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Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V (2014-02-08)
P Avalle, M J Pollitt, K Bradley, B Cooper, G Pearce, A Djemai, S Fitzpatrick
ABSTRACT

This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps, development of a Process Analytical Technology (PAT) method is discussed and also a novel application of automated microscopy as the reference method. Ultimately, PAT methods should link to product performance and the two key Critical Quality Attributes (CQAs) for this CR product are assay and release rate, linked to the API and CR coating steps respectively. In this work, the link between near infra-red (NIR) spectra and those attributes was explored by chemometrics over the course of the coating process in a pilot scale industrial environment. Correlations were built between the NIR spectra and coating weight (for API amount), CR coating thickness and dissolution performance. These correlations allow the coating process to be monitored at-line and so better control of the product performance in line with QbD requirements.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Sucrose, for molecular biology, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, BioXtra, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, BioUltra, for molecular biology, ≥99.5% (HPLC)
Sigma-Aldrich
Sucrose, ≥99.5%
Supelco
Sucrose, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Sucrose, puriss., meets analytical specification of Ph. Eur., BP, NF
Sigma-Aldrich
Sucrose, ACS reagent
Sigma-Aldrich
Sucrose, BioReagent, suitable for cell culture, suitable for insect cell culture, ≥99.5% (GC)
Millipore
Sucrose, suitable for microbiology, ACS reagent, ≥99.0%
USP
Sucrose, United States Pharmacopeia (USP) Reference Standard
Supelco
Sucrose, analytical standard
Sigma-Aldrich
Sucrose, meets USP testing specifications
Sigma-Aldrich
Sucrose, Grade II, suitable for plant cell culture
Sucrose, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Sucrose, Grade I, suitable for plant cell culture
Supelco
Sucrose, analytical standard, for enzymatic assay kit SCA20