Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 104, Issue 1, Pages 44-51Publisher
WILEY-BLACKWELL
DOI: 10.1002/jps.24207
Keywords
solubility; amorphous; solid dispersion; supersaturation; polymers; spray drying; solvent evaporation; milling; calorimetry (DSC)
Ask authors/readers for more resources
In this study, the influence of the preparation technique (ball milling, spray drying, and film casting) of a supersaturated amorphous dispersion on the quality of solubility determinations of indomethacin in polyvinylpyrrolidone was investigated by means of statistical analysis. After annealing of the amorphous dispersions above the crystallization temperature for 2 h, the solubility curve was derived from the glass transition temperature of the demixed material using the Gordon-Taylor relationship and fitting with the Flory-Huggins model. The study showed that the predicted solubility from the ball-milled mixtures was not consistent with those from spray drying and film casting, indicating fundamental differences between the preparation techniques. Through formal statistical analysis, the best combination of fit to the Flory-Huggins model and reproducibility of the measurements was analyzed. Ball milling provided the best reproducibility of the three preparation techniques; however, an analysis of residuals revealed a systematic error. In contrast, film casting demonstrated a good fit to the model but poor reproducibility of the measurements. Therefore, this study recommends that techniques such as spray drying or potentially film casting (if experimental reproducibility can be improved) should be used to prepare the amorphous dispersions when performing solubility measurements of this kind. (c) 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:44-51, 2015
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