Colorants are mainly used to impart a distinctive appearance to the pharmaceutical dosage forms. There are many types of pharmaceutical formulations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments and salves etc. The purpose of coloring varies with different formulations. Coloring may be required to increase the aesthetic appearance or to prolong the stability or to produce standard preparations or for identification of a particular formulation. Color psychology says that, the color of the product may also influence the efficacy of therapy. Thus, the prime priority of colorants is to increase the aesthetic appearance of the product, so we can say that the colorants are the cosmetics for the pharmaceutical formulations. The classification of various colorants including FD&C categories, the lists of colorants and their uses, the description about major colorants widely used in the formulations was discussed here in detail. In many regions around the world there is a distinction between colors that may be used in drugs and those for food use. This review also discusses the Status of color additives based on Code of Federal Regulations, The international regulatory status, Coloring systems for various dosage forms, Colorant blending, Handling precautions, Safety, Stability and Storage data of various colorants. Legislations, which govern the usage of colorants, include European Union Legislation and United States Legislation.
[1]
Loyd V. Allen,et al.
Ansel'S Pharmaceutical Dosage Forms And Drug Delivery Systems
,
2007
.
[2]
Grace Frimpong.
Investigating the suitability of hibiscus sabdariffa calyx extract as colouring agent for paediatric syrups
,
2008
.
[3]
S. Smolinske.
CRC Handbook of Food, Drug, and Cosmetic Excipients
,
1992
.
[4]
A. Dietemann-Molard,et al.
Extrinsic allergic alveolitis secondary to carmine
,
1991,
The Lancet.
[5]
H. Lévesque,et al.
Reporting adverse drug reactions by proprietary name
,
1991,
The Lancet.
[6]
T. Bell.
Colourants and drug reactions
,
1991,
The Lancet.
[7]
J. Sunil.
Pharmaceutical Dosage Forms: Tablets. Vol. 1.
,
1990
.
[8]
N. G. Popovich,et al.
Pharmaceutical Dosage Forms and Drug Delivery Systems
,
1990
.
[9]
J. Warner,et al.
Survey of colourings and preservatives in drugs.
,
1989,
BMJ.
[10]
I. Bernstein,et al.
Adverse reactions to drug formulation agents : a handbook of excipients
,
1989
.
[11]
R. Rowe.
The opacity of tablet film coatings
,
1984,
The Journal of pharmacy and pharmacology.
[12]
H. Lieberman,et al.
Pharmaceutical dosage forms : tablets
,
1980
.
[13]
S. Spector,et al.
Aspirin and concomitant idiosyncrasies in adult asthmatic patients.
,
1979,
The Journal of allergy and clinical immunology.
[14]
G. Settipane,et al.
Asthma caused by FD&C approved dyes.
,
1967,
The Journal of allergy.