Karhu D.,Labopharm |
Groenewoud G.,PAREXEL |
Potgieter M.A.,PAREXEL |
Mould D.R.,Projections Research Inc.
Journal of Clinical Pharmacology
An extended-release trazodone HCl formulation, Trazodone Contramid OAD (TzCOAD), was developed as scored 150-mg and 300-mg caplets for once-daily administration. Dose proportionality of intact and bisected caplets (dose range, 75-375 mg) was evaluated in a single-dose, randomized, 5-way crossover study. Plasma trazodone and m-chlorophenylpiperazine (mCPP) levels were determined using a validated liquid chromatography-tandem mass spectroscopy method. Dose proportionality was assessed based on confidence intervals for logarithmically transformed, dose-normalized maximum plasma concentration (C max), area under the plasma concentration versus time data pairs (AUC 0-t), and area under the curve from time 0 to infinity (AUC 0-∞) in relation to the acceptance range of 80% to 125% (bioequivalence approach). The power method, combined with confidence interval criteria, was also used to assess proportionality. The conclusion of dose proportionality was generally supported using the bioequivalence approach. Based on the power model, values of the slope and corresponding 90% confidence interval for trazodone C max, AUC 0-t, and AUC 0-∞ were 0.948 (0.899-0.997), 0.920 (0.875-0.964), and 0.913 (0.867-0.958), respectively. All were within the acceptance interval (0.861-1.139). Results for mCPP also fell within the acceptance interval. TzCOAD exhibits linear pharmacokinetics over doses ranging from 75 to 375 mg and maintains its controlled-release properties when the caplets are bisected along the score line. © 2010 The Author(s). Source
Paladin Labs and Labopharm | Date: 2011-10-04
Modified starch used in the manufacture of pharmaceutical products as an agent for controlled or sustained release drug delivery for oral and parenteral administration.
Labopharm | Date: 2009-05-11
Labopharm | Date: 2009-05-11
Pharmaceutical preparations, namely, a solid oral tablet allowing for the controlled or sustained release of pharmaceutical agents contained within into the body; Pharmaceutical drug delivery systems, namely, drug delivery formulations used with various medications for controlled or sustained release of medication into the body.
Duan D.X.,Agriculture and Agri Food Canada |
Donner E.,Agriculture and Agri Food Canada |
Donner E.,Eyegenix LLC |
Liu Q.,Agriculture and Agri Food Canada |
And 3 more authors.
Amylose, the amount of which varies significantly depending on the source, is one of the key components of starch. The proportion of the essentially linear amylose and the highly branched amylopectin greatly influences the physico-chemical properties of starch. In this study, potentiometric titration using an auto-titrator and colorimetric methods were compared for determining amylose contents of a variety of starch samples. Potentiometric titration results for starches from a variety of botanical sources were within the reported literature ranges while the colorimetric method seemed to overestimate amylose content. © 2011 Published by Elsevier Ltd. All rights reserved. Source