The study describes the dissolution testing of several disintegrants and eight cationic drug actives formulated in direct-compression
tablets, all prepared using a model formulation. The test disintegrants included Polyplasdone XL Crospovidone, Polyplasone
XL-10 Crospovidone superdisintegrants, and the anionic disintegrants sodium starch glycolate and croscarmellose sodium. Polyplasdone
XL Crospovidone and Polyplasone XL-10 Crospovidone are synthetic, insoluble, but swellable, cross-linked homopolymers of N-vinyl-2-pyrrolidone
that differ only in particle size.
ISP reported that the two disintegrants (Polyplasdone XL Crospovidone, Polyplasone XL-10 Crospovidone) provide fast dissolution
not only for freely soluble, cationic drug actives such as chlorpromazine hydrochloride, ranitidine hydrochloride, cetirizine
hydrochloride, and venlafaxine hydrochloride, but also for cationic actives with low water solubility such as ciprofloxacin
hydrochloride, fexofenadine hydrochloride, terbi-nafine hydrochloride, and clopidogrel bisulfate.
References
1. G. S. Morris and J.Huang, "China Emerges as the Next Frontier for Specialty Excipients," Pharm. Technol.
30
Technology Outlook; APIs, Intermediates, and Formulation supplement, s26–s30 (2006).
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