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A novel methodology to study polymodal particle size distributions produced during continuous wet granulation.
Int J Pharm. 2017 Mar 15; 519(1-2):230-239.IJ

Abstract

It is important during powder granulation to obtain particles of a homogeneous size especially in critical situations such as pharmaceutical manufacture. To date, homogeneity of particle size distribution has been defined by the use of the d50 combined with the span of the particle size distribution, which has been found ineffective for polymodal particle size distributions. This work focuses on demonstrating the limitations of the span parameter to quantify homogeneity and proposes a novel improved metric based on the transformation of a typical particle size distribution curve into a homogeneity factor which can vary from 0 to 100%. The potential of this method as a characterisation tool has been demonstrated through its application to the production of granules using two different materials. The workspace of an 11mm twin screw granulator was defined for two common excipients (α-lactose monohydrate and microcrystalline cellulose). Homogeneity of the obtained granules varied dramatically from 0 to 95% in the same workspace, allowing identification of critical process parameters (e.g. feed rate, liquid/solid ratio, torque velocities). In addition it defined the operational conditions required to produce the most homogeneous product within the range 5μm-2.2mm from both materials.

Authors+Show Affiliations

EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation (CMAC), University of Strathclyde, Technology and Innovation Centre, 99 George Street, G1 1RD Glasgow, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS), University of Strathclyde, 161 Cathedral Street, G4 0RE Glasgow, United Kingdom. Electronic address: carlota.mendez@strath.ac.uk.EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation (CMAC), University of Strathclyde, Technology and Innovation Centre, 99 George Street, G1 1RD Glasgow, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS), University of Strathclyde, 161 Cathedral Street, G4 0RE Glasgow, United Kingdom.Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS), University of Strathclyde, 161 Cathedral Street, G4 0RE Glasgow, United Kingdom; Medway School of Pharmacy, University of Kent, Medway Campus, Anson Building, Central Avenue, Chatham Maritime, Chatham, Kent, ME4 4TB, United Kingdom. Electronic address: D.Lamprou@kent.ac.uk.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28104406

Citation

Mendez Torrecillas, Carlota, et al. "A Novel Methodology to Study Polymodal Particle Size Distributions Produced During Continuous Wet Granulation." International Journal of Pharmaceutics, vol. 519, no. 1-2, 2017, pp. 230-239.
Mendez Torrecillas C, Halbert GW, Lamprou DA. A novel methodology to study polymodal particle size distributions produced during continuous wet granulation. Int J Pharm. 2017;519(1-2):230-239.
Mendez Torrecillas, C., Halbert, G. W., & Lamprou, D. A. (2017). A novel methodology to study polymodal particle size distributions produced during continuous wet granulation. International Journal of Pharmaceutics, 519(1-2), 230-239. https://doi.org/10.1016/j.ijpharm.2017.01.023
Mendez Torrecillas C, Halbert GW, Lamprou DA. A Novel Methodology to Study Polymodal Particle Size Distributions Produced During Continuous Wet Granulation. Int J Pharm. 2017 Mar 15;519(1-2):230-239. PubMed PMID: 28104406.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A novel methodology to study polymodal particle size distributions produced during continuous wet granulation. AU - Mendez Torrecillas,Carlota, AU - Halbert,Gavin W, AU - Lamprou,Dimitrios A, Y1 - 2017/01/16/ PY - 2016/11/19/received PY - 2017/01/10/revised PY - 2017/01/11/accepted PY - 2017/1/21/pubmed PY - 2017/6/18/medline PY - 2017/1/21/entrez KW - Granules KW - Homogeneity factor KW - Particle size distribution KW - Quality by design KW - Twin screw granulation SP - 230 EP - 239 JF - International journal of pharmaceutics JO - Int J Pharm VL - 519 IS - 1-2 N2 - It is important during powder granulation to obtain particles of a homogeneous size especially in critical situations such as pharmaceutical manufacture. To date, homogeneity of particle size distribution has been defined by the use of the d50 combined with the span of the particle size distribution, which has been found ineffective for polymodal particle size distributions. This work focuses on demonstrating the limitations of the span parameter to quantify homogeneity and proposes a novel improved metric based on the transformation of a typical particle size distribution curve into a homogeneity factor which can vary from 0 to 100%. The potential of this method as a characterisation tool has been demonstrated through its application to the production of granules using two different materials. The workspace of an 11mm twin screw granulator was defined for two common excipients (α-lactose monohydrate and microcrystalline cellulose). Homogeneity of the obtained granules varied dramatically from 0 to 95% in the same workspace, allowing identification of critical process parameters (e.g. feed rate, liquid/solid ratio, torque velocities). In addition it defined the operational conditions required to produce the most homogeneous product within the range 5μm-2.2mm from both materials. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/28104406/A_novel_methodology_to_study_polymodal_particle_size_distributions_produced_during_continuous_wet_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(17)30024-8 DB - PRIME DP - Unbound Medicine ER -