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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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QUALITY BY DESIGN (QBD) ASSISTED STATISTICAL MODELLING AND EX VIVO PERMEATION STUDY OF OLANZAPINE LOADED MICROEMULSION

Author: MANISH UPADHYAY, VIJAY GHORI, M.M.SONIWALA
Abstract: 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.
Keyword: Olanzapine, QbD, Risk assessment, DoE, Control space
DOI: https://doi.org/10.31838/ijpr/2019.11.03.016
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