Comparative Quality Evaluation of Selected Brands of Cefuroxime Axetil Tablets Marketed in the Greater Accra Region of Ghana.

The ever-growing commercialization of poor-quality and substandard medicines, especially anti-infectives characterized by inadequate postmarket surveillance by stakeholders remains a major global health challenge, particularly in developing countries, where antibiotic drug resistance and its repercussions on human health remain dominant. This research sought to evaluate the pharmaceutical quality of six randomly selected brands of cefuroxime axetil tablets (250 mg) marketed in the Greater Accra region of Ghana. The selected brands were coded and subjected to both compendial and noncompendial tests. Statistical analysis and model-independent parameter (similarity factor, f2) were employed in analyzing the dissolution profiles of all the brands. All brands including the reference brand conformed to the pharmacopeial specifications for both compendial and noncompendial tests, indicating that they were of good quality. However, there were significant variations (p < 0.05) in the disintegration time amongst the various brands. All the brands had ƒ2 values > 50 indicating similarity of their drug release profiles with the innovator. Hence, all the sampled cefuroxime axetil brands can be considered as pharmaceutical equivalents to the innovator drug. These brands can, therefore, be used as a substitute for the innovator drug by physicians to patients in cases of unaffordability or unavailability of the innovator brand.

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials.

Global Pharma Health Fund (GPHF) Minilab™, a semi-quantitative thin-layer chromatography (TLC)-based commercially available test kit, is widely used in drug quality surveillance globally, but its diagnostic accuracy is unclear. We investigated the diagnostic accuracy of Minilab system for antimicrobials, using high-performance liquid chromatography (HPLC) as reference standard. Following the Minilab protocols and the Pharmacopoeia of the People's Republic of China protocols, Minilab-TLC and HPLC were used to test five common antimicrobials (506 batches) for relative concentration of active pharmaceutical ingredients. The prevalence of poor-quality antimicrobials determined, respectively, by Minilab TLC and HPLC was amoxicillin (0% versus 14.9%), azithromycin (0% versus 17.4%), cefuroxime axetil (14.3% versus 0%), levofloxacin (0% versus 3.0%), and metronidazole (0% versus 38.0%). The Minilab TLC had false-positive and false-negative detection rates of 2.6% (13/506) and 15.2% (77/506) accordingly, resulting in the following test characteristics: sensitivity 0%, specificity 97.0%, positive predictive value 0, negative predictive value 0.8, positive likelihood ratio 0, negative likelihood ratio 1.0, diagnostic odds ratio 0, and adjusted diagnostic odds ratio 0.2. This study demonstrates unsatisfying diagnostic accuracy of Minilab system in screening poor-quality antimicrobials of common use. Using Minilab as a stand-alone system for monitoring drug quality should be reconsidered.

Prophylactic antibiotic treatment in severe acute ischemic stroke: the Antimicrobial chemopRrophylaxis for Ischemic STrokE In MaceDonIa-Thrace Study (ARISTEIDIS).

Infections represent a leading cause of mortality in patients with acute ischemic stroke, but it is unclear whether prophylactic antibiotic treatment improves the outcome. We aimed to evaluate the effects of this treatment on infection incidence and short-term mortality. This was a pragmatic, prospective multicenter real-world analysis of previously independent consecutive patients with acute ischemic stroke who were >18 years, and who had at admission National Institutes of Health Stroke Scale (NIHSS) >11. Patients with infection at admission or during the preceding month, with axillary temperature at admission >37 °C, with chronic inflammatory diseases or under treatment with corticosteroids were excluded from the study. Among 110 patients (44.5 % males, 80.2 ± 6.8 years), 31 (28.2 %) received prophylactic antibiotic treatment, mostly cefuroxime (n = 21). Prophylactic antibiotic treatment was administered to 51.4 % of patients who developed infection, and to 16.4 % of patients who did not (p < 0.001). Independent predictors of infection were NIHSS at admission [relative risk (RR) 1.16, 95 % confidence interval (CI) 1.08-1.26, p < 0.001] and prophylactic antibiotic treatment (RR 5.84, 95 % CI 2.03-16.79, p < 0.001). The proportion of patients who received prophylactic antibiotic treatment did not differ between patients who died during hospitalization and those discharged, or between patients who died during hospitalization or during follow-up and those who were alive 3 months after discharge. Prophylactic administration of antibiotics in patients with severe acute ischemic stroke is associated with an increased risk of infection during hospitalization, and does not affect short-term mortality risk.

Cefuroxime, cefamandole, cefoxitin, and cephalothin in vitro susceptibility tests: reassessment of the "class representative" concept, confirmation of disk interpretive criteria, and proposed quality control guidelines.

The relationship of cefuroxime in vitro susceptibility tests to similar cephalosporins (cefamandole, cefoxitin, and cephalothin) was evaluated using 396 recent clinical isolates. The previously published interpretive criteria of greater than or equal to 18 mm (less than or equal to 8.0 micrograms/mL) = susceptible and less than or equal to 14 mm (greater than or equal to 32 micrograms/mL) = resistant for each drug were considered appropriate. The results of all study methods demonstrated cefuroxime to be slightly less active than cefamandole against most species, yet both drugs possessed nearly identical antimicrobial spectra. Cephalothin and cefoxitin were confirmed to have spectra significantly different from cefamandole and from each other, thus requiring separate testing. The application of the "class representative" concept to cefuroxime and cefamandole seems justified. Use of a 30-micrograms cefuroxime disk yielded the best predictive results and minimized the number of false-susceptible (very major) interpretive errors. Quality control guidelines are presented in a tentative form for cefuroxime, and modifications in the cephalothin and cefamandole zone limits are suggested.