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The use of rheology combined with differential scanning calorimetry to elucidate the granulation mechanism of an immiscible formulation during continuous twin-screw melt granulation

(2016) PHARMACEUTICAL RESEARCH. 33(10). p.2481-2494
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Abstract
Twin screw hot melt granulation (TS HMG) is a valuable, but still unexplored alternative to continuous granulation of moisture sensitive drugs. However, knowledge of the material behavior during TS HMG is crucial to optimize the formulation, process and resulting granule properties. The aim of this study was to evaluate the agglomeration mechanism during TS HMG using a rheometer in combination with differential scanning calorimetry (DSC). An immiscible drug-binder formulation (caffeine-Soluplus(A (R))) was granulated via TS HMG in combination with thermal and rheological analysis (conventional and Rheoscope), granule characterization and Near Infrared chemical imaging (NIR-CI). A thin binder layer with restricted mobility was formed on the surface of the drug particles during granulation and is covered by a second layer with improved mobility when the Soluplus(A (R)) concentration exceeded 15% (w/w). The formation of this second layer was facilitated at elevated granulation temperatures and resulted in smaller and more spherical granules. The combination of thermal and rheological analysis and NIR-CI images was advantageous to develop in-depth understanding of the agglomeration mechanism during continuous TS HMG and provided insight in the granule properties as function of process temperature and binder concentration.
Keywords
agglomeration mechanism, caffeine anhydrous, glass transition temperature, granule properties, soluplus (R), tan(delta), HIGH-SHEAR MIXER, GLASS-TRANSITION BEHAVIOR, POWDER PARTICLE-SIZE, WET GRANULATION, BINDER VISCOSITY, NANOCOMPOSITES, EXTRUDER, GROWTH, AGGLOMERATION, DISPERSIONS

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Chicago
Monteyne, Tinne, Liza Heeze, Séverine Mortier, Klaus Oldörp, Ruth Cardinaels, Ingmar Nopens, Chris Vervaet, Jean Paul Remon, and Thomas De Beer. 2016. “The Use of Rheology Combined with Differential Scanning Calorimetry to Elucidate the Granulation Mechanism of an Immiscible Formulation During Continuous Twin-screw Melt Granulation.” Pharmaceutical Research 33 (10): 2481–2494.
APA
Monteyne, Tinne, Heeze, L., Mortier, S., Oldörp, K., Cardinaels, R., Nopens, I., Vervaet, C., et al. (2016). The use of rheology combined with differential scanning calorimetry to elucidate the granulation mechanism of an immiscible formulation during continuous twin-screw melt granulation. PHARMACEUTICAL RESEARCH, 33(10), 2481–2494.
Vancouver
1.
Monteyne T, Heeze L, Mortier S, Oldörp K, Cardinaels R, Nopens I, et al. The use of rheology combined with differential scanning calorimetry to elucidate the granulation mechanism of an immiscible formulation during continuous twin-screw melt granulation. PHARMACEUTICAL RESEARCH. 2016;33(10):2481–94.
MLA
Monteyne, Tinne, Liza Heeze, Séverine Mortier, et al. “The Use of Rheology Combined with Differential Scanning Calorimetry to Elucidate the Granulation Mechanism of an Immiscible Formulation During Continuous Twin-screw Melt Granulation.” PHARMACEUTICAL RESEARCH 33.10 (2016): 2481–2494. Print.
@article{8500555,
  abstract     = {Twin screw hot melt granulation (TS HMG) is a valuable, but still unexplored alternative to continuous granulation of moisture sensitive drugs. However, knowledge of the material behavior during TS HMG is crucial to optimize the formulation, process and resulting granule properties. The aim of this study was to evaluate the agglomeration mechanism during TS HMG using a rheometer in combination with differential scanning calorimetry (DSC). 
An immiscible drug-binder formulation (caffeine-Soluplus(A (R))) was granulated via TS HMG in combination with thermal and rheological analysis (conventional and Rheoscope), granule characterization and Near Infrared chemical imaging (NIR-CI). 
A thin binder layer with restricted mobility was formed on the surface of the drug particles during granulation and is covered by a second layer with improved mobility when the Soluplus(A (R)) concentration exceeded 15\% (w/w). The formation of this second layer was facilitated at elevated granulation temperatures and resulted in smaller and more spherical granules. 
The combination of thermal and rheological analysis and NIR-CI images was advantageous to develop in-depth understanding of the agglomeration mechanism during continuous TS HMG and provided insight in the granule properties as function of process temperature and binder concentration.},
  author       = {Monteyne, Tinne and Heeze, Liza and Mortier, S{\'e}verine and Old{\"o}rp, Klaus and Cardinaels, Ruth and Nopens, Ingmar and Vervaet, Chris and Remon, Jean Paul and De Beer, Thomas},
  issn         = {0724-8741},
  journal      = {PHARMACEUTICAL RESEARCH},
  language     = {eng},
  number       = {10},
  pages        = {2481--2494},
  title        = {The use of rheology combined with differential scanning calorimetry to elucidate the granulation mechanism of an immiscible formulation during continuous twin-screw melt granulation},
  url          = {http://dx.doi.org/10.1007/s11095-016-1973-6},
  volume       = {33},
  year         = {2016},
}

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