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Experimental study on the influence of excipients on the heterogeneous crystallization and dissolution properties of an active pharmaceutical ingredient

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posted on 2018-02-23, 10:10 authored by Vivek Verma, Raghu V.G. Peddapatla, Clare M. Crowley, Abina M. Crean, PETER DAVERNPETER DAVERN, Sarah P. Hudson, Benjamin K. Hodnett
This study is based on the heterogeneous nucleation of active pharmaceutical ingredients (APIs) in the presence of various excipients widely used in the pharmaceutical industry. Carbamazepine (CBMZ) was successfully crystallized in the presence of the following heterosurfaces: alpha/beta-lactose, beta-D-mannitol, micro crystalline cellulose, and carboxymethyl cellulose. The successful crystallization of CBMZ FIII in the presence of all the excipients was confirmed by powder X-ray diffraction and scanning electron microscopy, while CBMZ crystals' apposition was confirmed using in situ scanning electronic microscopy-Raman. A pronounced improvement in the dissolution of CBMZ FIII was observed when crystallized in the presence of excipients when compared with CBMZ FIII recrystallized using the same conditions in the absence of the excipients. The isolated solids could be simply tabletted by direct compression upon mixing with the desired amount of disintegrant and lubricant. Hence employing this process could potentially streamline the downstream process in pharmaceutical industries and also increase the throughput with reduced cost.

History

Publication

Crystal Growth and Design;18, (1), pp. 338-350

Publisher

American Chemical Society

Note

peer-reviewed

Other Funding information

SFI

Rights

© 2018 ACS This document is the Accepted Manuscript version of a Published Work that appeared in final form in Journal Title, copyright © American Chemical Society after peer review and technical editing by the publisher. To access the final edited and published work see http://dx.doi.org/10.1021/acs.cgd.7b01336

Language

English

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