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Granule size distributions after twin-screw granulation - Do not forget the feeding systems.
Eur J Pharm Biopharm. 2016 Sep; 106:59-69.EJ

Abstract

The aim of this study was to investigate the influence of qualitatively different powder feeder performances on resulting granule size distributions after twin-screw granulation of a highly drug loaded, hydrophobic mixture and a mannitol powder. It was shown that powder feeder related problems usually cannot be identified by trusting in the values given by the feeder. Therefore, a newly developed model for the evaluation of the performance of powder feeders was introduced and it was tried to connect this model to residence time distributions in twin-screw granulation processes. The influence of feeder performances on resulting granule size distributions varied, depending on the applied screw configuration and the used powder. Regarding the hydrophobic and highly drug loaded formulation, which was granulated at an L/S-ratio of 0.5, a pure conveying screw and a medium kneading configuration, consisting of 60° kneading blocks were negatively influenced by poor feeder settings. For optimal settings more narrow distributions could be obtained. For an extensive kneading configuration good and poor settings resulted in mono-modal granule size distributions but were differing in the overall size. Mannitol, a model substance for a liquid sensitive formulation was granulated at an L/S-ratio of 0.075. It was even more important to maintain optimal feeding as mannitol was highly affected by poor feeder performances. Even an extensive kneading configuration could not level the errors in powder feeder performance, resulting in qualitatively different granule size distributions. The results of this study demonstrate the importance of detailed knowledge about applied feeding systems to gain optimal performance in twin-screw granulation.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Meier R
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany.
Thommes M
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany; Faculty of Bio- and Chemical Engineering, Technical University Dortmund, Emil-Figge-Str. 68, 44227 Dortmund, Germany.
Rasenack N
Novartis AG, 4002 Basel, Switzerland.
Moll KP
Novartis AG, 4002 Basel, Switzerland.
Krumme M
Novartis AG, 4002 Basel, Switzerland.
Kleinebudde P
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany. Electronic address: Kleinebudde@hhu.de.

MeSH

Chemistry, PharmaceuticalParticle SizePowders

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27224854

Citation

Meier, R, et al. "Granule Size Distributions After Twin-screw Granulation - Do Not Forget the Feeding Systems." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 106, 2016, pp. 59-69.
Meier R, Thommes M, Rasenack N, et al. Granule size distributions after twin-screw granulation - Do not forget the feeding systems. Eur J Pharm Biopharm. 2016;106:59-69.
Meier, R., Thommes, M., Rasenack, N., Moll, K. P., Krumme, M., & Kleinebudde, P. (2016). Granule size distributions after twin-screw granulation - Do not forget the feeding systems. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 106, 59-69. https://doi.org/10.1016/j.ejpb.2016.05.011
Meier R, et al. Granule Size Distributions After Twin-screw Granulation - Do Not Forget the Feeding Systems. Eur J Pharm Biopharm. 2016;106:59-69. PubMed PMID: 27224854.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Granule size distributions after twin-screw granulation - Do not forget the feeding systems. AU - Meier,R, AU - Thommes,M, AU - Rasenack,N, AU - Moll,K-P, AU - Krumme,M, AU - Kleinebudde,P, Y1 - 2016/05/17/ PY - 2015/10/01/received PY - 2016/05/13/revised PY - 2016/05/15/accepted PY - 2016/5/26/entrez PY - 2016/5/26/pubmed PY - 2017/2/28/medline KW - Continuous granulation KW - Granule size distributions KW - Powder feeder evaluation KW - Residence time KW - Twin-screw granulation SP - 59 EP - 69 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 106 N2 - The aim of this study was to investigate the influence of qualitatively different powder feeder performances on resulting granule size distributions after twin-screw granulation of a highly drug loaded, hydrophobic mixture and a mannitol powder. It was shown that powder feeder related problems usually cannot be identified by trusting in the values given by the feeder. Therefore, a newly developed model for the evaluation of the performance of powder feeders was introduced and it was tried to connect this model to residence time distributions in twin-screw granulation processes. The influence of feeder performances on resulting granule size distributions varied, depending on the applied screw configuration and the used powder. Regarding the hydrophobic and highly drug loaded formulation, which was granulated at an L/S-ratio of 0.5, a pure conveying screw and a medium kneading configuration, consisting of 60° kneading blocks were negatively influenced by poor feeder settings. For optimal settings more narrow distributions could be obtained. For an extensive kneading configuration good and poor settings resulted in mono-modal granule size distributions but were differing in the overall size. Mannitol, a model substance for a liquid sensitive formulation was granulated at an L/S-ratio of 0.075. It was even more important to maintain optimal feeding as mannitol was highly affected by poor feeder performances. Even an extensive kneading configuration could not level the errors in powder feeder performance, resulting in qualitatively different granule size distributions. The results of this study demonstrate the importance of detailed knowledge about applied feeding systems to gain optimal performance in twin-screw granulation. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/27224854/Granule_size_distributions_after_twin_screw_granulation___Do_not_forget_the_feeding_systems_ DB - PRIME DP - Unbound Medicine ER -