Tablet Color Changes Due to Light Irradiation and Titanium Dioxide: Color Change Prevention Using Plasticizers

AAPS PharmSciTech. 2025 May 20;26(5):142. doi: 10.1208/s12249-025-03132-5.

Abstract

The color and shape of the tablets manufactured by pharmaceutical companies were selected with branding and anti-counterfeiting measures in mind. Our previous report clarified that the discoloration of tablets by light exposure is due to the degradation of hydroxypropyl methylcellulose in the coating film and that the degradation reaction is triggered by TiO2. In this study, we identified a pharmaceutical excipient that prevents light-induced discoloration of the coating film mediated by TiO2. Among the excipients examined, triethyl citrate and glycerol triacetate, which are used as plasticizers, prevented color changes in the tablets. The prevention of color change was attributed to increased tensile strength rather than the coating film's glassy or rubbery state. In conclusion, the color change of tablets owing to photochemical reactions with TiO2 can be prevented by using excipients which can increase the strength of the coating film.

Keywords: coating film; color; light irradiation; plasticizer; titanium dioxide.

MeSH terms

  • Chemistry, Pharmaceutical / methods
  • Citrates / chemistry
  • Color
  • Excipients / chemistry
  • Light*
  • Plasticizers* / chemistry
  • Tablets* / chemistry
  • Tablets* / radiation effects
  • Tensile Strength
  • Titanium* / chemistry

Substances

  • Titanium
  • Plasticizers
  • titanium dioxide
  • Excipients
  • Tablets
  • Citrates
  • ethyl citrate