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Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach.
Int J Pharm. 2020 Apr 15; 579:119139.IJ

Abstract

This study aimed to transfer a high shear granulation (HSG) process to a twin-screw granulation (TSG) process while maintaining equivalent dissolution profiles. Ibuprofen (IBP) was used as poorly soluble model drug. Granules were obtained by HSG or TSG according to a full factorial design. The liquid-to-solid ratio and wet massing time (HSG) or powder throughput (TSG) were selected as factors. The granules were compressed to tablets with immediate release and a drug load of 50% (w/w). Quality attributes (QAs) of the granules, especially the granule strength (GS), and the resulting tablets were evaluated. The effect of process parameters on the QAs was statistically analyzed. The comparison of HSG tablets with TSG tablets revealed that TSG tablets showed higher tensile strength and lower ejection force than HSG tablets. The dissolution profiles of the tablets in different pH media were also evaluated. Equivalent dissolution profiles in all four media (e.g., f2 values ≥ 54 in pH5.5) were obtained by adjusting process parameters. It was concluded that the GS was the most important QA for dissolution.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Miyazaki Y
Heinrich Heine University, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstr. 1, 40225 Duesseldorf, Germany; ONO Pharmaceutical Co., Ltd., CMC & Production HQs, Pharmaceutical Product Development & Management, Pharmaceutical Product Development, Non-Sterile Product, 15-26 Kamiji 1-Chome Higashinari-ku, 537-0003 Osaka, Japan.
Lenhart V
Heinrich Heine University, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstr. 1, 40225 Duesseldorf, Germany.
Kleinebudde P
Heinrich Heine University, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstr. 1, 40225 Duesseldorf, Germany. Electronic address: kleinebudde@hhu.de.

MeSH

Chemistry, PharmaceuticalDrug CompoundingDrug LiberationExcipientsHydrogen-Ion ConcentrationIbuprofenParticle SizePorosityPowdersPressureShear StrengthSolubilitySurface PropertiesTabletsTemperature

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32061724

Citation

Miyazaki, Yuta, et al. "Switch of Tablet Manufacturing From High Shear Granulation to Twin-screw Granulation Using Quality By Design Approach." International Journal of Pharmaceutics, vol. 579, 2020, p. 119139.
Miyazaki Y, Lenhart V, Kleinebudde P. Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach. Int J Pharm. 2020;579:119139.
Miyazaki, Y., Lenhart, V., & Kleinebudde, P. (2020). Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach. International Journal of Pharmaceutics, 579, 119139. https://doi.org/10.1016/j.ijpharm.2020.119139
Miyazaki Y, Lenhart V, Kleinebudde P. Switch of Tablet Manufacturing From High Shear Granulation to Twin-screw Granulation Using Quality By Design Approach. Int J Pharm. 2020 Apr 15;579:119139. PubMed PMID: 32061724.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Switch of tablet manufacturing from high shear granulation to twin-screw granulation using quality by design approach. AU - Miyazaki,Yuta, AU - Lenhart,Vincent, AU - Kleinebudde,Peter, Y1 - 2020/02/13/ PY - 2019/10/30/received PY - 2020/02/10/revised PY - 2020/02/11/accepted PY - 2020/2/18/pubmed PY - 2020/12/29/medline PY - 2020/2/17/entrez KW - Equivalent dissolution profile KW - Granule strength KW - High shear granulation KW - Twin-screw granulation SP - 119139 EP - 119139 JF - International journal of pharmaceutics JO - Int J Pharm VL - 579 N2 - This study aimed to transfer a high shear granulation (HSG) process to a twin-screw granulation (TSG) process while maintaining equivalent dissolution profiles. Ibuprofen (IBP) was used as poorly soluble model drug. Granules were obtained by HSG or TSG according to a full factorial design. The liquid-to-solid ratio and wet massing time (HSG) or powder throughput (TSG) were selected as factors. The granules were compressed to tablets with immediate release and a drug load of 50% (w/w). Quality attributes (QAs) of the granules, especially the granule strength (GS), and the resulting tablets were evaluated. The effect of process parameters on the QAs was statistically analyzed. The comparison of HSG tablets with TSG tablets revealed that TSG tablets showed higher tensile strength and lower ejection force than HSG tablets. The dissolution profiles of the tablets in different pH media were also evaluated. Equivalent dissolution profiles in all four media (e.g., f2 values ≥ 54 in pH5.5) were obtained by adjusting process parameters. It was concluded that the GS was the most important QA for dissolution. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/32061724/Switch_of_tablet_manufacturing_from_high_shear_granulation_to_twin_screw_granulation_using_quality_by_design_approach_ DB - PRIME DP - Unbound Medicine ER -