Quality equivalence and in-vitro antibiotic activity test of different brands of amoxicillin/clavulanic acid tablets in Mwanza, Tanzania: A cross sectional study.

Background: Each film coated tablet of amoxicillin/clavulanic acid contains 500 mg of amoxicillin as an active pharmaceutical ingredient and 125 mg of clavulanic acid. Different brands have the same active ingredients but different excipients, which may cause differences in efficacy. With the emergence of generic antibiotics post-patent expiration, the antibiotic activity of generics is in question in comparison to the innovator. This study aims at determining the pharmaceutical quality and in-vitro antimicrobial activity of different brands of amoxicillin/clavulanate. Method: ology: The study was a cross-sectional laboratory-based experimental study conducted at the TMDA (Tanzania Medicines and Medical Devices Authority) Lake Zone laboratory and the CUHAS Microbiology Laboratory from in May 2021. The study samples were four brands of amoxicillin/clavulanate and sixty archived isolates, thirty of which were E. coli and the remaining thirty K. pneumoniae. Determination of minimum inhibitory concentrations, assay and dissolution test results were used to make conclusions for the study. Results: All tablets samples complied with the British pharmacopeia (BP) specifications, however sixty archived isolates which were tested in this study showed resistance towards the standard AMC disc (68 %). The innovator brand (AC1) showed significant mean difference from 2 out of 3 generics (p-values <0.05) while the first generic brand (AC2) showed significant superiority among the generics. Conclusion: Thus, the four samples that were used all complied with the specifications according to BP on dissolution and assay tests but there was an overall resistance towards amoxicillin/clavulanate, and this was moreover seen by generic brands in comparison to the innovator which proved to be of superior activity.

Efficacy of disinfectants on control and clinical bacteria strains at a zonal referral hospital in Mwanza, Tanzania: a cross sectional hospital-based study.

Contaminated-hospital surfaces are an important source of pathogenic bacteria causing health-care associated infection (HCAIs). Monitoring the performance of disinfectants that are routinely used to clean hospital surfaces is critical for prevention and control of HCAIs. Nevertheless, the evaluation of the performance of disinfectants and their efficacy are not routinely practiced in most resource-limited countries. This study was designed to determine the efficacy of sodium dichloroisocyanurate (NaDCC) and chloroxylenol against American Type Culture Collection (ATCC) and their respective multidrug resistant (MDR) strains causing neonatal sepsis at a zonal referral hospital in Mwanza, Tanzania. Four ATCC (n = 4) and their respective MDR strains of Klebsiella pneumoniae, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa were used. The suspension test was used with contact time of 1, 5 and 10 min with starting concentration of 105 bacterial colony forming unit per milliliters (CFU/mL). The log10 reduction value at specified bacteria-disinfectant contact time was used to assess the efficacy of 0.5%NaDCC and 4.8% chloroxylenol in-use and freshly prepared solutions. In-use 0.5%NaDCC demonstrated poor log reduction (˂ 5log) against MDR-clinical isolates. Freshly laboratory prepared 0.5% NaDCC had 100% microbial reduction at 1, 5 and 10 min of both ATCC and MDR strains up to 48 h after preparation when compared with freshly prepared 4.8% chloroxylenol (˂ 5log). Freshly, prepared 0.5% NaDCC should be used in health-care facilities for effective disinfection practices.

Formulation development of chewable albendazole tablets with improved dissolution rate.

BACKGROUND: Albendazole is an orally administered broad-spectrum anthelmintic. Currently it is mostly used in the treatment of soil transmitted helminthes, hydatidosis and neurocysticercosis caused Taenia solium.Aim of the study. To develop and optimize a formulation of chewable albendazole tablet with improved dissolution rate. METHODOLOGY: This study was specifically focused on formulation development which passes compatibility studies and optimization of the developed formulation. The formulations were evaluated on assay, dissolution, friability, hardness, weight variation, disintegration and similarity in comparison with the reference product on the market. Analysis was required to be undertaken by High performance thin layer chromatography (HPTLC) analytical methods. Design of Expert version 7 software was used for selection or making scientific decisions in selecting the best composition of the best formulation. RESULTS: Five formulations out of ten (F-6, F-7, F-8, F-9 and F10) had all parameters in acceptable range. On optimization, one formulation with independent variables, Sodium Laury Sulphate (SLS) 1.911%, polyvinyl pyrrolidone (PVP-K30) 3.128%, and Sodium Cross carmellose (CCM) 4.95% was selected out of ten predictions made with Design expert version 7.0. It was found that assay of the best formulation is 99.23% which was within the in-house assay specification 95-105%. Dissolution single point in 30 min was found to be 91.5% disintegration between 2-5 min and friability 0.45%.The optimized formulation was tested and found to be within the acceptable limits. The formulation was comparable to the reference product on the market with similarity factor (f2) 62 and difference factor (f1) of 6 at pH1.2. CONCLUSION: A new generic albendazole tablet with improved dissolution rate was formulated, developed and optimized by using a wet granulation method.