-mg amoxicillin capsule was bioequivalent to the reference 500-mg capsule according to the FDA regulatory definition, in this population of healthy adult male Bangladeshi volunteers

Does Integrated Healthcare System Reduce the Cost of Quality of Care for Older People? A scoping review

This study provides a summary of published reviews of academic literature on the cost-effectiveness and quality outcomes of integrated healthcare approaches for the older people of Australia. The published English-language literature between January 2001 and July 2017 was retrieved from search results in eight highly resourceful journal databases using the specific terms. The majority studies reported limited information about the cost intervention and quality of outcomes. The benefits of integrated healthcare included patients’ satisfaction, reduction of costs and increasing quality of care. However, the evidence of reduction of cost is varying with the different settings. The home and community-based healthcare for older people have garnered much attention in the past decades in Australia and many researches have been done on it. The majority of the studies focused on defined problems of healthcare service and outcomes, but did not incorporate the priorities of cost-effectiveness or quality of care. Practitioners are interested to understand how the integrated health care approach is achieved and to examine the reduction of cost and quality of outcomes.&nbsp

Regional variation in chronic kidney disease and associated factors in hypertensive individuals in rural South Asia: Findings from control of blood pressure and risk attenuation-Bangladesh, Pakistan and Sri Lanka

Background: We aimed to determine the prevalence of chronic kidney disease (CKD) and its cross-country variation among hypertensive individuals in rural Bangladesh, Pakistan and Sri Lanka. We also explored the factors associated with CKD in these populations.Method: We studied baseline data from the Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS) trial, an ongoing cluster randomized controlled trial on 2643 hypertensive adults ≥40 years of age from 30 randomly selected rural clusters, 10 in each of the three countries. CKD was defined as an estimated glomerular filtration rate (eGFR) /min/1.73 m2 or a urine albumin:creatinine ratio (UACR) ≥30 mg/g. Determinants for CKD were assessed using logistic regression analysis.Results: The overall prevalence of CKD was 38.1% (95% confidence interval 36.2-40.1%): 21.5% with eGFR \u3c60 mL/min/1.73 m2 and 24.4% with UACR ≥30 mg/g. CKD prevalence varied across the three countries (58.3% in Sri Lanka, 36.4% Bangladesh and 16.9% Pakistan; P \u3c0.001). The factors independently associated with higher odds of CKD were older age, being unmarried, higher 24-h urinary sodium excretion, presence of diabetes, elevated systolic blood pressure, diuretic use and living in Bangladesh or Sri Lanka (versus Pakistan).Conclusions: The prevalence of CKD is alarmingly high in community-dwelling hypertensive adults, with significant cross-country variation in South Asia. Our findings underscore the urgency for further research into the etiology of CKD and address associated factors in targeted public health strategies with hypertension care outreach services in rural South Asia

Impacts of Plastic Filming on Growth Environment, Yield Parameters and Quality Attributes of Lettuce

The condition of soil and microclimate are prerequisite for proper growth and development of a plant. The environment may be mediated by artificial filming with different colored polyethylene. The mechanism of lettuce growing under colored plastic film remains largely unknown. Thus, to investigate the impact of different plastic film on the growth environment, yield parameters and phytochemical properties of lettuce, the present study was performed. Five different colored polyethylene films viz. black, white, blue, olive and silver were used as a treatment factor, in filed condition. The results demonstrated that the soil pH, temperature and overall performance of lettuce, as well as the phytochemical composition, varied within the use of different films. The maximum soil pH and temperature were found under black filming plots. Additionally, the black colored plastic film exhibited the best values for most of the yield parameters studied over other plastic films, whereas the field with non-plastic film condition showed the worst data in the experiment. Phytochemical concentrations and nutritive value of lettuce were also significantly affected by the colored plastic treatments. Furthermore, the chlorophyll, anthocyanin, phenols and carotenoids contents were increased in plants grown in soil covered with black polyethylene. Vitamin C content was of 2.5 fold higher in the plants grown in the black film compared to control conditions. The application of plastic film led to elevated concentrations of macro and micronutrients in lettuce because of the direct effect of modified radiation under the plastic film. Taken together, it can be concluded that plastic filming could be used to enhance the yield and nutritional status of lettuce in natural plant production facilities

Bangladesh arsenic mitigation programs: lessons from the past

Ensuring access to safe drinking water by 2015 is a global commitment by the Millennium Development Goals (MDGs). In Bangladesh, significant achievements in providing safe water were made earlier by nationwide tubewell-installation programme. This achievement was overshadowed in 1993 by the presence of arsenic in underground water. A total of 6 million tubewells have been tested for arsenic since then, the results of which warranted immediate mitigation. Mitigation measures included tubewell testing and replacing; usage of deeper wells; surface water preservation and treatment; use of sanitary dug wells, river sand and pond sand filters; rainwater collection and storage; household-scale and large-scale arsenic filtrations; and rural pipeline water supply installation. Shallow tubewell installation was discouraged. Efforts have been made to increase people's awareness. This paper describes the lessons learned about mitigation efforts by the authors from experience of arsenic-related work. In spite of national mitigation plans and efforts, a few challenges still persist: inadequate coordination between stakeholders, differences in inter-sectoral attitudes, inadequate research to identify region-specific, suitable safe water options, poor quality of works by various implementing agencies, and inadequate dissemination of the knowledge and experiences to the people by those organizations. Issues such as long-time adaptation using ground water, poor surface water quality including bad smell and turbidity, and refusal to using neighbor's water have delayed mitigation measures so far. Region-specific mitigation water supply policy led by the health sector could be adopted with multisectoral involvement and responsibility. Large-scale piped water supply could be arranged through Public Private Partnerships (PPP) in new national approach

Crop Yield and Reduction of Soil Loss with Selected Hedge Species under Different Hill Slopes in Chittagong Hill Tract

This research was concluded at Chittagong Hill Tracts in Bangladesh to identify the effects of different hedge species and assess alley width in controlling soil erosion and crop yield. Hedgerow or alley cropping cultivation is very helpful in reducing soil erosion in the hilly area. In order to perform cataloguing the hedges and their alley, four hedge species such as Indigofera, Bogamedula, Pineapple and Napier were used. Three different slopes viz., gentle slope, moderate slope and steeps slope, two different crops like yard long bean and okra were used in this experiment. The experiment lay out was in Split Plot Design with three replications. Soil erosion was measured through spike lay out method. Wider alley width gives a better performance of yield. Grass species (Napier) responses better than tree/shrub species (Bogamedula and Indegofera) on crops yield. Performance of pineapple among all other hedge species on crop yield and soil loss reducing capacity was recorded the best on all slope gradients and alley width. More yields were gained from the managed plots by hedge, though the number of total plant was comparatively less in those plots than the controlled one. Slope gradients have got the most important role on crops yield and soil erosion factor. The highest yields and the lowest soil loss were recorded in gentle slope in comparison with moderate and steep slope respectively. Crops yield were significantly reduced with the increase of slope gradients

Pattern of Adverse Drug Reactions Due to Cancer Chemotherapy in Tertiary Care Teaching Hospital in Bangladesh

ABSTRACT: The objective of the present study was to evaluate the pattern of adverse drug reactions (ADRs) occurring in cancer patients treated with chemotherapy in tertiary care hospitals in Bangladesh. A prospective hospital based study over a period of six month was carried out in the Department of oncology, Bangabandhu Sheikh Mujib Medical University and Dhaka Medical College Hospital. The data were subjected to descriptive analysis. A total of 50 patients having ADRs due to cancer chemotherapy were randomly selected. Adverse drug reactions were mostly occurred in the age group between 41-50 years (26%). Considering socio-economic status of cancer patients married persons (82%) have significantly higher risk than unmarried (18%). Prevalence of breast cancer (20%), cervical cancer (14%) and leukemia (16%) were higher and they were treated mostly by adjuvant chemotherapy (46%) and secondly by chemotherapy (38%) alone. In most cases ADRs were developed in patients receiving alkylating agents (40%) and antimetabolites (40%) as anticancer therapy. The five certain ADRs observed in the current study were nausea, stomatitis, alopecia, myelosuppression and increased ESR level in both male and female patients. Moreover, hematological system was affected severely by alkylating agents and antimetabolites. Similar studies covering more patients from different regions are needed to validate our findings