Journal
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
Volume 119, Issue -, Pages 47-55Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejpb.2017.05.010
Keywords
Hot-melt extrusion; Melt rheology; Glass transition temperature; Amorphous solid dispersion; Small amplitude oscillatory shear; Prediction model
Categories
Ask authors/readers for more resources
The feasibility of predicting melt rheology by using the glass transition temperature (T-g) of a desired amorphous solid dispersion (ASD) for hot-melt extrusion (HME) and other melt based processes is presented. Three groups of three different active pharmaceutical ingredients (APIs) or plasticizer/copovidone mixtures, with identical glass transition in rheological testing, were used. Their rheological behavior as a function of temperature and frequency were analyzed by means of small amplitude oscillatory shear (SAOS) on an oscillatory rheometer. The zero-shear viscosity (no) identified at 150 degrees C was compared to Tg, measured by differential scanning calorimetry (DSC) and SAOS. A strong correlation between no and Tg was identified, independent of the API or plasticizer used to achieve Tg of the mixture. To evaluate and rate the discrepancy in no of the different mixtures at same Tg, hot-melt extrusion trials were conducted to measure torque and mean residence time. In this paper, carbamazepine, dipyridamole, indomethacin, ibuprofen, polyethylene glycol (PEG 1500) in vinylpyrrolidone-vinyl acetate copolymer (copovidone) as matrix polymer were used. (C) 2017 Published by Elsevier B.V.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available