A Study of the Effect of Certain Pharmaceutical Materials on Color Stability**Research Department, Ciba Pharmaceutical Products Inc., Summit, N. J.

Kuramoto, Roy; Lachman, Leon; Cooper, Jack

doi:10.1002/jps.3030470308

Cited by 17 publications

(5 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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.…”

Section: Light Sensitivity Of Solid Dosage Formsmentioning

confidence: 99%

See 1 more Smart Citation

Stability of Solids and Solid Dosage Forms

Carstensen

1974

Journal of Pharmaceutical Sciences

156

View full text Add to dashboard Cite

Section: Light Sensitivity Of Solid Dosage Formsmentioning

confidence: 99%

“…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).…”

Section: Light Sensitivity Of Solid Dosage Formsmentioning

confidence: 99%

Stability of Solids and Solid Dosage Forms

Carstensen

1974

Journal of Pharmaceutical Sciences

156

View full text Add to dashboard Cite

“…Although the photodecomposition of indigocarmine appears to be the main cause of colour instability, the thermal decomposition of this dye in solution has been reported [4][5][6][7]. From the Arrhenius plot of the dye at pH 7.0, a half-life of 234 days at 25 ~ was reported [6].…”

mentioning

confidence: 97%

“…This dye has been used as an indicator in the titration ", 0 of antimony(V) with titanium(Ill) [1] and of iron(Ill)with chromium(ll) [2,3] in an atmosphere of carbon dioxide. Studies carried out in solution on the colour-fading of this dye have indicated that the fading is due to oxidation-reduction processes as well as to a dependency on the light intensity [4].Although the photodecomposition of indigocarmine appears to be the main cause of colour instability, the thermal decomposition of this dye in solution has been reported [4][5][6][7]. From the Arrhenius plot of the dye at pH 7.0, a half-life of 234 days at 25 ~ was reported [6].…”

mentioning

confidence: 98%

Synthesis, characterization and thermal behaviour of some metal indigodisulphonates

Salas-Peregrín

Suárez‐Varela

1984

Journal of Thermal Analysis

View full text Add to dashboard Cite

Some indigodisulphonates of Cr(lll), Cu(ll), Ag(I ), An (11) and Cd (11) have been prepared in aqueous medium and characterized on the basis of elemental analyses, diffuse reflectance infrared spectra and magnetic measurements.The thermal behaviours of these salts were studied by TG, DTG and DSC techniques. Cr(lll), Cu(ll), Zn(ll) amd Cd(ll) indigodisulphonates contain 12, 2, 2 and 2 molecules of crystallization water, respectively. The end-products of thermal decomposition have been verified by infrared spectroScopy and X-ray diffraction. Values of dehydration enthalpies have been calculated from the DSC curves.The synthetic food dye indigocarmine, is the disodium salt of l-indigotin-5,5'-disulphonic acid (Structure 1). This dye has been used as an indicator in the titration ", 0 of antimony(V) with titanium(Ill) [1] and of iron(Ill)with chromium(ll) [2,3] in an atmosphere of carbon dioxide. Studies carried out in solution on the colour-fading of this dye have indicated that the fading is due to oxidation-reduction processes as well as to a dependency on the light intensity [4].Although the photodecomposition of indigocarmine appears to be the main cause of colour instability, the thermal decomposition of this dye in solution has been reported [4][5][6][7]. From the Arrhenius plot of the dye at pH 7.0, a half-life of 234 days at 25 ~ was reported [6].No studies have been performed in the solid phase on the thermal stability of indigodisu Iphonates.The aim of the present paper was to investigate the thermal behaviours of several indigodisulphonates in the solid phase, using thermogravimetric and differential scanning calorimetry methods.

show abstract

“…Some materials used as pharmaceutical excipients such as dextrose, lactose and sucrose in solutions also increased fading rate of FD&C blue no. 2, while mannitol and sorbitol did not (49).…”

Section: Color Stabilitymentioning

confidence: 90%

Effect of degradation of peg 600 on color fading and crosslinking in soft gelatin capsule shell

Nittayasoot

View full text Add to dashboard Cite

?Autoxidation of polyethylene glycol (PEG) 600, which is a hydrophilic liquid commonly filled in soft gelatin capsules, results in formaldehyde which is an oxidizing agent.? The objectives of the present study were to study the effect of formaldehyde on fading of brilliant blue dye and crosslinking in the soft gelatin capsules; also to investigate possibility of inhibition of PEG 600 autoxidation by a selected antioxidant.? Nine PEG 600 based fill formulations were prepared according to a full factorial design with 2 factors and 3 levels of water (0, 5, 10 %w/w) and an antioxidant, i.e. d-?-tocopherol (0, 0.001, 0.05 %w/w). They were encapsulated in non-colored and brilliant blue colored shells.? The capsules were stored in ambler glass bottles under 30oC/75%RH for 90 days. Physicochemical properties of capsules were evaluated. ?The results showed that autoxidation of PEG 600 occurred and initial water content in the formulation had a significant effect on formaldehyde formation analyzed at 14 days (p-value = 0.001).? The maximum level of d-?-tocopherol used in this study could not inhibit PEG 600 autoxidation. Color fading was not visually observed. However, delta E of capsule shells at 90 days was increased from that at first day and the total color content was reduced in some formulations. Brilliant blue in the shell was found to migrate into PEG 600 based liquid fill. ?Moreover, crosslinking of the gelatin shell could be detected by FT-IR spectroscopy and it was confirmed by dissolution results.? Overall, it could be concluded that autoxidation of PEG 600 resulting in formaldehyde which could cause a problem of gelatin cross-linking, rather than fading of brilliant blue dye.

show abstract

A Study of the Effect of Certain Pharmaceutical Materials on Color Stability**Research Department, Ciba Pharmaceutical Products Inc., Summit, N. J.

Cited by 17 publications

References 4 publications

Stability of Solids and Solid Dosage Forms

Stability of Solids and Solid Dosage Forms

Synthesis, characterization and thermal behaviour of some metal indigodisulphonates

Effect of degradation of peg 600 on color fading and crosslinking in soft gelatin capsule shell

Contact Info

Product

Resources

About