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Preparation and characterization by morphological analysis of diclofenac/PEG 4000 granules obtained using three different techniques.
Int J Pharm. 2002 Aug 21; 242(1-2):285-9.IJ

Abstract

The steam granulation is a new wet granulation technique, which involves the use of steam water instead of traditional liquid water as granulation liquid. The aim of this work was to evaluate the possibility of using this new technique to prepare diclofenac-polyethylene glycol 4000 accelerated-release granules. Steam granules were prepared in a laboratory scale high-shear mixer, and their properties were then compared to those of granules, having the same composition, obtained by traditional granulation techniques (wet and melt granulation). The results showed that, selecting the proper process parameters, it was possible to obtain granules using all the three methods; however, the total process time was significantly shorter for steam granulation (30 min) in comparison to traditional wet granulation (70 min), due to the lower amount of used water. The morphological characterization of steam, water and melt granules, performed by scanning electron microscopy (SEM) and image analysis, revealed that steam granules had a more spherical shape and a larger surface area with respect to water and melt ones, suggesting a possible difference in dissolution behavior. Moreover, differential scanning calorimetry (DSC) and X-ray powder diffraction analysis evidenced the transformation of the drug from its originally crystalline form into the amorphous one. Finally, the in vitro dissolution tests showed an increased dissolution rate of the drug from the granules (in particular steam granules) in comparison to pure drug and physical mixture. In conclusion, the results of this study suggested that the steam granulation technique could be considered an interesting alternative to traditional wet granulation to improve the dissolution rate of diclofenac.

Authors+Show Affiliations

Dipartimento di Scienze Farmaceutiche, Università di Bologna, Via S. Donato 19/2, 40127, Bologna, Italy. rodrig@biocfarm.unibo.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12176265

Citation

Rodriguez, L, et al. "Preparation and Characterization By Morphological Analysis of diclofenac/PEG 4000 Granules Obtained Using Three Different Techniques." International Journal of Pharmaceutics, vol. 242, no. 1-2, 2002, pp. 285-9.
Rodriguez L, Cavallari C, Passerini N, et al. Preparation and characterization by morphological analysis of diclofenac/PEG 4000 granules obtained using three different techniques. Int J Pharm. 2002;242(1-2):285-9.
Rodriguez, L., Cavallari, C., Passerini, N., Albertini, B., González-Rodríguez, M., & Fini, A. (2002). Preparation and characterization by morphological analysis of diclofenac/PEG 4000 granules obtained using three different techniques. International Journal of Pharmaceutics, 242(1-2), 285-9.
Rodriguez L, et al. Preparation and Characterization By Morphological Analysis of diclofenac/PEG 4000 Granules Obtained Using Three Different Techniques. Int J Pharm. 2002 Aug 21;242(1-2):285-9. PubMed PMID: 12176265.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preparation and characterization by morphological analysis of diclofenac/PEG 4000 granules obtained using three different techniques. AU - Rodriguez,L, AU - Cavallari,C, AU - Passerini,N, AU - Albertini,B, AU - González-Rodríguez,M, AU - Fini,A, PY - 2002/8/15/pubmed PY - 2002/10/31/medline PY - 2002/8/15/entrez SP - 285 EP - 9 JF - International journal of pharmaceutics JO - Int J Pharm VL - 242 IS - 1-2 N2 - The steam granulation is a new wet granulation technique, which involves the use of steam water instead of traditional liquid water as granulation liquid. The aim of this work was to evaluate the possibility of using this new technique to prepare diclofenac-polyethylene glycol 4000 accelerated-release granules. Steam granules were prepared in a laboratory scale high-shear mixer, and their properties were then compared to those of granules, having the same composition, obtained by traditional granulation techniques (wet and melt granulation). The results showed that, selecting the proper process parameters, it was possible to obtain granules using all the three methods; however, the total process time was significantly shorter for steam granulation (30 min) in comparison to traditional wet granulation (70 min), due to the lower amount of used water. The morphological characterization of steam, water and melt granules, performed by scanning electron microscopy (SEM) and image analysis, revealed that steam granules had a more spherical shape and a larger surface area with respect to water and melt ones, suggesting a possible difference in dissolution behavior. Moreover, differential scanning calorimetry (DSC) and X-ray powder diffraction analysis evidenced the transformation of the drug from its originally crystalline form into the amorphous one. Finally, the in vitro dissolution tests showed an increased dissolution rate of the drug from the granules (in particular steam granules) in comparison to pure drug and physical mixture. In conclusion, the results of this study suggested that the steam granulation technique could be considered an interesting alternative to traditional wet granulation to improve the dissolution rate of diclofenac. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/12176265/Preparation_and_characterization_by_morphological_analysis_of_diclofenac/PEG_4000_granules_obtained_using_three_different_techniques_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378517302001898 DB - PRIME DP - Unbound Medicine ER -