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QUALITY BY DESIGN (QBD) ASSISTED STATISTICAL MODELLING AND EX VIVO PERMEATION STUDY OF OLANZAPINE LOADED MICROEMULSION
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| Author:
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MANISH UPADHYAY, VIJAY GHORI, M.M.SONIWALA
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| Abstract:
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The present study was aimed towards development and characterization of Olanzapine (OZ) loaded microemulsion
(ME) for brain delivery through nasal route. More emphasize was given in the present work is application of QbD
tools and DoE approach. Different QTPP and CQAs were identified initially and REM was prepared. Further D
optimal design was employed with concentration of Oil (A;X1), concentration of Smix (B;X2) and concentration of
water (C;X3) as significant independent variables (IVs). Globule size (Y1), %Transmittance (Y2) and Viscosity (Y3)
were kept as important CQAs. MLR models revealed that selected IVs have great impact on Y1 and Y3, specially main
and interactive effect. The results were supported by contour plots (2D and3D) and predicated Vs actual plot.% PE
values for check point batches were found less than 5% indicating accuracy of evolved MLR models. Further, control
space was mapped from design space of overlay plot and out of control space, one batch was optimized and revised
REM was prepared. Revised REM showed low risk potential of various IVs on selected CQAs.Optimized batch was
tested for ex vivo permeation using sheep nasal mucosa in SNF. The study revealed that superior permeation than OZ
suspension which is attributed to the incorporation of OZ into ME carrier. So, in a nutshell, it can be concluded that
application of QbD tools and DoE concepts in OZ loaded ME yielded risk free control space which will be useful for
error free scale up plan execution.
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| Keyword:
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Olanzapine, QbD, Risk assessment, DoE, Control space
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2019.11.03.016
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| Download:
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