Scale Up of Pan Coating Process Using Quality by Design Principles.

Abstract:

:Scale up of pan coating process is of high importance to the pharmaceutical and food industry. The number of process variables and their interdependence in a pan coating process can make it a rather complex scale-up problem. This review discusses breaking down the coating process variables into three main categories: pan-related, spray-related, and thermodynamic-related factors. A review on how to scale up each of these factors is presented via two distinct strategies--"macroscopic" and "microscopic" scale-up. In a Quality by Design paradigm, where an increased process understanding is required, there is increased emphasis on "microscopic" scale-up, which by definition ensures a more reproducible process and thereby robust scale-up. This article also reviews the various existing and new modeling and process analytical technology tools that can provide additional information to facilitate a more fundamental understanding of the coating process.

journal_name

J Pharm Sci

authors

Agrawal AM,Pandey P

doi

10.1002/jps.24582

subject

Has Abstract

pub_date

2015-11-01 00:00:00

pages

3589-3611

issue

11

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(16)30150-2

journal_volume

104

pub_type

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