Expanding Opportunities for Specialty Excipients - Pharmaceutical Technology

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Expanding Opportunities for Specialty Excipients
China creates a potential outlet for specialty excipients as its pharmaceutical market grows.


Pharmaceutical Technology


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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