ORIGINAL RESEARCH ARTICLE | April 3, 2025
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Formulations of Losartan Potassium Tablets USP 100 mg under Fasting Conditions
Gunasakaran Sambandan, Nisha Rajendran, Vivek Partheeban, Ashok Partheeban
Page no 125-130 |
https://doi.org/10.36348/sjbr.2025.v10i04.001
This study was designed to evaluate the bioequivalence of Losartan Potassium Tablets USP 100 mg, developed by Caplin Point Laboratories Ltd., India, compared with COZAAR® (Losartan Potassium Tablets USP 100 mg) manufactured by Merck Sharp & Dohme LLC, Chile. Conducted under fasting conditions, this open-label, randomized, two-treatment, three-sequence, three-period, single-dose, crossover, semi-replicate study aimed to assess pharmacokinetic parameters and the safety profile of both formulations in healthy adult human subjects. A total of 39 participants were enrolled, with 30 completing all study phases. Blood samples were collected at 28 predefined time points in each study period and analyzed for plasma concentrations of Losartan and its active metabolite, carboxylic acid, using a validated bioanalytical method. Key pharmacokinetic metrics such as Cmax, AUC0-t, and AUC0-∞ were determined, and the log-transformed data were subjected to statistical analysis. Results demonstrated that the 90% confidence intervals of the test/reference ratio for Cmax (82.57%–117.03%), AUC0-t (98.11%–107.46%), and AUC0-∞ (98.09%–107.37%) were all within the predefined bioequivalence acceptance range of 80.00%–125.00%. These findings established bioequivalence between the test and reference formulations. Safety evaluations revealed five adverse events among four subjects, all of which were mild to moderate and resolved completely without sequelae. In conclusion, the study confirms that Losartan Potassium Tablets USP 100 mg by Caplin Point Laboratories Ltd. is bioequivalent to COZAAR® and is well-tolerated under fasting conditions. These results support the potential for the test product to serve as a cost-effective and accessible therapeutic alternative for managing hypertension.
ORIGINAL RESEARCH ARTICLE | April 9, 2025
Exploring the Antibacterial Activity of Zinc Oxide Nanoparticles against Some Selected Gram-Positive and Gram-Negative Bacteria
Abiola Olanike Adesina
Page no 131-139 |
https://doi.org/10.36348/sjbr.2025.v10i04.002
Increase in microbial resistance of commonly used antibiotics is a major health concern globally this has necessitated researchers to focus on cheaper alternative materials which could perform the role of antibiotics. This study aimed at investigating the synthesis of zinc oxide nanoparticles (ZnO Nps) and exploring the synthesized nanoparticles as sources of antimicrobials. The antimicrobial activity of the synthesized zinc oxide nanoparticles was tested against ten different bacteria namely; Enterobacter agglumerans, Corynebacterium bovis, Pseudomonas aeruginosa, Acinetobacter baumannii, Escherichia coli, Micrococcus luteus, Klebsiella pneumoniae, Bacillus subtilis, Staphylococcus aureus, and Bacillus cereus. The results from this study revealed that four out of the test organisms (S. aureus, B. cereus, E. coli and Bacillus subtilis) were susceptible to the ZnO nanoparticles. The diameter of the zones of inhibition (ZOI) ranging from 14.50 – 25.50 mm. The synthesized nanoparticles showed the highest activity with S. aureus (ZOI = 25.50 mm, followed by B. cereus (22.00 mm), E. coli and B. subtilis (14.50 mm). The minimum inhibitory concentration (MIC) results showed that ZnO NPs was most effective against S. aureus and B. cereus at 25% concentration while minimum bactericidal concentration (MBC) was at 50%. These findings revealed that zinc oxide nanoparticles have great potentials for inhibiting clinical isolates; thus, their use as an alternative means for new drug discovery should be encouraged.