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How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation?
Eur J Pharm Sci. 2021 Feb 01; 157:105645.EJ

Abstract

Using a model formulation of 80% gabapentin and 20% hydroxypropyl cellulose (KlucelTM), we investigate how differences in the geometry of mixing elements in the Leistritz Nano-16 and Micro-18 extruders affect granulation mechanisms and the properties of the resulting granules. Two extruders, Leistritz Nano-16 and Micro-18, commonly used in development and manufacturing, respectively, were used. The kneading blocks of the Nano-16 extruder are less efficient in dispersive mixing than the kneading blocks of the Micro-18 due to the thinner discs (2.5 mm wide) of the Nano-16. Therefore, our model formulation could be granulated only under a higher degree of fill (DF) by enhancing the axial compaction and heating of the barrel. In contrast, the thicker (5 mm wide) kneading blocks of the Micro-18 extruder provide efficient dispersive mixing that enables granulation without axial compaction and barrel heating. The higher specific mechanical energy (SME) achieved at higher screw speeds and lower feed rates led to more granulation. Because of the difference in granulation mechanisms between the two extruders, critical processing parameters also differed. Tabletability and degradant content of granules correlated positively with DF for the Nano-16 but with SME for the Micro-18 extruder.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Kittikunakorn N
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, the University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas 78712, USA.
Paul S
Department of Pharmaceutics, University of Minnesota, 308 SE Harvard St, Minneapolis, MN 55455, USA.
Koleng JJ
Division of Chemical Engineering, School of Engineering, the University of Texas at Austin, 200 E Dean Keeton St, Austin, TX 78712, USA.
Liu T
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, the University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas 78712, USA.
Cook R
Department of Materials Science and Engineering, Missouri University of Science and Technology, Rolla, MO 65409, USA.
Yang F
Pharmaceutical Technology, Ashland Specialty Ingredients, Wilmington, DE.
Bi V
Pharmaceutical Technology, Ashland Specialty Ingredients, Wilmington, DE.
Durig T
Pharmaceutical Technology, Ashland Specialty Ingredients, Wilmington, DE.
Sun CC
Department of Pharmaceutics, University of Minnesota, 308 SE Harvard St, Minneapolis, MN 55455, USA.
Kumar A
Department of Materials Science and Engineering, Missouri University of Science and Technology, Rolla, MO 65409, USA.
Zhang F
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, the University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas 78712, USA. Electronic address: feng.zhang@austin.utexas.edu.

MeSH

Drug CompoundingFreezingGabapentinParticle SizeTechnology, Pharmaceutical

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33207275

Citation

Kittikunakorn, Nada, et al. "How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation?" European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 157, 2021, p. 105645.
Kittikunakorn N, Paul S, Koleng JJ, et al. How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation? Eur J Pharm Sci. 2021;157:105645.
Kittikunakorn, N., Paul, S., Koleng, J. J., Liu, T., Cook, R., Yang, F., Bi, V., Durig, T., Sun, C. C., Kumar, A., & Zhang, F. (2021). How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation? European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 157, 105645. https://doi.org/10.1016/j.ejps.2020.105645
Kittikunakorn N, et al. How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation. Eur J Pharm Sci. 2021 Feb 1;157:105645. PubMed PMID: 33207275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - How Does the Dissimilarity of Screw Geometry Impact Twin-screw Melt Granulation? AU - Kittikunakorn,Nada, AU - Paul,Shubhajit, AU - Koleng,John J,3rd AU - Liu,Tongzhou, AU - Cook,Rachel, AU - Yang,Fengyuan, AU - Bi,Vivian, AU - Durig,Thomas, AU - Sun,Changquan Calvin, AU - Kumar,Aditya, AU - Zhang,Feng, Y1 - 2020/11/15/ PY - 2020/06/17/received PY - 2020/10/19/revised PY - 2020/11/10/accepted PY - 2020/11/19/pubmed PY - 2021/6/22/medline PY - 2020/11/18/entrez SP - 105645 EP - 105645 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 157 N2 - Using a model formulation of 80% gabapentin and 20% hydroxypropyl cellulose (KlucelTM), we investigate how differences in the geometry of mixing elements in the Leistritz Nano-16 and Micro-18 extruders affect granulation mechanisms and the properties of the resulting granules. Two extruders, Leistritz Nano-16 and Micro-18, commonly used in development and manufacturing, respectively, were used. The kneading blocks of the Nano-16 extruder are less efficient in dispersive mixing than the kneading blocks of the Micro-18 due to the thinner discs (2.5 mm wide) of the Nano-16. Therefore, our model formulation could be granulated only under a higher degree of fill (DF) by enhancing the axial compaction and heating of the barrel. In contrast, the thicker (5 mm wide) kneading blocks of the Micro-18 extruder provide efficient dispersive mixing that enables granulation without axial compaction and barrel heating. The higher specific mechanical energy (SME) achieved at higher screw speeds and lower feed rates led to more granulation. Because of the difference in granulation mechanisms between the two extruders, critical processing parameters also differed. Tabletability and degradant content of granules correlated positively with DF for the Nano-16 but with SME for the Micro-18 extruder. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/33207275/How_Does_the_Dissimilarity_of_Screw_Geometry_Impact_Twin_screw_Melt_Granulation DB - PRIME DP - Unbound Medicine ER -