US EPA

6410815 

Journal Article 

Assessing the use of food coloring as an appropriate visual guide for homogenously mixed capsule powders in extemporaneous compounding 

Hoffmann, B; Carlson, C; Rao, DA 

2014 

Yes 

International Journal of Pharmaceutical Compounding
ISSN: 1092-4221 

18 

4 

341-344 

English 

25474863 

The purpose of this work was to assess the use of food colors as a visual aid to determine homogeneous mixing in the extemporaneous preparation of capsules. Six different batches of progesterone slow-release 200-mg capsules were prepared by different mixing methods until visually determined as homogeneous based on yellow food coloring distribution in the preparation by the Central Iowa Compounding Pharmacy, Des Moines, Iowa. UV-Vis spectrophotometry was used to extract and evaluate yellow food coloring content in each of these batches and compared to an in-house, small-batch geometric dilution preparation of progesterone slow- release 200-mg capsules. Of the 6 batches tested, only one, which followed the principles of additive dilution and an appropriate mixing time, was both visually and quantitatively homogeneous in the detection of yellow food coloring. The use of food coloring alone is not a valid quality-assurance tool in determining homogeneous mixing. Principles of geometric and/or additive dilution and appropriate mixing times along with the food color can serve as a quality-assurance tool.