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Development and optimization of solid dispersion containing pellets of itraconazole prepared by high shear pelletization.
Int J Pharm. 2007 Jun 07; 337(1-2):80-7.IJ

Abstract

This study investigated the solid dispersion containing pellets of itraconazole for enhanced drug dissolution rate. The influence of process parameters used during high shear pelletization on the pellet properties including pellet size and dissolution rate was also studied. Solid dispersions of itraconazole were prepared with Eudragit E100, a hydrophilic polymer, by a simple fusion method followed by powdered and characterized by differential scanning calorimetry and X-ray powder diffraction. Solid dispersions containing pellets were consequently prepared using a lab-scale high shear mixer. In order to improve the product quality, a central composite design was applied to optimize the critical process variables, such as impeller speed and kneading time, and the results were modeled statistically. Itraconazole was presented as an amorphous state in the solid dispersion prepared at a drug to polymer ratio of 1:2. Both studied parameters had great effect on the responses. Powdered solid dispersion and pellets prepared using the optimal parameter settings showed approximately 30- and 70-fold increases in dissolution rate over the pure drug, respectively. Solid dispersion prepared by simple fusion method could be an option for itraconazole solubility enhancement. Pelletization process in high shear mixer can be optimized effectively by central composite design.

Authors+Show Affiliations

Department of Pharmaceutics, Shenyang Pharmaceutical University, No. 103 Wenhua Road, Shenyang 110016, PR China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17241757

Citation

Ye, Guanhao, et al. "Development and Optimization of Solid Dispersion Containing Pellets of Itraconazole Prepared By High Shear Pelletization." International Journal of Pharmaceutics, vol. 337, no. 1-2, 2007, pp. 80-7.
Ye G, Wang S, Heng PW, et al. Development and optimization of solid dispersion containing pellets of itraconazole prepared by high shear pelletization. Int J Pharm. 2007;337(1-2):80-7.
Ye, G., Wang, S., Heng, P. W., Chen, L., & Wang, C. (2007). Development and optimization of solid dispersion containing pellets of itraconazole prepared by high shear pelletization. International Journal of Pharmaceutics, 337(1-2), 80-7.
Ye G, et al. Development and Optimization of Solid Dispersion Containing Pellets of Itraconazole Prepared By High Shear Pelletization. Int J Pharm. 2007 Jun 7;337(1-2):80-7. PubMed PMID: 17241757.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and optimization of solid dispersion containing pellets of itraconazole prepared by high shear pelletization. AU - Ye,Guanhao, AU - Wang,Siling, AU - Heng,Paul Wan Sia, AU - Chen,Ling, AU - Wang,Chao, Y1 - 2006/12/27/ PY - 2006/09/13/received PY - 2006/11/22/revised PY - 2006/12/20/accepted PY - 2007/1/24/pubmed PY - 2007/8/3/medline PY - 2007/1/24/entrez SP - 80 EP - 7 JF - International journal of pharmaceutics JO - Int J Pharm VL - 337 IS - 1-2 N2 - This study investigated the solid dispersion containing pellets of itraconazole for enhanced drug dissolution rate. The influence of process parameters used during high shear pelletization on the pellet properties including pellet size and dissolution rate was also studied. Solid dispersions of itraconazole were prepared with Eudragit E100, a hydrophilic polymer, by a simple fusion method followed by powdered and characterized by differential scanning calorimetry and X-ray powder diffraction. Solid dispersions containing pellets were consequently prepared using a lab-scale high shear mixer. In order to improve the product quality, a central composite design was applied to optimize the critical process variables, such as impeller speed and kneading time, and the results were modeled statistically. Itraconazole was presented as an amorphous state in the solid dispersion prepared at a drug to polymer ratio of 1:2. Both studied parameters had great effect on the responses. Powdered solid dispersion and pellets prepared using the optimal parameter settings showed approximately 30- and 70-fold increases in dissolution rate over the pure drug, respectively. Solid dispersion prepared by simple fusion method could be an option for itraconazole solubility enhancement. Pelletization process in high shear mixer can be optimized effectively by central composite design. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/17241757/Development_and_optimization_of_solid_dispersion_containing_pellets_of_itraconazole_prepared_by_high_shear_pelletization_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(06)01102-1 DB - PRIME DP - Unbound Medicine ER -