Color Stability of Tablet Formulations V

Stability of Solids and Solid Dosage Forms

“…Other reports (113)(114)(115)(116)(117)(118)(119)(120) established that the decay pattern consists of three consecutive first-order decays (Fig. 28) and stressed that the fad- 1 3 1 1 3 3 0 2 1 2 0 1 3 4 2 3 3 5 3 5 0 3 2 4 38 49 34 43 37 38 42 60 38 45 44 49 38 65 46 66 39 40 39 47 41 50 41 63 ~~ 31 38 30 35 32 35 31 38 30 34 31 35 32 56 36 53 34 37 31 45 28 45 34 61 a Values in fourth and fifth columns represent scoring from 1 to 6 for degree of color change (1 = unchanged, 6 = substantially changed) and from 1 to 6 for degree of fineness change.…”

“…It has been established (113)(114)(115)(116)(117)(118) that when the fading has penetrated to a depth of 0.03 cm, the tablet surface appears white and that the faded layer does not become thicker upon further light exposure. This has also been demonstrated for plastics (121)(122)(123).…”

Measurement of Surface Color and Color Difference of Tablet Colorants by Tristimulus Colorimetry

“…4 Precision Gage and Tool Co., Dayton, Ohio. 5 Beckman DB-G spectrophotometer with reflectance attachment, Beckman Instruments, Fullerton, Calif.…”

“…Some work also has been reported on color determination and color control in the food industry (3, 4). More recently, colorimetry has been employed in the determination of color stability of pharmaceutical tablet formulations (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18) and in the production of color matches for solid dosage forms (19)(20)(21). This work describes the measurement of surface color by tristimulus colorimetry and the determination of color specifications for the routine control of tablet colorants.…”

Influence of Sunscreening Agents on Color Stability of Tablets Coated with Certified Dyes II: FD&C Blue No. 1

“…UV absorbers (sunscreening agents) have been reported (1)(2)(3)(4)(5) to have a degree of effectiveness in preventing or slowing color fading under varying conditions of light exposure. Basically five types of UV absorbers have been found useful: benzoates, benzophenones, benzotriazoles, cinnamates, and salicylates.…”