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Phase Transformations of Erythromycin A Dihydrate During Pelletisation and Drying

Phase Transformations of Erythromycin A Dihydrate During Pelletisation and Drying

Meike Römer, Jyrki Heinämäki, Inna Miroshnyk, Niklas Sandler, Jukka Rantanen, Jouko Yliruusi

Eur J Pharm Biopharm. 2007 Aug;67(1):246-52.

PMID: 17270405

Abstract:

An at-line process analytical approach was applied to better understand process-induced transformations of erythromycin dihydrate during pellet manufacture (extrusion-spheronisation and drying process). The pellets contained 50% (w/w) erythromycin dihydrate and 50% (w/w) microcrystalline cellulose, with purified water used as a granulating fluid. To characterise changes in solid-state properties during processing, near infrared (NIR) spectroscopy and X-ray powder diffraction (XRPD) were applied. Samples were taken after every processing step (blending, granulation, extrusion, and spheronisation) and at predetermined intervals during drying at 30 or 60 degrees C. During pelletisation and drying at 30 degrees C no changes occurred. Partial transformation to the dehydrated form was observed for the pellets dried at 60 degrees C by NIR and XRPD. The variable temperature XRPD measurements of the wet pellets (from 25 to 200 degrees C) also confirmed the change to erythromycin dehydrate at approximately 60 degrees C.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP59319721	Erythromycin A dihydrate		59319-72-1	Price

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