Document Detail


Chiral analysis of d- and l-modafinil in human serum: application to human pharmacokinetic studies.
MedLine Citation:
PMID:  12657914     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Modafinil is a novel stimulant approved by the FDA for use in the management of excessive sleepiness associated with narcolepsy. Utility for other indications includes attention deficit-hyperactivity disorder (ADHD), depression, and management of cocaine dependence. To investigate the pharmacokinetics of modafinil in these patients, the authors improved and validated an HPLC method to separate and quantitate the separate enantiomers of modafinil in human serum. d- and l-Modafinil and the internal standard 3,3-diphenylpropylamine were extracted from serum, separated by gradient elution on a beta-cyclodextrin column, and then detected by UV absorbance at 225 nm. The elution gradient was developed to eliminate interferences by other drugs used to manage narcolepsy, ADHD, and stimulants of abuse, and endogenous substances in human serum. Validation studies included determination of stability, selectivity, precision, accuracy, and recovery. The method was used to investigate the pharmacokinetics of d- and l-modafinil in a volunteer after receiving 400 mg twice daily of racemic modafinil for 5 days. Interday and intraday assay variability (CV) typically ranged from 3% to 4%. The limits of detection (0.01 microg/mL) and quantitation (0.5 microg/mL) were well below the concentration expected in serum from patients receiving therapeutic doses of modafinil. The method was free from interference by methylphenidate, cocaine, commonly used antidepressants, and amphetamines. An example of apparent stereoselective disposition is presented as d-modafinil was eliminated more rapidly than l-modafinil from human serum. The validation data support the use of this method for human pharmacokinetic studies of modafinil in patients with known or suspected use of common antidepressants, psychostimulants, and drugs of abuse.
Authors:
Jennifer L Donovan; Robert J Malcolm; John S Markowitz; C Lindsay DeVane
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, U.S. Gov't, P.H.S.; Validation Studies    
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  25     ISSN:  0163-4356     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2003 Apr 
Date Detail:
Created Date:  2003-03-26     Completed Date:  2003-08-05     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  United States    
Other Details:
Languages:  eng     Pagination:  197-202     Citation Subset:  IM    
Affiliation:
Laboratory of Drug Disposition and Pharmacogenetics, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina 29425, USA.
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MeSH Terms
Descriptor/Qualifier:
Benzhydryl Compounds / blood*,  chemistry,  pharmacokinetics
Central Nervous System Stimulants / blood*,  chemistry,  pharmacokinetics
Chromatography, High Pressure Liquid
Cocaine / blood
Cocaine-Related Disorders / metabolism
Drug Interactions
Drug Stability
Humans
Male
Quality Control
Stereoisomerism
Grant Support
ID/Acronym/Agency:
M01 RR01070-18/RR/NCRR NIH HHS; N01 DA-9-8102/DA/NIDA NIH HHS
Chemical
Reg. No./Substance:
0/Benzhydryl Compounds; 0/Central Nervous System Stimulants; 50-36-2/Cocaine; 68693-11-8/modafinil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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