Document Detail


Co-administration of darunavir and a new pharmacokinetic booster: formulation strategies and evaluation in dogs.
MedLine Citation:
PMID:  20685614     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Various formulations for combination of the anti-HIV protease inhibitor darunavir (DRV) and TMC41629, a pharmacokinetic booster for DRV, were studied. TMC41629 (a BCS-IV compound) was formulated in capsules, as polyethylene glycol 400 (PEG400) solution, binary or ternary self-microemulsifying drug delivery system (SMEDDS), inclusion complex with hydroxypropyl-beta-cyclodextrin (HPbetaCD) or polyvinylpyrrolidone-co-vinylacetate 64 (PVP/VA64) extrudate. In addition, tablets were prepared using unmilled or micronized powder and a disintegrant. On co-administration with DRV tablets in dogs, DRV plasma concentration levels were boosted by TMC41629, the PVP/VA64 extrudate achieving the highest DRV levels (2-fold increase). Yet, with extrudate prepared with both compounds, no boosting effect was observed, likely due to transition of DRV from crystalline solvate to amorphous state. Therefore, a co-formulation, combining DRV as crystalline solvate with amorphous TMC41629, was developed. DRV/kappa-carrageenan 80/20% (w/w) beads coated with TMC41629 released at least 80% within 1h in 0.01M HCl with 0.5% sodium lauryl sulphate, TMC41629 dissolving faster than DRV. In dogs, the DRV exposure increased 2.7-fold with the TMC41629-coated beads relative to DRV alone, yet remained lower, but less variable, than following co-administration as separate formulations. Coating of TMC41629 on DRV/kappa-carrageenan beads is a suitable technique for co-formulation, whereby TMC41629 can function as a booster of DRV.
Authors:
Elke Van Gyseghem; Lieven Baert; Pieter Van Remoortere; Gerben van 't Klooster; Marie-Claude Rouan; Jody Voorspoels; Herman de Kock; Laurent Schueller; Jan Rosier; Liesbeth Grooten; Guy Van den Mooter
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Publication Detail:
Type:  Journal Article     Date:  2010-06-08
Journal Detail:
Title:  European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences     Volume:  41     ISSN:  1879-0720     ISO Abbreviation:  Eur J Pharm Sci     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-08-23     Completed Date:  2010-12-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9317982     Medline TA:  Eur J Pharm Sci     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  193-200     Citation Subset:  IM    
Affiliation:
Laboratorium voor Farmacotechnologie en Biofarmacie, Katholieke Universiteit Leuven, Leuven, Belgium.
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MeSH Terms
Descriptor/Qualifier:
Animals
Chemistry, Pharmaceutical
Dogs
HIV Protease Inhibitors / administration & dosage*,  pharmacokinetics
Sulfonamides / administration & dosage*,  pharmacokinetics
Tablets
Chemical
Reg. No./Substance:
0/HIV Protease Inhibitors; 0/Sulfonamides; 0/Tablets; 0/darunavir

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