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Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation.
Int J Pharm. 2020 Dec 15; 591:119941.IJ

Abstract

Melt granules of DI-CAFOS® A12 and 15% (w/w) Kolliphor® P407 were manufactured in a twin-screw granulator (TSG) at five different conditions (screw speed and throughput varied) and compared to granules manufactured in a high-shear granulator (HSG) (rotation speed of chopper/impeller and granulation time varied). Evaluated granules characteristics were process yield, particle-size distribution (PSD), particle morphology, flowability, porosity, specific surface area (SSA), tabletability, compressibility and binder distribution. Compared to TSG, granules produced from HSG were more spherical in shape with lower porosity, smaller mean particle size and a superior flowability. Granules made by TSG showed a more elongated structure, higher porosity and larger mean particle size with smaller SSA instead. Concerning the compression process of granules, tablets made of TSG granules exhibited a higher tabletability compared to HSG granules, whereas the compressibility remained similar. In the case of the TSG granules, energy-dispersive-X-ray (EDX) measurements of the tablet surface indicated an enhanced homogenous binder distribution. Additionally, the EDX-analyses determined that more binder was available between the individual particles, resulting in a stronger bonding.

Authors+Show Affiliations

Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany.Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany.Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany.Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany.Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany. Electronic address: kgwagner@uni-bonn.de.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33065223

Citation

Steffens, Kristina E., et al. "Melt Granulation: a Comparison of Granules Produced Via High-shear Mixing and Twin-screw Granulation." International Journal of Pharmaceutics, vol. 591, 2020, p. 119941.
Steffens KE, Brenner MB, Hartig MU, et al. Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation. Int J Pharm. 2020;591:119941.
Steffens, K. E., Brenner, M. B., Hartig, M. U., Monschke, M., & Wagner, K. G. (2020). Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation. International Journal of Pharmaceutics, 591, 119941. https://doi.org/10.1016/j.ijpharm.2020.119941
Steffens KE, et al. Melt Granulation: a Comparison of Granules Produced Via High-shear Mixing and Twin-screw Granulation. Int J Pharm. 2020 Dec 15;591:119941. PubMed PMID: 33065223.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation. AU - Steffens,Kristina E, AU - Brenner,Marvin B, AU - Hartig,Michael U, AU - Monschke,Marius, AU - Wagner,Karl G, Y1 - 2020/10/14/ PY - 2020/03/22/received PY - 2020/09/25/revised PY - 2020/09/28/accepted PY - 2020/10/17/pubmed PY - 2020/10/17/medline PY - 2020/10/16/entrez KW - Binder distribution KW - Flowability KW - High-shear mixer KW - Melt granulation KW - Porosity KW - Tabletability KW - Twin-screw granulator SP - 119941 EP - 119941 JF - International journal of pharmaceutics JO - Int J Pharm VL - 591 N2 - Melt granules of DI-CAFOS® A12 and 15% (w/w) Kolliphor® P407 were manufactured in a twin-screw granulator (TSG) at five different conditions (screw speed and throughput varied) and compared to granules manufactured in a high-shear granulator (HSG) (rotation speed of chopper/impeller and granulation time varied). Evaluated granules characteristics were process yield, particle-size distribution (PSD), particle morphology, flowability, porosity, specific surface area (SSA), tabletability, compressibility and binder distribution. Compared to TSG, granules produced from HSG were more spherical in shape with lower porosity, smaller mean particle size and a superior flowability. Granules made by TSG showed a more elongated structure, higher porosity and larger mean particle size with smaller SSA instead. Concerning the compression process of granules, tablets made of TSG granules exhibited a higher tabletability compared to HSG granules, whereas the compressibility remained similar. In the case of the TSG granules, energy-dispersive-X-ray (EDX) measurements of the tablet surface indicated an enhanced homogenous binder distribution. Additionally, the EDX-analyses determined that more binder was available between the individual particles, resulting in a stronger bonding. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/33065223/Melt_granulation:_A_comparison_of_granules_produced_via_high_shear_mixing_and_twin_screw_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(20)30926-1 DB - PRIME DP - Unbound Medicine ER -