Stability of Certified Dyes in Tablets III

Integrating Tristimulus Colorimetry into Pharmaceutical Development for Color Selection and Physical Appearance Control: A Quality-by-Design Approach

“…It is well known that certain factors (e.g., light, heat, and humidity) can lead to degradation and a potential change in physical appearance over time 8,30,31. Therefore, it is important to understand the inherent stability associated with a particular color coating 10. During typical stability studies under ICH conditions (e.g., 25°C/60% RH and 40°C/75% RH), the drug product is packaged and a visual appearance analysis would be conducted throughout the stability study.…”

“…8,30,31 Therefore, it is important to understand the inherent stability associated with a particular color coating. 10 During typical stability studies under ICH conditions (e.g., 25 • C/60% RH and 40 • C/ 75% RH), the drug product is packaged and a visual appearance analysis would be conducted throughout the stability study. Before embarking on this type of long-term study, it is important to understand the potential liability associated with color change.…”

“…The effect of heat and humidity on the color stability of tablets coated with six different blue color coatings was evaluated by instrumental colorimetry. Blue coatings were the focus of this study because they have historically presented problems from a visual color stability standpoint, and blue has been designated an unstable dye by Goodhart et al 10 The purpose of this in-depth study was to select the blue color coating least likely to change color over the shelf-life of the product. The proprietary color coatings studied here and their visual description are summarized in Table 2.…”

“…In addition, Matsuda et al9 demonstrated that color development and fading can be caused by light irradiation, but could be minimized through addition of an ultraviolet (UV) absorber to the polymeric color coating. The stability of color coatings generated with organic dyes, including blue and green, has proven to be particularly troublesome for development efforts 10. Although visible color change may or may not be related to an actual change in potency, patients and pharmacists may perceive a visual color change as a sign of sub‐potency or other undefined changes in product quality.…”

“…The stability of color coatings generated with organic dyes, including blue and green, has proven to be particularly troublesome for development efforts. 10 Although visible color change may or may not be related to an actual change in potency, patients and pharmacists may perceive a visual color change as a sign of sub-potency or other undefined changes in product quality. Yamazaki et al 7 reported that even slight color changes in aspirin tablets resulted in pharmacists discarding the product, likely due to perceived decomposition of the active ingredient.…”