As the pharmaceutical industry seeks to mitigate risks associated with titanium dioxide (TiO2) due to continued regulatory uncertainty, the exploration of alternatives in solid oral dosage forms has become paramount. This rapid fire delves into the technical challenges surrounding the use of TiO2 alternatives for immediate release solid oral dosage forms and outlines the needs of the pharmaceutical industry that the currently available solutions are not providing. This session will highlight the necessity for: 1) defining the critical quality attribute(s) of the various alternatives currently utilized and why different grades of the same alternative may result in a different drug product performance, 2) understanding the performance of the alternatives with respect to the color mixture suspension preparation and application, and 3) consideration of the interplay between the polymer system and alternatives resulting in variations in the appearance and opacity of the drug product.
Learning Objectives:
Gain an appreciation of the current uncertainty surrounding the continued use of titanium dioxide globally.
Recognize the efforts the pharmaceutical industry has undertaken to understand alternatives to titanium dioxide for film coatings and the extensive collaborations with ready-made color mixture supplier.
Highlight the need to understand the critical quality attributes of alternatives to titanium dioxide and their influence on finished product performance (appearance and opacity).
