ABSTRACT
OBJECTIVE: The objective of this study was to compare pharmacokinetic parameters of niacin extended-release tablets (NER uncoated) and niacin extended-release caplet formation (NER coated). RESEARCH DESIGN AND METHODS: Twenty-five healthy male and female subjects were enrolled in a four-period, open-label, randomized, crossover study. Both NER uncoated and NER coated were given as 1 x 1000 mg or 2 x 500 mg tablets. Similarity of NER coated 1 x 1000 mg and NER uncoated 2 x 500 mg was declared if 90% confidence intervals for the geometric mean ratio (GMR) for nicotinuric acid (NUA) Cmax fell within the pre-specified bounds of [0.7, 1.43]. RESULTS: The GMRs for NUA Cmax demonstrated similarity in the pharmacokinetics of NER uncoated 2 x 500 mg, NER coated 1 x 1000 mg, and NER coated 2 x 500 mg. Although less stringent comparability bounds were prespecified for the primary pharmacokinetic endpoint (i.e., Cmax of plasma NUA), inspection of the primary comparison of interest indicated that a hypothesis with more stringent bioequivalence bounds of [0.8, 1.25] would have been satisfied. The NUA Cmax for NER uncoated 1 x 1000 mg was approximately 40% higher than that seen for the other three treatments. In contrast, total urinary excretion of niacin and its metabolites, an approximate measure of bioavailability, was similar for all four treatments. CONCLUSION: The pharmacokinetic profile of the original NER uncoated formulation dosed as 2 x 500 mg was similar to the new film-coated formulation, NER coated, dosed as 1 x 1000 mg.
Subject(s)
Niacin/pharmacokinetics , Adult , Area Under Curve , Biological Availability , Cross-Over Studies , Delayed-Action Preparations , Female , Humans , Male , Middle Aged , Niacin/administration & dosage , Niacin/blood , Niacin/urineABSTRACT
A simple and rapid bioautographic enzyme assay on TLC plates has been developed for the screening of acetylcholinesterase and butyrylcholinesterase inhibition by plant extracts. Enzyme activity was detected by the conversion of naphthyl acetate into naphthol and the formation of the corresponding purple-coloured diazonium dye with Fast Blue B salt. Inhibitors of cholinesterases produced white spots on the dye-coloured background of the TLC plates. The alkaloids galanthamine and physostigmine, which are known inhibitors of acetylcholinesterase, were used to determine the sensitivity of the assay. Various plant extracts were tested using the bioassay.
Subject(s)
Acetylcholinesterase/metabolism , Biological Assay/methods , Butyrylcholinesterase/metabolism , Cholinesterase Inhibitors/analysis , Chromatography, Thin Layer/methods , Plants/chemistry , Molecular Structure , Naphthaleneacetic Acids , Sensitivity and SpecificityABSTRACT
A total of 451 strains of gram-positive bacteria were identified with a prototype of the Gram-Positive Identification card used in conjunction with the AutoMicrobic system (Vitek Systems, Inc., Hazelwood, Mo.). Of the species that the Gram-Positive Identification card is capable of identifying, 85% of staphylococcal, 50% of beta-hemolytic group A, B, C, F, and G streptococcal, 91% of group D streptococcal, 100% of pneumococcal, 63% of viridans streptococcal, and 100% of Listeria monocytogenes strains tested displayed Gram-Positive Identification card identifications that were in agreement with identifications obtained by conventional methods.
