Document Detail


Oral bioavailability of the antiretroviral agent 9-(2-phosphonylmethoxyethyl)adenine (PMEA) from three formulations of the prodrug bis(pivaloyloxymethyl)-PMEA in fasted male cynomolgus monkeys.
MedLine Citation:
PMID:  7937523     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The bioavailability of PMEA from three oral formulations of the prodrug bis(POM)-PMEA has been evaluated in fasted male cynomolgus monkeys. The formulations examined included a hydroxypropyl-beta-cyclodextrin (HPBCD) complex, a PEG based cosolvent solution, and an aqeous suspension. Oral formulations containing 3H-bis(POM)-PMEA were compared to intravenous 3H-PMEA at 10.9 mg-eq/kg in a crossover study in four monkeys, with a 7 day washout period. No intact bis(POM)-PMEA or monoester were detected in plasma. Bioavailabilities of PMEA from the prodrug were 24.7 +/- 6.5%, 27.3 +/- 12.3% and 22.2 +/- 15.6% for the HPBCD complex, PEG solution and aqueous suspension, respectively. The oral bioavailability of PMEA from bis(POM)-PMEA was not limited by dissolution rate of the prodrug. Data for the PEG cosolvent solution and suspension indicate that the prodrug could potentially be formulated as a soft gelatin capsule or a tablet.
Authors:
K C Cundy; J A Fishback; J P Shaw; M L Lee; K F Soike; G C Visor; W A Lee
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Pharmaceutical research     Volume:  11     ISSN:  0724-8741     ISO Abbreviation:  Pharm. Res.     Publication Date:  1994 Jun 
Date Detail:
Created Date:  1994-11-09     Completed Date:  1994-11-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8406521     Medline TA:  Pharm Res     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  839-43     Citation Subset:  IM    
Affiliation:
Gilead Sciences, Inc., Foster City, California 94404.
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MeSH Terms
Descriptor/Qualifier:
Adenine / administration & dosage,  analogs & derivatives*,  pharmacokinetics
Animals
Antiviral Agents / administration & dosage,  pharmacokinetics*
Biological Availability
Cyclodextrins
Macaca fascicularis
Male
Phosphonic Acids*
Prodrugs / administration & dosage,  pharmacokinetics*
Propylene Glycols
Retroviridae / drug effects
Suspensions
beta-Cyclodextrins*
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Cyclodextrins; 0/Phosphonic Acids; 0/Prodrugs; 0/Propylene Glycols; 0/Suspensions; 0/beta-Cyclodextrins; 0/bis(pivaloyloxymethyl)-9-(2-phosphonylmethoxyethyl)adenine; 106941-25-7/adefovir; 73-24-5/Adenine; 94035-02-6/2-hydroxypropyl-beta-cyclodextrin

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


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