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Impact of microcrystalline cellulose material attributes: a case study on continuous twin screw granulation.
Int J Pharm. 2015 Jan 30; 478(2):705-17.IJ

Abstract

The International Conference on Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of material attributes, manufacturing process options and process parameters. The present case study evaluates the effect of unspecified variability of raw material properties upon the quality attributes of granules; produced using a continuous from-powder-to-tablet wet granulation line (ConsiGma™ 25). The impact of different material attributes of six samples of microcrystalline cellulose (MCC) was investigated. During a blind study the different samples of MCC were used separately and the resulting granules were evaluated in order to identify the differences between the six samples. Variation in size distribution due to varying water binding capacity of the MCC samples was observed. The cause of this different water binding capacity was investigated and was caused by a different degree of crystallinity. Afterwards, an experimental design was conducted in order to evaluate the effect of both product and process variability upon the granule size distribution. This model was used in order to calculate the required process parameters to obtain a preset granule size distribution regardless of the type of MCC used. The difference in water binding capacity and its effect on granular properties was still present when combining the MCC grades with different binders.

Authors+Show Affiliations

Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Margot.Fonteyne@Ugent.be.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium.Department of Pharmaceutical Technology, University of Ljubljana, Aškerčeva 7, Ljubljana, Slovenia.Division of Glycoscience, School of Biotechnology, Royal Institute of Technology (KTH), AlbaNova University Centre, Stockholm, Sweden.Laboratory of Pharmaceutical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium.FMC R&D and Application Center, Avenue Mounier 83, Brussels, Belgium.Division of Glycoscience, School of Biotechnology, Royal Institute of Technology (KTH), AlbaNova University Centre, Stockholm, Sweden.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Thomas.DeBeer@Ugent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25479098

Citation

Fonteyne, Margot, et al. "Impact of Microcrystalline Cellulose Material Attributes: a Case Study On Continuous Twin Screw Granulation." International Journal of Pharmaceutics, vol. 478, no. 2, 2015, pp. 705-17.
Fonteyne M, Correia A, De Plecker S, et al. Impact of microcrystalline cellulose material attributes: a case study on continuous twin screw granulation. Int J Pharm. 2015;478(2):705-17.
Fonteyne, M., Correia, A., De Plecker, S., Vercruysse, J., Ilić, I., Zhou, Q., Vervaet, C., Remon, J. P., Onofre, F., Bulone, V., & De Beer, T. (2015). Impact of microcrystalline cellulose material attributes: a case study on continuous twin screw granulation. International Journal of Pharmaceutics, 478(2), 705-17. https://doi.org/10.1016/j.ijpharm.2014.11.070
Fonteyne M, et al. Impact of Microcrystalline Cellulose Material Attributes: a Case Study On Continuous Twin Screw Granulation. Int J Pharm. 2015 Jan 30;478(2):705-17. PubMed PMID: 25479098.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of microcrystalline cellulose material attributes: a case study on continuous twin screw granulation. AU - Fonteyne,Margot, AU - Correia,Ana, AU - De Plecker,Sofie, AU - Vercruysse,Jurgen, AU - Ilić,Ilija, AU - Zhou,Qi, AU - Vervaet,Chris, AU - Remon,Jean Paul, AU - Onofre,Fernanda, AU - Bulone,Vincent, AU - De Beer,Thomas, Y1 - 2014/12/03/ PY - 2014/08/27/received PY - 2014/11/27/revised PY - 2014/11/29/accepted PY - 2014/12/6/entrez PY - 2014/12/6/pubmed PY - 2015/9/29/medline KW - MCC KW - Quality by design KW - Raw material variability KW - Twin screw granulation KW - Water binding capacity SP - 705 EP - 17 JF - International journal of pharmaceutics JO - Int J Pharm VL - 478 IS - 2 N2 - The International Conference on Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of material attributes, manufacturing process options and process parameters. The present case study evaluates the effect of unspecified variability of raw material properties upon the quality attributes of granules; produced using a continuous from-powder-to-tablet wet granulation line (ConsiGma™ 25). The impact of different material attributes of six samples of microcrystalline cellulose (MCC) was investigated. During a blind study the different samples of MCC were used separately and the resulting granules were evaluated in order to identify the differences between the six samples. Variation in size distribution due to varying water binding capacity of the MCC samples was observed. The cause of this different water binding capacity was investigated and was caused by a different degree of crystallinity. Afterwards, an experimental design was conducted in order to evaluate the effect of both product and process variability upon the granule size distribution. This model was used in order to calculate the required process parameters to obtain a preset granule size distribution regardless of the type of MCC used. The difference in water binding capacity and its effect on granular properties was still present when combining the MCC grades with different binders. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/25479098/Impact_of_microcrystalline_cellulose_material_attributes:_a_case_study_on_continuous_twin_screw_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(14)00885-0 DB - PRIME DP - Unbound Medicine ER -