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Fluid bed granulation of a poorly water soluble, low density, micronized drug: comparison with high shear granulation.
Int J Pharm. 2002 Apr 26; 237(1-2):1-14.IJ

Abstract

A 2(4-1) fractional factorial design was used to evaluate the effect of various process variables in fluid bed granulation, on the physico-chemical properties of granule and tablet containing a high dose, poorly water soluble, low density, and micronized drug. The process variables studied were inlet air temperature, inlet air flow, spray rate of the binder solution, and atomization air pressure. Tablets with identical composition, weight, size and hardness were also manufactured in a high shear granulator and their physical properties were determined and compared with those produced by the fluidized bed granulation method. Except for the granule size distribution, other physical properties of granulations and tablets produced in a fluid bed granulator are independent of the selected process variables within the study range. Both atomization air pressure and spray rate of the binder solution had strong impact on granule size distribution. Irrespective of the process conditions used in the fluid bed granulation, granules from this process were more porous, less dense and more compressible than the granules from the high shear granulation process. Comparable tablet dissolution rates to those prepared by the optimized high shear granulation method can be achieved by selecting the appropriate process conditions in fluid bed granulation. These results suggest that wet granulation tablets of a high dose, poorly water soluble, low density, micronized drug can be manufactured using a fluidized bed granulation method, with comparable tablet dissolution rates to those produced with an optimized high shear granulation method.

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Authors+Show Affiliations

Gao JZ
Pharmaceutics Research and Development, Bristol-Myers Squibb Company, Experimental Station, P.O. Box 80400, Wilmington, DE 19880-0400, USA. j.z.gao@dupontpharma.com
Jain A
No affiliation info available
Motheram R
No affiliation info available
Gray DB
No affiliation info available
Hussain MA
No affiliation info available

MeSH

PowdersSolubilityStress, MechanicalTabletsTechnology, PharmaceuticalWater

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

11955799

Citation

Gao, Julia Z H., et al. "Fluid Bed Granulation of a Poorly Water Soluble, Low Density, Micronized Drug: Comparison With High Shear Granulation." International Journal of Pharmaceutics, vol. 237, no. 1-2, 2002, pp. 1-14.
Gao JZ, Jain A, Motheram R, et al. Fluid bed granulation of a poorly water soluble, low density, micronized drug: comparison with high shear granulation. Int J Pharm. 2002;237(1-2):1-14.
Gao, J. Z., Jain, A., Motheram, R., Gray, D. B., & Hussain, M. A. (2002). Fluid bed granulation of a poorly water soluble, low density, micronized drug: comparison with high shear granulation. International Journal of Pharmaceutics, 237(1-2), 1-14.
Gao JZ, et al. Fluid Bed Granulation of a Poorly Water Soluble, Low Density, Micronized Drug: Comparison With High Shear Granulation. Int J Pharm. 2002 Apr 26;237(1-2):1-14. PubMed PMID: 11955799.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fluid bed granulation of a poorly water soluble, low density, micronized drug: comparison with high shear granulation. AU - Gao,Julia Z H, AU - Jain,A, AU - Motheram,R, AU - Gray,D B, AU - Hussain,M A, PY - 2002/4/17/pubmed PY - 2002/7/3/medline PY - 2002/4/17/entrez SP - 1 EP - 14 JF - International journal of pharmaceutics JO - Int J Pharm VL - 237 IS - 1-2 N2 - A 2(4-1) fractional factorial design was used to evaluate the effect of various process variables in fluid bed granulation, on the physico-chemical properties of granule and tablet containing a high dose, poorly water soluble, low density, and micronized drug. The process variables studied were inlet air temperature, inlet air flow, spray rate of the binder solution, and atomization air pressure. Tablets with identical composition, weight, size and hardness were also manufactured in a high shear granulator and their physical properties were determined and compared with those produced by the fluidized bed granulation method. Except for the granule size distribution, other physical properties of granulations and tablets produced in a fluid bed granulator are independent of the selected process variables within the study range. Both atomization air pressure and spray rate of the binder solution had strong impact on granule size distribution. Irrespective of the process conditions used in the fluid bed granulation, granules from this process were more porous, less dense and more compressible than the granules from the high shear granulation process. Comparable tablet dissolution rates to those prepared by the optimized high shear granulation method can be achieved by selecting the appropriate process conditions in fluid bed granulation. These results suggest that wet granulation tablets of a high dose, poorly water soluble, low density, micronized drug can be manufactured using a fluidized bed granulation method, with comparable tablet dissolution rates to those produced with an optimized high shear granulation method. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/11955799/Fluid_bed_granulation_of_a_poorly_water_soluble_low_density_micronized_drug:_comparison_with_high_shear_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378517301009826 DB - PRIME DP - Unbound Medicine ER -