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Effect of Hydroxypropyl Cellulose Level on Twin-Screw Melt Granulation of Acetaminophen.
AAPS PharmSciTech. 2020 Aug 24; 21(7):240.AP

Abstract

This study investigated the effect of binder level on the physicochemical changes and tabletability of acetaminophen (APAP)-hydroxypropyl cellulose (HPC) granulated using twin-screw melt granulation. Even at 5% HPC level, the tablet tensile strength achieved up to 3.5 MPa. A minimum of 10% HPC was required for the process robustness. However, 20% HPC led to tabletability loss, attributable to the high mechanical strength of APAP granules. The over-granulated APAP granules had thick connected HPC scaffold and low porosity. Consequently, these granules were so strong that they underwent a lower degree of fracture under compression and higher elastic recovery during decompression. HPC was enriched on the surface of APAP extrudates at all HPC levels. Amorphous APAP was also observed on the extrudate surface at 20% HPC level, and it recrystallized within 24 h storage. To achieve a robust process and optimal improvement in APAP tabletability, the preferred HPC level was 10 to 15%.

Authors+Show Affiliations

Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas, 78712, USA.Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota, USA.Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas, 78712, USA.Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas, 78712, USA.Pharmaceutical Technology, Ashland Specialty Ingredients, Wilmington, Delaware, USA.Pharmaceutical Technology, Ashland Specialty Ingredients, Wilmington, Delaware, USA.Pharmaceutical Technology, Ashland Specialty Ingredients, Wilmington, Delaware, USA.Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota, USA.Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, 2409 University Avenue, A1920, Austin, Texas, 78712, USA. feng.zhang@austin.utexas.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32839891

Citation

Liu, Tongzhou, et al. "Effect of Hydroxypropyl Cellulose Level On Twin-Screw Melt Granulation of Acetaminophen." AAPS PharmSciTech, vol. 21, no. 7, 2020, p. 240.
Liu T, Paul S, Beeson BT, et al. Effect of Hydroxypropyl Cellulose Level on Twin-Screw Melt Granulation of Acetaminophen. AAPS PharmSciTech. 2020;21(7):240.
Liu, T., Paul, S., Beeson, B. T., Alexander, J., Yang, F., Bi, V., Durig, T., Sun, C. C., & Zhang, F. (2020). Effect of Hydroxypropyl Cellulose Level on Twin-Screw Melt Granulation of Acetaminophen. AAPS PharmSciTech, 21(7), 240. https://doi.org/10.1208/s12249-020-01785-y
Liu T, et al. Effect of Hydroxypropyl Cellulose Level On Twin-Screw Melt Granulation of Acetaminophen. AAPS PharmSciTech. 2020 Aug 24;21(7):240. PubMed PMID: 32839891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Hydroxypropyl Cellulose Level on Twin-Screw Melt Granulation of Acetaminophen. AU - Liu,Tongzhou, AU - Paul,Shubhajit, AU - Beeson,Brian T, AU - Alexander,Johnny, AU - Yang,Fengyuan, AU - Bi,Vivian, AU - Durig,Thomas, AU - Sun,Changquan Calvin, AU - Zhang,Feng, Y1 - 2020/08/24/ PY - 2020/05/22/received PY - 2020/08/10/accepted PY - 2020/8/26/entrez PY - 2020/8/26/pubmed PY - 2020/11/24/medline KW - Binder content KW - Granule mechanical properties KW - Granule structure KW - Over-granulation KW - Twin-screw melt granulation SP - 240 EP - 240 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 21 IS - 7 N2 - This study investigated the effect of binder level on the physicochemical changes and tabletability of acetaminophen (APAP)-hydroxypropyl cellulose (HPC) granulated using twin-screw melt granulation. Even at 5% HPC level, the tablet tensile strength achieved up to 3.5 MPa. A minimum of 10% HPC was required for the process robustness. However, 20% HPC led to tabletability loss, attributable to the high mechanical strength of APAP granules. The over-granulated APAP granules had thick connected HPC scaffold and low porosity. Consequently, these granules were so strong that they underwent a lower degree of fracture under compression and higher elastic recovery during decompression. HPC was enriched on the surface of APAP extrudates at all HPC levels. Amorphous APAP was also observed on the extrudate surface at 20% HPC level, and it recrystallized within 24 h storage. To achieve a robust process and optimal improvement in APAP tabletability, the preferred HPC level was 10 to 15%. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/32839891/Effect_of_Hydroxypropyl_Cellulose_Level_on_Twin_Screw_Melt_Granulation_of_Acetaminophen_ DB - PRIME DP - Unbound Medicine ER -