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The role of the screw profile on granular structure and mixing efficiency of a high-dose hydrophobic drug formulation during twin screw wet granulation.
Int J Pharm. 2020 Feb 15; 575:118958.IJ

Abstract

This study aimed at systematically investigating the role of distributive comb mixing element (GLC) and neutral dispersive mixing kneading block element (K90) on the structure and physical properties of granules containing high-dose of poorly water-soluble drug. Albendazole was used as the model drug at 50 wt% drug loading. Lactose monohydrate and microcrystalline cellulose were used as diluent, and 3 w/v% hydroxypropyl cellulose aqueous solution was used as binder liquid. It was found that the use of GLC element resulted in formation of granules with higher internal porosity, more homogeneous binder distribution, smaller particle size, superior compaction properties and tabletability while K90 kneading element produced relatively larger and denser granules with less homogeneous binder distribution where binder was mainly concentrated in larger granules. The use of downstream GLC element was shown to result in an approximately 8% and 57% reduction in the D50 for 0.2 and 0.3 liquid-to-solid ratios, demonstrating a significantly higher sensitivity of granule size to screw profile at higher liquid-to-solid ratios. The axial mixing efficiency was assessed by measuring the residence time distribution of the granulation process with screw profiles containing K90 and GLC elements. It was found that granules had longer mean residence time and broader residence time distribution within GLC element due to enhanced backmixing and axial dispersion processes. The continuous "fragmentation-reagglomeration" cycle was proposed to be the main advantage of distributive GLC element in granulation of hydrophobic powders.

Authors+Show Affiliations

College of Pharmacy, Department of Molecular Pharmaceutics and Drug Delivery, University of Texas at Austin, 2409 University Ave, Austin, TX 78712, United States.College of Pharmacy, Department of Pharmaceutics, University of Minnesota, 308 SE Harvard St, Minneapolis, MN 55455, United States.College of Pharmacy, Department of Pharmaceutics, University of Minnesota, 308 SE Harvard St, Minneapolis, MN 55455, United States.College of Pharmacy, Department of Molecular Pharmaceutics and Drug Delivery, University of Texas at Austin, 2409 University Ave, Austin, TX 78712, United States. Electronic address: feng.zhang@austin.utexas.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31846725

Citation

Kashani Rahimi, Shahab, et al. "The Role of the Screw Profile On Granular Structure and Mixing Efficiency of a High-dose Hydrophobic Drug Formulation During Twin Screw Wet Granulation." International Journal of Pharmaceutics, vol. 575, 2020, p. 118958.
Kashani Rahimi S, Paul S, Sun CC, et al. The role of the screw profile on granular structure and mixing efficiency of a high-dose hydrophobic drug formulation during twin screw wet granulation. Int J Pharm. 2020;575:118958.
Kashani Rahimi, S., Paul, S., Sun, C. C., & Zhang, F. (2020). The role of the screw profile on granular structure and mixing efficiency of a high-dose hydrophobic drug formulation during twin screw wet granulation. International Journal of Pharmaceutics, 575, 118958. https://doi.org/10.1016/j.ijpharm.2019.118958
Kashani Rahimi S, et al. The Role of the Screw Profile On Granular Structure and Mixing Efficiency of a High-dose Hydrophobic Drug Formulation During Twin Screw Wet Granulation. Int J Pharm. 2020 Feb 15;575:118958. PubMed PMID: 31846725.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The role of the screw profile on granular structure and mixing efficiency of a high-dose hydrophobic drug formulation during twin screw wet granulation. AU - Kashani Rahimi,Shahab, AU - Paul,Shubhajit, AU - Sun,Changquan Calvin, AU - Zhang,Feng, Y1 - 2019/12/14/ PY - 2019/10/08/received PY - 2019/12/10/revised PY - 2019/12/12/accepted PY - 2019/12/18/pubmed PY - 2020/11/25/medline PY - 2019/12/18/entrez KW - Granulation residence time KW - Hydrophobic powder KW - Kneading element KW - Screw design KW - Screw profile KW - Twin screw wet granulation SP - 118958 EP - 118958 JF - International journal of pharmaceutics JO - Int J Pharm VL - 575 N2 - This study aimed at systematically investigating the role of distributive comb mixing element (GLC) and neutral dispersive mixing kneading block element (K90) on the structure and physical properties of granules containing high-dose of poorly water-soluble drug. Albendazole was used as the model drug at 50 wt% drug loading. Lactose monohydrate and microcrystalline cellulose were used as diluent, and 3 w/v% hydroxypropyl cellulose aqueous solution was used as binder liquid. It was found that the use of GLC element resulted in formation of granules with higher internal porosity, more homogeneous binder distribution, smaller particle size, superior compaction properties and tabletability while K90 kneading element produced relatively larger and denser granules with less homogeneous binder distribution where binder was mainly concentrated in larger granules. The use of downstream GLC element was shown to result in an approximately 8% and 57% reduction in the D50 for 0.2 and 0.3 liquid-to-solid ratios, demonstrating a significantly higher sensitivity of granule size to screw profile at higher liquid-to-solid ratios. The axial mixing efficiency was assessed by measuring the residence time distribution of the granulation process with screw profiles containing K90 and GLC elements. It was found that granules had longer mean residence time and broader residence time distribution within GLC element due to enhanced backmixing and axial dispersion processes. The continuous "fragmentation-reagglomeration" cycle was proposed to be the main advantage of distributive GLC element in granulation of hydrophobic powders. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/31846725/The_role_of_the_screw_profile_on_granular_structure_and_mixing_efficiency_of_a_high_dose_hydrophobic_drug_formulation_during_twin_screw_wet_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(19)31003-8 DB - PRIME DP - Unbound Medicine ER -