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Importance of Raw Material Attributes for Modeling Ribbon and Granule Properties in Roller Compaction: Multivariate Analysis on Roll Gap and NIR Spectral Slope as Process Critical Control Parameters

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Abstract

This work is an extension of the earlier work from this laboratory aimed at identifying raw material properties critical to the modeling of granule and ribbon properties as part of the optimization of roller (RC) compaction processes. The utility of roll gap (RG) and near-infrared (NIR) signal, specifically, the spectral slope, as process critical control parameters (PCCPs) was also evaluated. Raw material tabletability, particle size, size distribution span, and tapped density were found to be most important factors for building robust predictive models. RG and NIR spectral slope in combination with RC operating parameters yielded models with good predictability for RC responses. Our results support the suitability of RG and NIR spectral slope as PCCPs in roller compaction, specifically, through ribbon density monitoring.

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Abbreviations

1/b :

Kawakita constant

a :

Kawakita constant

Bulk:

bulk density

C :

fractional powder volume reduction upon tapping

DoE:

design of experiment

Fall:

angle of fall

G/RM_PS:

ratio of granule to raw material particle size

G/RM_TTS:

ratio of granule to raw material tablet tensile strength

GMPS:

granule mean particle size

GTTS:

tensile strength of tablets made from granules

HFS:

horizontal feed screw speed

ICH:

International Conference on Harmonization

MCC:

microcrystalline cellulose

MCC Frac:

weight fraction of MCC in formulation

MgSt:

magnesium stearate

NIR:

near infrared

PAT:

process analytical technology

PC:

principal component

PCCP:

process critical control parameter

PLS:

partial least squares

PS:

particle size

QbD:

quality by design

RC:

roller compaction

RG:

roll gap

RMTTS:

raw material tablet tensile strength

RP:

roll pressure

RS:

roll speed

SF:

solid fraction

Span:

span in particle size distribution, \({\rm{Span = }}\frac{{X_{90} {\rm{ }} - {\rm{ }}X_{10} }}{{X_{50} }}\)

Tap:

tap density

VFS:

vertical feed screw speed

VIP:

variable importance on projection

V N :

powder volume after N taps

V o :

powder initial volume

ρ b :

powder bulk density

ρ t :

powder tap density

N :

number of taps

ε :

porosity

ρapp :

ribbon apparent density

σ t :

tensile strength

ρ T :

true density

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Acknowledgment

The authors thank the Consortium for the Advancement of Manufacturing of Pharmaceuticals (CAMP) for the funding of this work and especially Novartis Pharmaceuticals Corporation for providing the facilities where the roller compaction work was performed. Students from the Massachusetts Institute of Technology (MIT) Practice School are acknowledged for the help in the roller compaction. The assistance of Victor Hildebrand in the characterization work is also appreciated. A special gratitude is extended to Professor Rodolfo Romañach, University of Puerto Rico at Mayagüez, for stimulating discussions on this research.

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Authors and Affiliations

  1. Department of Industrial and Physical Pharmacy, School of Pharmacy and Pharmaceutical Sciences, Purdue University, 575 Stadium Mall Drive, West Lafayette, IN, 47907, USA

    Josephine L. P. Soh, Nathan Boersen, M. Teresa Carvajal, Kenneth R. Morris, Garnet E. Peck & Rodolfo Pinal

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  1. Josephine L. P. Soh
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  2. Nathan Boersen
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  3. M. Teresa Carvajal
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  4. Kenneth R. Morris
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  5. Garnet E. Peck
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  6. Rodolfo Pinal
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Correspondence to Rodolfo Pinal.

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Soh, J.L.P., Boersen, N., Carvajal, M.T. et al. Importance of Raw Material Attributes for Modeling Ribbon and Granule Properties in Roller Compaction: Multivariate Analysis on Roll Gap and NIR Spectral Slope as Process Critical Control Parameters. J Pharm Innov 2, 106–124 (2007). https://doi.org/10.1007/s12247-007-9013-z

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  • DOI: https://doi.org/10.1007/s12247-007-9013-z

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