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Process optimization for continuous extrusion wet granulation.
Pharm Dev Technol. 2011 Aug; 16(4):302-15.PD

Abstract

Three granulating binders in high drug-load acetaminophen blends were evaluated using high shear granulation and extrusion granulation. A polymethacrylate binder enhanced tablet tensile strength with rapid disintegration in simulated gastric fluid, whereas polyvinylpyrrolidone and hydroxypropyl cellulose binders produced less desirable tablets. Using the polymethacrylate binder, the extrusion granulation process was studied regarding the effects of granulating liquid, injection rate and screw speed on granule properties. A full factorial experimental design was conducted to allow the statistical analysis of interactions between extrusion process parameters. Response variables considered in the study included extruder power consumption (screw loading), granule bulk/tapped density, particle size distribution, tablet hardness, friability, disintegration time and dissolution.

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Authors+Show Affiliations

Tan L
Pfizer Global R&D, Groton Laboratories, Groton, CT 06340, USA.
Carella AJ
No affiliation info available
Ren Y
No affiliation info available
Lo JB
No affiliation info available

MeSH

AcetaminophenAnalysis of VarianceCelluloseDrug CompoundingExcipientsParticle SizePolymethacrylic AcidsPovidonePowdersShear StrengthSolubilityTabletsTensile Strength

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

20367553

Citation

Tan, Li, et al. "Process Optimization for Continuous Extrusion Wet Granulation." Pharmaceutical Development and Technology, vol. 16, no. 4, 2011, pp. 302-15.
Tan L, Carella AJ, Ren Y, et al. Process optimization for continuous extrusion wet granulation. Pharm Dev Technol. 2011;16(4):302-15.
Tan, L., Carella, A. J., Ren, Y., & Lo, J. B. (2011). Process optimization for continuous extrusion wet granulation. Pharmaceutical Development and Technology, 16(4), 302-15. https://doi.org/10.3109/10837451003692587
Tan L, et al. Process Optimization for Continuous Extrusion Wet Granulation. Pharm Dev Technol. 2011;16(4):302-15. PubMed PMID: 20367553.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Process optimization for continuous extrusion wet granulation. AU - Tan,Li, AU - Carella,Anthony J, AU - Ren,Yukun, AU - Lo,Julian B, Y1 - 2010/04/06/ PY - 2010/4/7/entrez PY - 2010/4/7/pubmed PY - 2012/2/11/medline SP - 302 EP - 15 JF - Pharmaceutical development and technology JO - Pharm Dev Technol VL - 16 IS - 4 N2 - Three granulating binders in high drug-load acetaminophen blends were evaluated using high shear granulation and extrusion granulation. A polymethacrylate binder enhanced tablet tensile strength with rapid disintegration in simulated gastric fluid, whereas polyvinylpyrrolidone and hydroxypropyl cellulose binders produced less desirable tablets. Using the polymethacrylate binder, the extrusion granulation process was studied regarding the effects of granulating liquid, injection rate and screw speed on granule properties. A full factorial experimental design was conducted to allow the statistical analysis of interactions between extrusion process parameters. Response variables considered in the study included extruder power consumption (screw loading), granule bulk/tapped density, particle size distribution, tablet hardness, friability, disintegration time and dissolution. SN - 1097-9867 UR - https://www.unboundmedicine.com/medline/citation/20367553/Process_optimization_for_continuous_extrusion_wet_granulation_ L2 - https://www.tandfonline.com/doi/full/10.3109/10837451003692587 DB - PRIME DP - Unbound Medicine ER -