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Near-infrared chemical imaging (NIR-CI) on roll compacted ribbons and tablets - multivariate mapping of physical and chemical properties
Umeå University, Faculty of Science and Technology, Department of Chemistry.
Umeå University, Faculty of Science and Technology, Department of Chemistry.
Umeå University, Faculty of Science and Technology, Department of Chemistry.
2015 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, E-ISSN 1873-3476, Vol. 483, no 1-2, 200-211 p.Article in journal (Refereed) Published
Abstract [en]

Near-infrared chemical imaging (NIR-CI) is an attractive technique within the pharmaceutical industry, where tools are continuously in demand to assess the quality of the intermediate and final products. The present paper demonstrates how NIR-CI in combination with multivariate methods was utilized to spatially map physical properties and content of roll compacted ribbons and tablets. Additionally, extracted textural parameters from tablet images were correlated to the design parameters of the roll compaction process as well as to the physical properties of the granules. The results established the use of NIR-CI as a complementary nondestructive tool to determine the ribbon density and map the density distribution across the width and along the length of the ribbons. For the tablets, the compaction pressure developed during compression increased with the lateral distance from the center. Therefore, NIR-CI can be an effective tool to provide information about the spatial distribution of the compaction pressures on the surface of the tablet. Moreover, low roll compaction roll force correlated to a heterogeneous type of texture in the API chemical image. Overall, texture analysis of the tablets enabled efficient investigation of the spatial variation and could be used to advance process understanding. Finally, orthogonal projections to latent structures (O2PLS) model facilitated the understanding of the interrelationships between textural features, design parameters and physical properties data by separately joint and unique variations.

Place, publisher, year, edition, pages
2015. Vol. 483, no 1-2, 200-211 p.
Keyword [en]
Near-infrared chemical imaging, Roll compaction, Orthogonal projections to latent structures (O2PLS), Grey-level co-occurrence matrices, Texture analysis
National Category
Other Chemistry Topics
Identifiers
URN: urn:nbn:se:umu:diva-96433DOI: 10.1016/j.ijpharm.2015.02.006ISI: 000350454200023OAI: oai:DiVA.org:umu-96433DiVA: diva2:764668
Available from: 2014-11-20 Created: 2014-11-20 Last updated: 2017-12-05Bibliographically approved
In thesis
1. Multivariate Synergies in Pharmaceutical Roll Compaction: The quality influence of raw materials and process parameters by design of experiments
Open this publication in new window or tab >>Multivariate Synergies in Pharmaceutical Roll Compaction: The quality influence of raw materials and process parameters by design of experiments
2014 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Roll compaction is a continuous process commonly used in the pharmaceutical industry for dry granulation of moisture and heat sensitive powder blends. It is intended to increase bulk density and improve flowability. Roll compaction is a complex process that depends on many factors, such as feed powder properties, processing conditions and system layout. Some of the variability in the process remains unexplained. Accordingly, modeling tools are needed to understand the properties and the interrelations between raw materials, process parameters and the quality of the product. It is important to look at the whole manufacturing chain from raw materials to tablet properties.

The main objective of this thesis was to investigate the impact of raw materials, process parameters and system design variations on the quality of intermediate and final roll compaction products, as well as their interrelations. In order to do so, we have conducted a series of systematic experimental studies and utilized chemometric tools, such as design of experiments, latent variable models (i.e. PCA, OPLS and O2PLS) as well as mechanistic models based on the rolling theory of granular solids developed by Johanson (1965).

More specifically, we have developed a modeling approach to elucidate the influence of different brittle filler qualities of mannitol and dicalcium phosphate and their physical properties (i.e. flowability, particle size and compactability) on intermediate and final product quality. This approach allows the possibility of introducing new fillers without additional experiments, provided that they are within the previously mapped design space. Additionally, this approach is generic and could be extended beyond fillers. Furthermore, in contrast to many other materials, the results revealed that some qualities of the investigated fillers demonstrated improved compactability following roll compaction.

In one study, we identified the design space for a roll compaction process using a risk-based approach. The influence of process parameters (i.e. roll force, roll speed, roll gap and milling screen size) on different ribbon, granule and tablet properties was evaluated. In another study, we demonstrated the significant added value of the combination of near-infrared chemical imaging, texture analysis and multivariate methods in the quality assessment of the intermediate and final roll compaction products. Finally, we have also studied the roll compaction of an intermediate drug load formulation at different scales and using roll compactors with different feed screw mechanisms (i.e. horizontal and vertical). The horizontal feed screw roll compactor was also equipped with an instrumented roll technology allowing the measurement of normal stress on ribbon. Ribbon porosity was primarily found to be a function of normal stress, exhibiting a quadratic relationship. A similar quadratic relationship was also observed between roll force and ribbon porosity of the vertically fed roll compactor. A combination of design of experiments, latent variable and mechanistic models led to a better understanding of the critical process parameters and showed that scale up/transfer between equipment is feasible.

Place, publisher, year, edition, pages
Umeå: Umeå University, 2014. 69 p.
Keyword
Roll compaction, dry granulation, mannitol, dicalcium phosphate, design of experiments, orthogonal projections to latent structures, critical quality attributes, tablet manufacturing, quality by design, design space, near-infrared chemical imaging, texture analysis, modeling, scale up, instrumented roll, Johanson model
National Category
Other Chemistry Topics Pharmaceutical Sciences
Identifiers
urn:nbn:se:umu:diva-96441 (URN)978-91-7601-162-1 (ISBN)
Public defence
2014-12-12, KB3A9, KBC-huset, Umeå universitet, Umeå, 10:00 (English)
Opponent
Supervisors
Available from: 2014-11-21 Created: 2014-11-20 Last updated: 2014-11-21Bibliographically approved

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