Department of Pharmacology, Clinical and Social Pharmacy

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    Quality Evaluation of Different Brands of Metformin Hydrochloride 500 Mg and 850 Mg Tablets Available in Mekelle City
    (Mekelle University, 2024-12-28) Afewerki Tesfay
    Introduction: Metformin is the most commonly prescribed drug. The accessibility of substandard and falsified metformin products in the market lead to treatment failure, increased mortality, and morbidity. Ethiopia has a low port control and a weak regulatory system. Additionally, in Tigray, several brands of metformin tablets have been released into the market for the past three years without proper regulatory systems. To address this concern, this study was conducted. Objective: This study aims to assess and compare the quality of different brands of metformin 500 mg and 850 mg tablets available in Mekelle City, Tigray, Ethiopia. Method: Quality parameter tests such as physical characteristics, friability, dissolution, disintegration, weight variation, assay, and hardness tests were conducted as per British Pharmacopeia (BP), World Health Organization (WHO), and non-official standards. Data were analyzed using Origin Pro 2024 and one-way analysis of variance (ANOVA). To compare the dissolution profile of the tested product against the innovator, similarity factor (f2), and difference factor (f1) was used. Result: Except for one brand, they all had online EFDA registration numbers. For metformin 500 mg brands: Weight variation ranges from -3.96 % to 2.22 %, assay value ranges from 95.2% to 102.1%, and dissolution value ranges from 90.4 % to 99.7 % at 45 minutes. For metformin 850 mg brands: Weight variation ranges from -2.1 % to 2.6 %, assay value ranges from 97.9% to 103.7%, and dissolution value ranges from 97.9 % to 101.6. % at 45 minutes. Conclusion: Except for the hardness test, all the tested brands of metformin hydrochloride 500 mg and 850 mg tablets met the official BP and WHO specifications. This study could help to patients, EFDA, independent research groups, and other concerned bodies to get updated information on the quality status of metformin 500 mg and 850 mg tablets.
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    EVALUATION OF ANTIDIARRHEAL ACTIVITY OF 80% METHANOLIC STEM BARK EXTRACT OF TERMINALIA BROWNII FRESEN (COMBRETACEAE)
    (Mekelle University, 2025-04-25) Selamawit Tesfamariam
    Terminalia brownii is a medicinal plant traditionally used in Africa to manage diarrhea. Despite its ethnomedicinal significance, the safety and efficacy of its extracts remain underexplored in preclinical studies. This study aimed to evaluate the antidiarrheal properties and acute toxicity of an 80% methanolic stem bark extract of Termination brownii to bridge this scientific gap. The antidiarrheal activity of the 80% methanolic extract of Terminalia brownii was assessed using three models: the castor oil-induced diarrheal model, charcoal meal test, and enteropooling test in mice. Negative controls were treated with distilled water (10 mL/kg, oral), Test groups received the extract orally at doses of 100, 200, and 400 mg/kg. while positive controls received loperamide hydrochloride (3 mg/kg, oral). The extract delayed the onset of diarrhea and reduced the number and weight of wet feces, as well as total fecal weight, in a dose-dependent manner in the castor oil-induced diarrhea model. The diarrheal inhibition percentages were 28%, 53.42%, and 74.12% at doses of 100 mg/kg, 200 mg/kg, and 400 mg/kg, respectively, demonstrating a substantial dose-dependent increase in efficacy.The extract at 200 and 400 mg/kg demonstrated peristaltic indices of 54.5% and 37.3%, respectively, alongside significant inhibition of charcoal transit (39.5% and 58.9%) in the charcoal meal test. In the enteropooling test, the 400 mg/kg dose significantly reduced intestinal content weight and volume to 0.29 g and 0.24 mL, respectively, comparable to the loperamide-treated group (0.28 g and 0.22 mL). The in vivo antidiarrheal index revealed diarrhea inhibition values of 20.87%, 56.06%, and 86.81% for the extract (100, 200, and 400 mg/kg, respectively) and 92.77% for loperamide (3 mg/kg). This study demonstrated that the 80% methanolic stem bark extract of Terminalia brownii has significant antidiarrheal effects, validating its traditional use. The mechanism of action and long-term toxicity remain uncharacterized. Future studies should isolate bioactive compounds, assess chronic toxicity, and conduct clinical trials to confirm human efficacy. They should also focus on elucidating the mechanism of action behind the antidiarrheal effect.
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    Evaluation of Microcrystalline Cellulose isolated from Mango (mangofera indica) kernel as Directly Compressible Pharmaceutical Excipient
    (Mekelle University, 2024-10-28) DERSO TEJU
    Cellulose, obtained predominantly from wood and cotton, stands as the most abundant natural polymer on earth. The consumption of cellulose for various industrial application is continuously increasing worldwide. The extraction of cellulose from agricultural waste addresses critical issues by enhancing efficient resource utilization, minimizing waste, and reducing the environmental impacts associated with deforestation. Therefore, a sustainable enviroment may be established by using the abundant agricultural waste from plant fibers. Mango is one of the main fruit crops produced and exported in Ethiopia. Therefore, this work aimed to prepare and characterize mango kernel microcrystalline cellulose (MK-MCC) and assess it as directly compressible pharmaceutical excipient. Mango kernel cellulose was extracted using NaOH treatments, then cellulose was hydrolyzed by HCl to prepare mango kernel microcrystalline cellulose. The isolated MCC was characterized through scanning electron microscope, Fourier Transform infrared spectroscopy, Laser diffraction, thermogravimetric analysis and x-ray diffraction and compared with Avicel PH 101. The mechanical properties of both plain MK-MCC tablets and model drug (paracetamol) containing MK-MCC tablets were evaluated and compared with standard Avicel PH 101 tablets. Cellulose and MCC yield on the dry weight basis of mango kernel were found to be 36.5% ± 1.57 and 28.64% ±1.66 respectively. Crystallinity index (CrI) of Mango kernel cellulose was 76.5%. Scanning electron microscopy also showed MK-MCC had smooth surface morphology, irregular and rod-shaped fiber strands. The MK-MCC powders exhibited a bimodal, moderate particle size distribution. The physicochemical studies of MK-MCC revealed moisture content 3.47% w/w, ash value (0.07), pH (5.97), water soluble substances (0.14%) and ether soluble substances (0.03%) that were all within the allowable limit of USP 30/NF 25. MK-MCC preparations showed lower crushing and tensile strengths than Avicel PH-101. MK-MCC effectively incorporated 50% paracetamol in a tablet formulation suitable for direct compression. Based on the results of this study mango kernel could be a promising locally available potential source of cellulose and MCC for pharmaceutical applications.