Tags

Type your tag names separated by a space and hit enter

Agglomeration of mesoporous silica by melt and steam granulation. Part I: a comparison between disordered and ordered mesoporous silica.
J Pharm Sci. 2013 Nov; 102(11):3966-77.JP

Abstract

The objective of this study was to compare agglomerations by melt and steam granulation of ordered, COK-12, and disordered, Syloid(®) 244 FP (244), mesoporous silica material. Poloxamer 188 (P188) and polyvinylpyrrolidone K25 (PVP) were chosen as binders for melt and steam granulation, respectively. The poorly water-soluble compound, itraconazole (ITZ), was selected for the development of an immediate-release oral dosage form. Steam granulation resulted in the largest granules, however, the slowest release. Compression behavior and tablet properties of steam-granulated material prepared with COK-12 and 244 were similar. As determined by X-ray powder diffraction, melt granulation resulted in the most ITZ to extract from the pores during processing. However, the enhanced release rate was still maintained when compared with the crystalline form. Moreover, no additional drug extraction was observed following the 6 month storage in 25°C/60% relative humidity (RH) and 40°C/75%RH. P188 diffraction peaks were present in the 244 melt-granulated material, but disappeared because of the degradation following 1 week in 40°C/75%RH conditions. The differential scanning calorimetry analysis indicated that the degradation of P188 already occurred during the granulation process itself. Based on these results, steam granulation with PVP is the preferred method over melt granulation with P188.

Authors+Show Affiliations

Drug Delivery and Disposition, KU Leuven, Leuven, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23946143

Citation

Vialpando, Monica, et al. "Agglomeration of Mesoporous Silica By Melt and Steam Granulation. Part I: a Comparison Between Disordered and Ordered Mesoporous Silica." Journal of Pharmaceutical Sciences, vol. 102, no. 11, 2013, pp. 3966-77.
Vialpando M, Albertini B, Passerini N, et al. Agglomeration of mesoporous silica by melt and steam granulation. Part I: a comparison between disordered and ordered mesoporous silica. J Pharm Sci. 2013;102(11):3966-77.
Vialpando, M., Albertini, B., Passerini, N., Bergers, D., Rombaut, P., Martens, J. A., & Van Den Mooter, G. (2013). Agglomeration of mesoporous silica by melt and steam granulation. Part I: a comparison between disordered and ordered mesoporous silica. Journal of Pharmaceutical Sciences, 102(11), 3966-77. https://doi.org/10.1002/jps.23700
Vialpando M, et al. Agglomeration of Mesoporous Silica By Melt and Steam Granulation. Part I: a Comparison Between Disordered and Ordered Mesoporous Silica. J Pharm Sci. 2013;102(11):3966-77. PubMed PMID: 23946143.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Agglomeration of mesoporous silica by melt and steam granulation. Part I: a comparison between disordered and ordered mesoporous silica. AU - Vialpando,Monica, AU - Albertini,Beatrice, AU - Passerini,Nadia, AU - Bergers,Daan, AU - Rombaut,Patrick, AU - Martens,Johan A, AU - Van Den Mooter,Guy, Y1 - 2013/08/14/ PY - 2013/06/13/received PY - 2013/07/22/revised PY - 2013/07/24/accepted PY - 2013/8/16/entrez PY - 2013/8/16/pubmed PY - 2014/5/6/medline KW - compaction KW - compression KW - formulation KW - granulation KW - oral drug delivery KW - physical characterization KW - poorly water-soluble drugs KW - solid dosage form SP - 3966 EP - 77 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 102 IS - 11 N2 - The objective of this study was to compare agglomerations by melt and steam granulation of ordered, COK-12, and disordered, Syloid(®) 244 FP (244), mesoporous silica material. Poloxamer 188 (P188) and polyvinylpyrrolidone K25 (PVP) were chosen as binders for melt and steam granulation, respectively. The poorly water-soluble compound, itraconazole (ITZ), was selected for the development of an immediate-release oral dosage form. Steam granulation resulted in the largest granules, however, the slowest release. Compression behavior and tablet properties of steam-granulated material prepared with COK-12 and 244 were similar. As determined by X-ray powder diffraction, melt granulation resulted in the most ITZ to extract from the pores during processing. However, the enhanced release rate was still maintained when compared with the crystalline form. Moreover, no additional drug extraction was observed following the 6 month storage in 25°C/60% relative humidity (RH) and 40°C/75%RH. P188 diffraction peaks were present in the 244 melt-granulated material, but disappeared because of the degradation following 1 week in 40°C/75%RH conditions. The differential scanning calorimetry analysis indicated that the degradation of P188 already occurred during the granulation process itself. Based on these results, steam granulation with PVP is the preferred method over melt granulation with P188. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/23946143/Agglomeration_of_mesoporous_silica_by_melt_and_steam_granulation__Part_I:_a_comparison_between_disordered_and_ordered_mesoporous_silica_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(15)30854-6 DB - PRIME DP - Unbound Medicine ER -