OBJECTIVES:Urinary tract infection (UTI) is a frequent disorder and depends on age and gender. Ineffective empiric treatment of UTI is common when associated with extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae. The aim of the study was to investigate the prevalence of Gram-negative uropathogens of E. coli and K. pneumoniae in different age groups along with the identification of ESBL-producing uropathogens and antimicrobial susceptibility profiles.MATERIALS AND METHODS:A total of 247 uropathogens of E. coli and K. pneumoniae were collected over a period of 1 year (January–December 2015) from various diagnostic centers of Karachi city (Pakistan). Antimicrobial susceptibility analysis was performed by disc diffusion method, and identification of ESBL was performed by double disc synergy test. Categorical data of ESBL and non-ESBL uropathogens were analyzed by Pearson's Chi-square test.RESULTS:The study of 247 patients with community-acquired UTI comprised 72% females and 28% males, illustrating an increased prevalence of UTIs among females. It was also revealed that 90% belonged to the age group of 16–30 years whereas 78% related to the age group of 46–60 years. ESBL was found positive in 33.5% (63/188) of E. coli and 15.25% (9/59) in K. pneumonia, with a significant association i.e., (p =0.007). Amikacin, fosfomycin, imipenem, and tazobactam/piperacillin were found to be the effective treatment options. A significant association was found between ESBL-producing uropathogens against ciprofloxacin, enoxacin, and amoxicillin/clavulanic acid resistance (P < 0.05).CONCLUSIONS:It was concluded that for effective treatment of UTIs, appropriate screening of ESBL and culture sensitivity must be employed instead of empiric treatment.

The aim of present study was to compare the quality of atenolol tablets and examine the possibility of biowaiver study for approval of generic drugs without additional in vivo bioequivalence study. Atenolol, a cardio selective β-blocker, could be clearly classified into BCS Class III and may be evaluated under biowaiver conditions. Due to the importance of atenolol and availability of different generics in a community basis, four products available in Ras Al Khaimah were analyzed. Four brands of atenolol 100 mg tablets have been evaluated using some quality control parameters, such as weight variation, hardness, content assay, disintegration and dissolution test. In vitro dissolution testing can be used in some cases not only to determine the quality of the pharmaceutical products but also to demonstrate bioequivalence to the generic product. Similarity factor (f 2) and Difference Factor (f 1) were used to assess bioequivalency among four products. The FDA recommended dissolution medium for atenolol is 0.1N HCl but it shows a good releasing pattern in water also. The dissolution profiles of Aten-4 and Aten-2 in pH 1.2 is rapid and good, only Aten-3 failed to cross the similarity factor but f 1 is within limit. In pH 4.5 and 6.8 all brands fulfilled biowaiver requirements, except Aten-2 in pH 6.8 that may be due to manufacturing process difference. In the same time Aten-2 has f 1 value 12 that is within the limit. Therefore, generic drugs with differing in vitro dissolution will not necessarily exhibit different in vivo performance. The results suggest that the formulation and/or the manufacturing process affect the dissolution and thus the bioavailability of the drug products. Thus the significance of the observed in-vitro differences must be confirmed by an in-vivo bioequivalence study.

Purpose: To prepare orally disintegrating tablets (ODT) of montelukast sodium using Design-Expert for improved patient compliance. Methods: Central composite design was selected to delineate and optimize the formulations. Concentrations of crospovidone (X1) and sodium bicarbonate (X2) were selected as the variables, and responses were based on friability (Y1) and disintegration time (Y2). Varying amounts of super disintegrating agents and effervescent bases were used with microcrystalline cellulose to prepare montelukast sodium ODT. Results: Carr's index of montelukast sodium was 4.76±0.075, indicating the good compressibility of powder. Whereas the Carr's value for microcrystalline cellulose and mannitol were 30.14±0.021 and 22.41±0.053 respectively. The FTIR spectra indicated that there were no major shifting and loss of functional groups in drug and excipients blends. Formulations were evaluated, check point batch (CPB, F2) was selected using Design-Expert. The friability of CPB tablets was found to be 0.27 ± 0.085;

Objectives:The efforts were made to develop a HPLC analytical method for the simultaneous quantitative estimation of aspirin and clopidogrel and aim to identify and estimate the degradation of the drugs under the various stress conditions recommended by ICH guideline. Materials and Methods: The separation of two drugs were done by using LC-22AD liquid chromatograph having SPD-22A UV-vis detector on C 8 (4.6 x 52 mm) column which was connected with loop 22µl and with HPLC-Dell system. Mobile phase consisted of acetonitrile: buffer in the ratio of 1352:652 v/v. Flow rate was .13 ml/min and detection were done at 222 nm. Proportions of solvents and adjustment of mobile phase was carried out by screening. Results: The chromatographic separation of aspirin was noted at 4.299 minutes with average USP tangent of 813132.246 and clopidogrel was at 2.726 min with average of 886.21397 tangent. A linear correlation was observed between concentration of aspirin and clopidogrel with their dilutions i.e r 2 = 2.9986 and 2.9996 respectively. The outcome of study, with limit of detection 2.258 and 2.278 µg/ml and limit of quantification 2.7 and 2.56 µg/ml, for aspirin and clopidogrel revealed the repeatability, reproducibility and robustness of the method. Stability indicating parameters were tested by ICH guideline. Conclusion: It is concluded that the method is linear, reproducible, robust, rugged and stability-indicating for simultaneous calculation. It can be used as a routine quality control method for combined pharmaceutical dosage form and for its kinetic studies.

The aim of the study was to evaluate the effect of different lubricants on pharmaceutical effectiveness of metronidazole tablets determined by the rate of release of drug from the dosage form. Different lubricants, like magnesium stearate, talc and the combination of both were used to prepare metronidazole tablets by direct compression method. The tablets were tested for quality control parameters such as uniformity of weight, thickness, diameter, contents assay, hardness, friability and disintegration time. Formulations were tested for the releasing pattern of drug from tablets by in-vitro dissolution test. Better results were achieved from formulation having magnesium stearate as lubricant based on compression force value. The content uniformity for all the three formulations was found in the range of 96.71 to 99.61%, while hardness was in the range of 7.39±0.341 to 10.375±0.95 Kg. The formulated tablets were also analyzed for dissolution profile which was more than 85% within 20 minutes. Then it was compared with dissolution profile of marketed products for quality and similarity analysis. Lubricant plays a key role in successful manufacturing of pharmaceutical solid dosage forms. Many failures in pharmaceutical manufacturing operations, directly or indirectly, can be controlled by appropriate screening of lubricants.