Back ground:Maternal nutritional status influences the developmental environment of the fetus which consequently affects the birth weight of the newborn. However, the association between maternal nutritional factors and birth weight is complex and is not well characterized in Ethiopia.Objective:To assess the effect of maternal anthropometry and biochemical profile on birth weight of babies at Butajira Referral Hospital, Butajira, Ethiopia.Methods and materials:Laboratory-based cross-sectional study was conducted among 337 pregnant women at the hospital. Socio-demographic and obstetric characteristics were collected using pre-tested questionnaires. Blood sample was collected from each pregnant women for determination of total serum protein, total serum cholesterol and hemoglobin level. However, maternal dietary habits were not assessed in this study.Results:A total of 337 pregnant women were involved in the study. The mean (standard deviation) birth weight of the newborns was 3.14 ± 0.46 kg. After adjusting for different maternal factors, parity (p = 0.013), hemoglobin level (p = 0.046), pre-pregnancy body mass index (p < 0.001) and weight gain during pregnancy (p < 0.001) were positively associated with birth weight of the newborns, while the associations with total protein (p = 0.822) and total cholesterol (p = 0.423) were not significant.Conclusion:This study has shown that nutritional status of pregnant women as indicated by maternal anthropometry and hemoglobin level was associated with birth weight of the baby. Therefore, nutritional status of the pregnant women should be improved to reduce the risk of low birth weight.

BackgroundThere is a worldwide upscale in mass drug administration (MDA) programs to control the morbidity caused by soil-transmitted helminths (STHs): Ascaris lumbricoides, Trichuris trichiura and hookworm. Although anthelminthic drugs which are used for MDA are supplied by two pharmaceutical companies through donation, there is a wide range of brands available on local markets for which the efficacy against STHs and quality remain poorly explored. In the present study, we evaluated the drug efficacy and quality of two albendazole brands (Bendex and Ovis) available on the local market in Ethiopia.Methodology/Principal FindingsA randomized clinical trial was conducted according to the World Health Organization (WHO) guidelines to assess drug efficacy, by means of egg reduction rate (ERR), of Bendex and Ovis against STH infections in school children in Jimma, Ethiopia. In addition, the chemical and physicochemical quality of the drugs was assessed according to the United States and European Pharmacopoeia, encompassing mass uniformity of the tablets, amount of active compound and dissolution profile. Both drugs were highly efficacious against A. lumbricoides (>97%), but showed poor efficacy against T. trichiura (~20%). For hookworms, Ovis was significantly (p < 0.05) more efficacious compared to Bendex (98.1% vs. 88.7%). Assessment of the physicochemical quality of the drugs revealed a significant difference in dissolution profile, with Bendex having a slower dissolution than Ovis.Conclusion/SignificanceThe study revealed that differences in efficacy between the two brands of albendazole (ABZ) tablets against hookworm are linked to the differences in the in-vitro drug release profile. Differences in uptake and metabolism of this benzimidazole drug among different helminth species may explain that this efficacy difference was only observed in hookworms and not in the two other species. The results of the present study underscore the importance of assessing the chemical and physicochemical quality of drugs before conducting efficacy assessment in any clinical trials to ensure appropriate therapeutic efficacy and to exclude poor drug quality as a factor of reduced drug efficacy other than anthelminthic resistance. Overall, this paper demonstrates that “all medicines are not created equal”.

Background Malaria caused by Plasmodium vivax and Plasmodium falciparum is among the major public health problems in most endemic areas of the world. Artemisinin-based combination therapy (ACT) has been recommended as a first-line treatment for uncomplicated Plasmodium falciparum malaria almost in all endemic regions. Since ineffectively regulated medicines in resource limited settings could favour infiltration of poor quality anti-malarial medicines into pharmaceutical supply chain and jeopardize a positive treatment outcome, regular monitoring of the quality of anti-malarial medicines is critical. Thus, the aim of this study was to assess the quality of fixed dose combination (FDC) artemether (ART)/lumefantrine (LUM) tablets available in Jimma zone, Ethiopia. Methods This study was conducted in Jimma zone, Ethiopia. A total of 74 samples of FDC ART/LUM (20 mg ART/120 mg LUM) tablets were collected from 27 public facilities. All samples were subjected to visual inspection and the relevant information was recorded. The samples were transported to Jimma University Laboratory of Drug Quality (JuLaDQ) and stored at ambient temperature (20 °C to 25 °C) until analysis. The Pharmacopoeial conform/non-conform methods and the risk-based Derringer’s desirability function approach were employed to assess the pharmaceutical quality of the investigated products. Results The visual inspection results revealed that there were no signs of falsified in the investigated products. Identification test results of samples indicated that all samples contained the stated active pharmaceutical ingredients (APIs). The results of uniformity of mass indicated that all samples complied with International Pharmacopoeial specification limits. The assay results, expressed as percent label claim (%lc) of ART (89.8 to 108.8%, mean ± SD = 99.1 ± 3.9%) and LUM (90.0 to 111.9%, mean ± SD = 98.2 ± 3.8%) revealed that, all samples complied with International Pharmacopoeia acceptance specification limits (i.e. 90–110%lc), except one generic product (IPCA Laboratories Ltd., India) which contains excessive LUM (111.9 ± 1.7%lc). The risk priority number (RPN) results revealed that assay (RPN = 392) is relatively the most critical quality attribute followed by identity (RPN = 280) and mass uniformity (40). Quality evaluation based on psycho-physical Harrington’s scale revealed that more than 96% of samples were within the acceptable ranges (D ≥ 0.7–1.0). Conclusions Both Pharmacopoeial and risk-based desirability function approaches to quality evaluation applied to the investigated products revealed that above 96% FDC ART/LUM tablets circulating in public settings of Jimma zone are of good quality. Electronic supplementary material The online version of this article (10.1186/s12936-019-2872-1) contains supplementary material, which is available to authorized users.

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Background: Dissolution is the critical quality control parameter and used to predict an in vivo oral bioavailability, and it is used to support bio-waiver. Aim: To evaluate and compare the dissolution profile of eight brands of metformin HCL 500 mg tablets available in Jimma town, Southwest Ethiopia. Methods: The study was conducted in Jimma town, Ethiopia. Eight (seven brands and one comparator) metformin HCL 500 mg tablets were included. The dissolution study was conducted as per United States Pharmacopeia, and the dissolution profile was compared by one-way ANOVA, model-dependent and model-independent approaches. Results: All of the included tablet brands complied with single-point dissolution study specification. Statistical comparisons of the dissolution profile by one-way ANOVA revealed that all brands had similar dissolution profiles (p=0.89). All of the brands had a similarity factor (f 2 ) >50% and the difference factor (f 1 ) <15. The entire brands followed the Weibull curve approach (the highest coefficient of determination and lowest Akaike Information Criteria) for the release of an active pharmaceutical ingredient. Conclusion:All of the brands complied with single point dissolution study and all of them could be used interchangeably with the innovator drug. All brands followed the Weibull method for the release of the drug substance.