Formulation and Delivery
Giovanni Raspantini, PharmD (he/him/his)
Application Specialist
MilliporeSigma a Business of Merck KGaA
Darmstadt, Hessen, Germany
Uniform white coatings applied to tablets create a homogeneous appearance, improving patient compliance. Titanium dioxide is used extensively in solid dosage forms for this purpose, serving as an opacifier and colorant. Toxicological concerns and the possible ban in some jurisdictions have led to an increased interest in suitable alternatives. Due to its regulatory status and safety profile, calcium carbonate is currently seen as the most likely alternative. This talk highlights how a uniform tablet finishing and good opacity can be enabled by a calcium carbonate with a homogeneous particle morphology and a designed particle size distribution while maintaining a good process efficiency. Comprehensive study results of color measurements are presented in comparison to the industry benchmark titanium dioxide. The proposed color measurement technique represents a suitable tool to quantify opacity and whiteness and can be utilized to optimize the final finishing in the formulation development.