Effect of high shear blending protocols and blender parameters on the degree of API agglomeration in solid formulations / Marcos Llusa in Industrial & engineering chemistry research, Vol. 48 N°1 (Janvier 2009)  

Public ISBD [article]  inIndustrial & engineering chemistry research > Vol. 48 N°1 (Janvier 2009) . - p. 93-101 Titre : Effect of high shear blending protocols and blender parameters on the degree of API agglomeration in solid formulations Type de document : texte imprimé Auteurs : Marcos Llusa, Éditeur scientifique ; Kurt Sturm, Éditeur scientifique ; Osama Sudah, Éditeur scientifique Année de publication : 2009 Article en page(s) : p. 93-101 Note générale : Chemical engineering Langues : Anglais (eng) Mots-clés : Active pharmaceutical ingredient (API) API agglomeration Solid formulations Résumé : This paper examines the effect of three protocols with several units and blender parameters on the mitigation of active pharmaceutical ingredient (API) agglomeration in solid formulations. The three protocols either preblend API with a portion of excipients in a high shear unit followed by dilution in a large blender or prepare the entire blend in a single blender followed by milling. In general, the three protocols yield blends with statistically similar API concentration variance and deagglomeration. The scale-up of the three protocols leads to more extensive API deagglomeration, which suggests that blender parameters still influence the degree of API deagglomeration, even when high shear units are present in the protocol. Lower blender fill levels and larger blenders lead to blends with fewer API agglomerates. Regarding the use of blender internals, results show that baffles have no substantial effect on API agglomeration. The inclusion of a moving internal (i.e., impeller) in a bin blender may not always lead to blends with fewer API agglomerates. The design and the positioning of the impeller play an important role as well. En ligne : http://pubs.acs.org/doi/abs/10.1021/ie8007055 [article] Effect of high shear blending protocols and blender parameters on the degree of API agglomeration in solid formulations [texte imprimé] / Marcos Llusa, Éditeur scientifique ; Kurt Sturm, Éditeur scientifique ; Osama Sudah, Éditeur scientifique . - 2009 . - p. 93-101. Chemical engineering Langues : Anglais (eng) in Industrial & engineering chemistry research > Vol. 48 N°1 (Janvier 2009) . - p. 93-101 Mots-clés : Active pharmaceutical ingredient (API) API agglomeration Solid formulations Résumé : This paper examines the effect of three protocols with several units and blender parameters on the mitigation of active pharmaceutical ingredient (API) agglomeration in solid formulations. The three protocols either preblend API with a portion of excipients in a high shear unit followed by dilution in a large blender or prepare the entire blend in a single blender followed by milling. In general, the three protocols yield blends with statistically similar API concentration variance and deagglomeration. The scale-up of the three protocols leads to more extensive API deagglomeration, which suggests that blender parameters still influence the degree of API deagglomeration, even when high shear units are present in the protocol. Lower blender fill levels and larger blenders lead to blends with fewer API agglomerates. Regarding the use of blender internals, results show that baffles have no substantial effect on API agglomeration. The inclusion of a moving internal (i.e., impeller) in a bin blender may not always lead to blends with fewer API agglomerates. The design and the positioning of the impeller play an important role as well. En ligne : http://pubs.acs.org/doi/abs/10.1021/ie8007055

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