Int J Clin Pharm Th
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Int J Clin Pharm Th · Feb 2010
Randomized Controlled Trial Comparative StudyPharmacokinetic comparisons of three nasal fentanyl formulations; pectin, chitosan and chitosan-poloxamer 188.
To optimize the absorption profile and reduce C(max), three new fentanyl nasal spray formulations have been developed: fentanyl pectin (FPNS), fentanyl chitosan (FChNS) and fentanyl in chitosan-poloxamer 188 (FChPNS). The venous pharmacokinetic profiles and tolerability of these formulations were assessed and compared with oral transmucosal fentanyl citrate (OTFC) lozenge. ⋯ All nasal formulations demonstrated significantly increased systemic exposure and reduced times to peak plasma values compared with OTFC. The FPNS formulation exhibited the most favorable nasal and general tolerability profiles. It appears suitable for further investigation in breakthrough cancer pain management.
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Int J Clin Pharm Th · Feb 2010
Randomized Controlled Trial Comparative StudyDifferences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration.
This study was designed to evaluate and compare the bioavailability of two osmotically active formulations of 60 mg nifedipine, Gen-Nifedipine extended release Test tablets (Genpharm ULC, Etobicoke, ON, Canada) and Adalat XL Reference tablets (Bayer Healthcare AG, Leverkusen, Germany) after single dose fasted and fed administration. ⋯ The results indicate that although both products are osmotic release systems they are not bioequivalent according to the accepted standards. This difference between both osmotic delivery systems might be substantiated by the fact that the core of the Test product is designed as a monolayer system (containing both, the active ingredient and the osmotic component) while Reference tablets consist of two separate layers. The observed pharmacokinetic differences may have an impact on blood pressure control in patients and thus, should be kept in mind when switching during treatment.
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Int J Clin Pharm Th · Feb 2010
Randomized Controlled TrialThe effect of food with varying fat content on the clinical pharmacokinetics of gabapentin after oral administration of gabapentin enacarbil.
Gabapentin enacarbil, an actively transported prodrug of gabapentin, provides sustained and dose-proportional exposure to gabapentin. ⋯ Administration of gabapentin enacarbil with food enhanced gabapentin exposure compared with fasted conditions, regardless of the fat or caloric content, and gabapentin enacarbil was generally well tolerated.
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Int J Clin Pharm Th · Jan 2010
Controlled Clinical TrialPopulation pharmacokinetic study of methotrexate in children with acute lymphoblastic leukemia.
A population pharmacokinetic model was developed to describe the factors that may affect the pharmacokinetics of methotrexate (MTX) in Chinese child patients with acute lymphoid leukemia (ALL) and to predict the individual pharmacokinetic parameters in these patients. One hundred and eighteen children with ALL who received MTX at the dose of 2 - 3.5 g/m(2) were enrolled in this study. 96 children were enrolled in the index group and 22 children in the validation group. The data were analyzed using nonlinear mixed effect model (NONMEM) software. ⋯ Moreover, some secondary pharmacokinetic parameters were estimated: the elimination half-life t1/2 was 2.34 h (CV = 36.7%), elimination constant k(e) was 0.33 h(-1) (CV = 33.2%), and the area under plasma concentration versus time curve AUC was 582.92 mg x h x l(-1) (CV = 55.9%). Our model combine Bayesian approach enabled a satisfactory estimation of MTX concentration in individual patients. The results of this study allowed clinicians to assess the MTX pharmacokinetic parameters based on the specific demographic characteristics of patients.