Preliminary assessment of an image analysis method for the evaluation of pharmaceutical coatings

Pharmaceutical Development and Technology
J P Kennedy, P J Niebergall

Abstract

This article describes the development and preliminary assessment of an innovative image analysis method for the evaluation of pharmaceutical coatings. Nonpareils previously hot-melt coated with a red water-soluble dye incorporated into polyethylene glycol were employed to develop and evaluate the new method. Digital images of batch samples were acquired and transferred to a PC for evaluation by image analysis software. Standard deviations generated for the optical densities of individual nonpareils in each batch sample were utilized to evaluate coating uniformity. Mean optical densities generated for each batch sample were used to evaluate the mean coating thickness. Method precision determinations, using an average sample size of 221 nonpareils, returned a relative standard deviation of 2.47% for coating uniformity and 1.71% for coating thickness. The new method is rapid, objective, and relatively inexpensive. It proved to be both qualitative and quantitative for coating uniformity, qualitative for coating thickness, and maintained a high degree of precision. The method can be used independently or in conjunction with other methods to eliminate their subjective aspects regarding sample selection.

References

Apr 1, 1996·Pharmaceutical Development and Technology·J P Kennedy, P J Niebergall

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Citations

Dec 16, 2005·AAPS PharmSciTech·Preetanshu Pandey, Richard Turton
Feb 6, 2013·International Journal of Pharmaceutics·Klaus Knop, Peter Kleinebudde
Feb 9, 2010·International Journal of Pharmaceutics·Sagarika Bose, Robin H Bogner
Jan 18, 2007·The Journal of Pharmacy and Pharmacology·Osmo AntikainenNiklas Sandler
Jan 20, 2012·Pharmaceutical Development and Technology·Ekneet Sahni, Bodhisattwa Chaudhuri
Mar 22, 2005·Pharmaceutical Development and Technology·Grant HeinickeJoseph B Schwartz
Dec 8, 2004·Pharmaceutical Development and Technology·Grant Heinicke, Joseph B Schwartz
Jun 15, 2010·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Miha MozinaBostjan Likar
May 6, 2014·International Journal of Pharmaceutics·Nika Oman KaduncDejan Tomaževič

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