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IVIVC from Long Acting Olanzapine Microspheres

Authors: Susan D'Souza; Jabar A. Faraj; Stefano Giovagnoli; Patrick P. DeLuca;

IVIVC from Long Acting Olanzapine Microspheres

Abstract

In this study, four PLGA microsphere formulations of Olanzapine were characterized on the basis of theirin vitrobehavior at 37°C, using a dialysis based method, with the goal of obtaining an IVIVC.In vivoprofiles were determined by deconvolution (Nelson-Wagner method) and using fractional AUC. Thein vitroandin vivorelease profiles exhibited the same rank order of drug release. Further,in vivoprofiles obtained with both approaches were nearly superimposable, suggesting that fractional AUC could be used as an alternative to the Nelson-Wagner method. A comparison of drug release profiles for the four formulations revealed that thein vitroprofile lagged slightly behindin vivorelease, but the results were not statistically significant (P<0.0001). Using the four formulations that exhibited different release rates, a Level A IVIVC was established using the deconvolution and fractional AUC approaches. A nearly 1 : 1 correlation (R2>0.96) betweenin vitrorelease andin vivomeasurements confirmed the excellent relationship betweenin vitrodrug release and the amount of drug absorbedin vivo. The results of this study suggest that proper selection of anin vitromethod will greatly aid in establishing a Level A IVIVC for long acting injectables.

Country
Italy
Keywords

TP248.13-248.65, Biotechnology, Research Article

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    54
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
54
Top 10%
Top 10%
Top 10%
Green
gold