Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a Quality by Design (QbD) approach

Date

2018-09-19

Advisors

Journal Title

Journal ISSN

ISSN

0363-9045

Volume Title

Publisher

Taylor and Francis

Type

Article

Peer reviewed

Yes

Abstract

Screw feeder performance is a critical aspect in continuous manufacturing processes. Pharmaceutical excipients, such as mannitol, microcrystalline cellulose, lactose monohydrate, and anhydrous dibasic calcium phosphate can present problems in ensuring a continuous stable feed rate due to their sub-optimal flow properties. In alignment with Quality by Design (QbD) goals, the aim of this work was to identify and explain critical sources of variability of some powder excipients delivery by screw feeding, in particular to continuous processing lines. Pharmaceutical excipients with a wide range of material properties were selected, and the impact of their flow and density properties on screw feeder performance was investigated. The analysis of the powder conveying by the screws was performed at different hopper fills and different screw speeds. A multivariable model involving bulk density (CBD) and parameters from FT4 dynamic downwards testing (SI) and dynamic upwards testing (SE) explained 95.7% of excipients feed rates (p<.001). The study gathers valuable information about the screw feeder performance and input materials properties that can help process understanding and QbD-based development of solid dosage forms in continuous processing lines.

Description

The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link.

Keywords

Quality by Design, Screw feeder performance, Excipients properties

Citation

Santos, B., Carmo, F., Schlindwein, W., Muirhead, G., Rodrigues, C., Cabral, L., Westrup, J. and Pitt, K. (2018) Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a Quality by Design (QbD) approach. Drug Development and Industrial Pharmacy, 44 (12), pp.

Rights

Research Institute

Leicester Institute for Pharmaceutical Innovation - From Molecules to Practice (LIPI)