Bioequivalence of two pregabalin 300 mg capsules (Neurexal and Lyrica®) in healthy human volunteers.

The pharmacokinetics of 2 brands of pregabalin 300 mg capsules were compared in 23 healthy human volunteers after a single oral dose in a randomized cross-over study. The study protocol was prepared with relevance to the requirements set in the US FDA and the EMA guidances for conduction of bioequivalence studies. Reference (Lyrica(®), Pfizer, France) and test (Neurexal, Pharmaline, Lebanon) products were administered to fasted volunteers. Blood samples were collected up to 48 h and assayed for pregabalin using a validated LC-MS/MS method. The pharmacokinetic parameters AUC0-t, AUC0-∞, Cmax, Tmax, T1/2 and elimination rate constant were determined from plasma concentration-time profile by non-compartmental analysis method using WinNonlin V5.2. The analysis of variance did not show any significant difference between the 2 formulations and 90% confidence intervals fell within the acceptable range for bioequivalence: 80-125%. It was concluded that the 2 brands exhibited comparable pharmacokinetic profiles and that Pharmaline's Neurexal is bioequivalent to Lyrica(®) of Pfizer, France.

VIM-4 carbapenemase-producing Enterobacter cloacae in the United Arab Emirates.

Screening 34 carbapenem non-susceptible Enterobacteriaceae recovered in Abu Dhabi hospitals identified an Enterobacter cloacae strain carrying bla(VIM-4) , bla(CMY-4) and bla(CTX-M-15) . It was isolated from the urine of an Egyptian patient repeatedly hospitalized and treated with broad-spectrum antibiotics, including carbapenems, in the United Arab Emirates. The bla(VIM-4) coding class I integron, highly similar to In416, was carried on a 175-kilobase non-conjugative incA/C type plasmid also hybridizing with the bla(CMY-4) probe. This is the first detailed report on the isolation of a Verona integron-encoded metallo-ß-lactamase (VIM) -producing enteric bacterium in the Arabian Peninsula with characteristics suggestive of spreading from the Mediterranean region.

NDM-2 carbapenemase-producing Acinetobacter baumannii in the United Arab Emirates.

Screening 155 carbapenem non-susceptible Acinetobacter baumannii strains recovered in Abu Dhabi hospitals identified two metallo-ß-lactamase bla(NDM) gene-carrying isolates. They were isolated 4 months apart from the urine of a cancer patient previously treated in Egypt, Lebanon and in the United Arab Emirates. They were clonally related and carried the bla(NDM-2) gene recently identified in A. baumannii in Egypt and Israel. Sequences surrounding the bla(NDM-2) gene showed significant similarities with those associated with bla(NDM-1) in Enterobacteriaceae and A. baumannii. Repeated isolation of bla(NDM-2)-positive A. baumannii in the Middle East raises the possibility of the local emergence and spread of a unique clone.

Decoupling of bilateral paraspinal excitation in subjects with low back pain.

This study compared bilateral paraspinal excitation in normal subjects and subjects with low back pain. Comparison was made between six control subjects and seven low back pain subjects who performed maximum-effort isometric trunk extension in minimum elapsed time at two trunk angles. Electromyographic signals were collected bilaterally from the paraspinal musculature. The time- and amplitude-normalized electromyographic data were analyzed using a repeatability criterion sensitive to temporal and amplitude differences. This analysis showed that low back pain subjects demonstrated temporal and amplitude decoupling of the paraspinal musculature bilaterally. Low back pain subjects also demonstrated clinically meaningful disruptions between paraspinal excitation and isometric trunk extension moment. This method may be useful in quantifying neuromotor control in low back pain for initial and follow-up clinical evaluation for static and dynamic functional tests.