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Statistical analysis and comparison of a continuous high shear granulator with a twin screw granulator: Effect of process parameters on critical granule attributes and granulation mechanisms.
Int J Pharm. 2016 Nov 20; 513(1-2):357-375.IJ

Abstract

This study is concerned with identifying the design space of two different continuous granulators and their respective granulation mechanisms. Performance of a continuous high shear granulator and a twin screw granulator with paracetamol formulations were examined by face-centered cubic design, which focused on investigating key performance metrics, namely, granule size, porosity, flowability and particle morphology of granules as a function of essential input process parameters (liquid content, throughput and rotation speed). Liquid and residence time distribution tests were also performed to gain insights into the liquid-powder mixing and flow behavior. The results indicated that continuous high shear granulation was more sensitive to process variation and produced spherical granules with monomodal size distribution and distinct internal structure and strength variation. Twin screw granulation with such a particular screw configuration showed narrower design space and granules were featured with multimodal size distribution, irregular shape, less detectible porosity difference and tighter range of strength. Granulation mechanisms explored on the basis of nucleation and growth regime maps revealed that for most cases liquid binder was uniformly distributed with fast droplet penetration into the powder bed and that granule consolidation and coalescence mainly took place in the nucleation, steady growth and rapid growth regimes.

Authors+Show Affiliations

Department of Pharmaceutics, Rutgers University, Piscataway, NJ 08854, USA.Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ 08854, USA.Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ 08854, USA.Eli Lilly and Company, Indianapolis, IN 46225, USA.School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA.Hüttlin GmbH - A Bosch Packaging Technology Company, 79650 Schopfheim, Germany.School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA; Department of Chemical and Biological Engineering, The University of Sheffield, Sheffield S10 2TN, UK.Department of Pharmaceutics, Rutgers University, Piscataway, NJ 08854, USA; Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ 08854, USA.Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ 08854, USA. Electronic address: rohitrr@rci.rutgers.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27633277

Citation

Meng, Wei, et al. "Statistical Analysis and Comparison of a Continuous High Shear Granulator With a Twin Screw Granulator: Effect of Process Parameters On Critical Granule Attributes and Granulation Mechanisms." International Journal of Pharmaceutics, vol. 513, no. 1-2, 2016, pp. 357-375.
Meng W, Kotamarthy L, Panikar S, et al. Statistical analysis and comparison of a continuous high shear granulator with a twin screw granulator: Effect of process parameters on critical granule attributes and granulation mechanisms. Int J Pharm. 2016;513(1-2):357-375.
Meng, W., Kotamarthy, L., Panikar, S., Sen, M., Pradhan, S., Marc, M., Litster, J. D., Muzzio, F. J., & Ramachandran, R. (2016). Statistical analysis and comparison of a continuous high shear granulator with a twin screw granulator: Effect of process parameters on critical granule attributes and granulation mechanisms. International Journal of Pharmaceutics, 513(1-2), 357-375. https://doi.org/10.1016/j.ijpharm.2016.09.041
Meng W, et al. Statistical Analysis and Comparison of a Continuous High Shear Granulator With a Twin Screw Granulator: Effect of Process Parameters On Critical Granule Attributes and Granulation Mechanisms. Int J Pharm. 2016 Nov 20;513(1-2):357-375. PubMed PMID: 27633277.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Statistical analysis and comparison of a continuous high shear granulator with a twin screw granulator: Effect of process parameters on critical granule attributes and granulation mechanisms. AU - Meng,Wei, AU - Kotamarthy,Lalith, AU - Panikar,Savitha, AU - Sen,Maitraye, AU - Pradhan,Shankali, AU - Marc,Michaelis, AU - Litster,James D, AU - Muzzio,Fernando J, AU - Ramachandran,Rohit, Y1 - 2016/09/12/ PY - 2016/05/23/received PY - 2016/08/25/revised PY - 2016/09/10/accepted PY - 2016/10/25/pubmed PY - 2017/4/22/medline PY - 2016/9/17/entrez KW - Continuous manufacturing KW - Design of experiments KW - Design space KW - Granulation mechanism KW - High shear granulation KW - Twin screw granulation SP - 357 EP - 375 JF - International journal of pharmaceutics JO - Int J Pharm VL - 513 IS - 1-2 N2 - This study is concerned with identifying the design space of two different continuous granulators and their respective granulation mechanisms. Performance of a continuous high shear granulator and a twin screw granulator with paracetamol formulations were examined by face-centered cubic design, which focused on investigating key performance metrics, namely, granule size, porosity, flowability and particle morphology of granules as a function of essential input process parameters (liquid content, throughput and rotation speed). Liquid and residence time distribution tests were also performed to gain insights into the liquid-powder mixing and flow behavior. The results indicated that continuous high shear granulation was more sensitive to process variation and produced spherical granules with monomodal size distribution and distinct internal structure and strength variation. Twin screw granulation with such a particular screw configuration showed narrower design space and granules were featured with multimodal size distribution, irregular shape, less detectible porosity difference and tighter range of strength. Granulation mechanisms explored on the basis of nucleation and growth regime maps revealed that for most cases liquid binder was uniformly distributed with fast droplet penetration into the powder bed and that granule consolidation and coalescence mainly took place in the nucleation, steady growth and rapid growth regimes. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/27633277/Statistical_analysis_and_comparison_of_a_continuous_high_shear_granulator_with_a_twin_screw_granulator:_Effect_of_process_parameters_on_critical_granule_attributes_and_granulation_mechanisms_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(16)30871-7 DB - PRIME DP - Unbound Medicine ER -