Abstract

USING QbD AND DOE APPROACH TO OPTIMIZE VARIOUS NOVEL FORMULATIONS- A MINI REVIEW

Shaveta Sharma*, Ashwani, Divya Rani Kashyap, Jyoti Singh and Vimal Arora

ABSTRACT

This review article outlines the overview of QbD and the DOE to the development of various formulations like liquisolid compacts, nanosystems, nanoemulsions, liposomes, etc. The first part consists of basic concept related to quality by design, implementation of QbD approach, risk analysis, pat technology. Secondly the development of various kinds of novel formulations by using QbD and DoE approach is discussed. This review article also gives outline of design of experiment along with the terminologies, historical perspectives, and steps for applying DoE for optimization of various formulations. Design of experiment is nothing but a structured, systemized method for optimization of formulation by developing the liaison between input and output response. The design of experiment begins with the predefined objectives, screening of factors, selection of influential factors, experimental design, formulation of drug delivery systems, computer aided modelling, validation of DOE methodology and final step is scale up on industrial scale. There are various kinds of experimental design which is used for screening, optimizing and developing of formulations or processes like factorial designs (full FDs, fractional FDs), Response surface methodologies (Central-Composite design, Box-Behnken design), Taguchi method, Star design, D-optimal design, etc. Now a day, various kinds of software have been developed which make it easy for formulation scientists to analyse and interpret the results. Design Expert®, OPTIMA®, DOE PRO XL®, STATISTICA®, NEMROD®, MODDE®, etc are most commonly used software.

Keywords: Design of Experiment, Quality by design, PAT technology, Factorial design, Central Composite Design, Box–Behnken Design.