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Characterization and taste-masking evaluation of acetaminophen granules: comparison between different preparation methods in a high-shear mixer.
Eur J Pharm Sci. 2004 Feb; 21(2-3):295-303.EJ

Abstract

The aim of this study was to prepare and to investigate acetaminophen taste-masked granules obtained in a high-shear mixer using three different wet granulation methods (method A: water granulation, method B: granulation with a polyvinylpyrrolidone (PVP) binding solution and method C: steam granulation). The studied formulation was: acetaminophen 15%, alpha-lactose monohydrate 30%, cornstarch 45%, polyvinylpyrrolidone K30 5% and orange flavour 5% (w/w). In vitro dissolution studies, performed at pH 6.8, showed that steam granules enabled the lower dissolution rate in comparison to the water and binding solution granules; these results were then confirmed by their lower surface reactivity (D(R)) during the dissolution process. Moreover, the results of the gustatory sensation test performed by six volunteers confirmed the taste-masking effects of the granules, especially steam granules (P<0.001). Morphological, fractal and porosity analysis were then performed to explain the dissolution profiles and the results of the gustatory sensation test. Scanning electron microscopy (SEM) analysis revealed the smoother and the more regular surface of steam granules with respect to the samples obtained using methods A and B; these results were also confirmed by their lower fractal dimension (D(s)) and porosity values. Finally, differential scanning calorimetry (DSC) results showed a shift of the melting point of the drug, which was due to the simple mixing of the components and not to the granulation processes. In conclusion, the steam granulation technique resulted a suitable method to comply the purpose of this work, without modifying the availability of the drug.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, University of Bologna, Via S. Donato 19/2, 40127, Bologna, Italy. beatrice@biocfarm.unibo.itNo 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

14757501

Citation

Albertini, Beatrice, et al. "Characterization and Taste-masking Evaluation of Acetaminophen Granules: Comparison Between Different Preparation Methods in a High-shear Mixer." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 21, no. 2-3, 2004, pp. 295-303.
Albertini B, Cavallari C, Passerini N, et al. Characterization and taste-masking evaluation of acetaminophen granules: comparison between different preparation methods in a high-shear mixer. Eur J Pharm Sci. 2004;21(2-3):295-303.
Albertini, B., Cavallari, C., Passerini, N., Voinovich, D., González-Rodríguez, M. L., Magarotto, L., & Rodriguez, L. (2004). Characterization and taste-masking evaluation of acetaminophen granules: comparison between different preparation methods in a high-shear mixer. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 21(2-3), 295-303.
Albertini B, et al. Characterization and Taste-masking Evaluation of Acetaminophen Granules: Comparison Between Different Preparation Methods in a High-shear Mixer. Eur J Pharm Sci. 2004;21(2-3):295-303. PubMed PMID: 14757501.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Characterization and taste-masking evaluation of acetaminophen granules: comparison between different preparation methods in a high-shear mixer. AU - Albertini,Beatrice, AU - Cavallari,Cristina, AU - Passerini,Nadia, AU - Voinovich,Dario, AU - González-Rodríguez,Marisa L, AU - Magarotto,Lorenzo, AU - Rodriguez,Lorenzo, PY - 2004/2/6/pubmed PY - 2004/12/16/medline PY - 2004/2/6/entrez SP - 295 EP - 303 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 21 IS - 2-3 N2 - The aim of this study was to prepare and to investigate acetaminophen taste-masked granules obtained in a high-shear mixer using three different wet granulation methods (method A: water granulation, method B: granulation with a polyvinylpyrrolidone (PVP) binding solution and method C: steam granulation). The studied formulation was: acetaminophen 15%, alpha-lactose monohydrate 30%, cornstarch 45%, polyvinylpyrrolidone K30 5% and orange flavour 5% (w/w). In vitro dissolution studies, performed at pH 6.8, showed that steam granules enabled the lower dissolution rate in comparison to the water and binding solution granules; these results were then confirmed by their lower surface reactivity (D(R)) during the dissolution process. Moreover, the results of the gustatory sensation test performed by six volunteers confirmed the taste-masking effects of the granules, especially steam granules (P<0.001). Morphological, fractal and porosity analysis were then performed to explain the dissolution profiles and the results of the gustatory sensation test. Scanning electron microscopy (SEM) analysis revealed the smoother and the more regular surface of steam granules with respect to the samples obtained using methods A and B; these results were also confirmed by their lower fractal dimension (D(s)) and porosity values. Finally, differential scanning calorimetry (DSC) results showed a shift of the melting point of the drug, which was due to the simple mixing of the components and not to the granulation processes. In conclusion, the steam granulation technique resulted a suitable method to comply the purpose of this work, without modifying the availability of the drug. SN - 0928-0987 UR - https://www.unboundmedicine.com/medline/citation/14757501/Characterization_and_taste_masking_evaluation_of_acetaminophen_granules:_comparison_between_different_preparation_methods_in_a_high_shear_mixer_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928098703002926 DB - PRIME DP - Unbound Medicine ER -