This document provides an overview of colouring agents used in pharmaceuticals. It discusses the history and categories of food colours, including natural, nature-identical, and artificial colours. Colourants are used in pharmaceuticals to improve appearance, identification, and stability. The document outlines the ideal properties of colourants and permitted natural colours in India. It also describes the widely used synthetic dyes and limitations of natural food colours.

1. COLOURING AGENT
Presented by
Ms.Rashmi Nasare
M. Pharm 1nd yr
Under the supervision of
Dr. Sheelpriya Walde
Professor
M.Pharm , Ph.D., MBA

2. • INTRODUCTION
• HISTORY OF FOOD COLOURS
• CATEGORIES OF FOOD COLOURS
• WHY FOOD COLOURS
• FUTURE PROSPECT OF NATURAL FOOD COLOURS
• PHARMACEUTICAL PREPARATION ARE COLORED FOR FOLLOWING REASONS
• IDEAL PROPERTIES OF A COLORANT
• PERMITTED NATURAL COLORS
• CLASSIFICATION
• WIDELY USED COLORANT IN PHARMACEUTICALS
• LIMITATIONS OF USING NATURAL FOOD COLOUR
CONTENT

3. INTRODUCTION
Defination :- A colour additive is a dye, pigment or other substance, whether synthetic or
derived for of vegetable, animal, mineral or other source, which imparts a colour when
added or applied to food, drug, cosmetics, or the human body{sec.201(t)}.
Colorant or colouring agents are mainly used to impart a distinctive appearance to the
pharmaceutical dosage forms.
We can also say that the colourant are the cosmetics for the pharmaceutical preparations,
because the aesthetic appearance of dosage forms can be enhanced by using suitable
colourants.

4. HISTORY OF FOOD COLOURS
Around 1200 BC, Cleopatra & other added saffron in butter as first colourant to put
a rich yellow colour.
Around 1500 BC, candy makers in Egyptian cities added natural extracts & wine to
improve the products appearance.
In 1856,William henry perkin discovered the first artificial organic dye, called
“mauve” by oxidizing aniline while trying to form an anti-malaria drug (quinine).
By 1900, many foods & drug in U.S. were artificially coloured with many blatantly
poisonous material such as lead, arsenic &mercury to hide inferior or defective
foods.
In 2009,barry Callebaut’s IBC brand specialized in colour & printing technology in
food applications has launched power flowers by tempering cocoa butter & 40%
coloring agent.

5. CATEGORIES OF FOOD COLOURS
• Natural colours:- pigments made by living organisms. Eg- luetin, beetroot
extract, annatto.
• Nature-identical colours:- Man made pigments which are also found in
nature. Eg- beta-carotene.
• Artificial colours:- Artificial colours are purely man-made colours. Eg-alura
red, brilliant blue,etc.
WHY FOOD COLOuRS:-
• To maintain or improve safety & freshness.
• To maintain or improve nutritional value.
• To improve taste, texture & appearance of the product.
• To influence the consumer to buy a product through visual perception.

6. FUTURE PROSPECT OF NATURAL FOOD COLOURS
• Microencapsulation:-
Increased light stability will be achieved with encapsulation of some sensitive
colours (annatto & paprika).
• Addition of antioxidants:-
To increased value of some food colours, external antioxidants tocopherols,
ascorbic acid & rosemary
• Emulsions:-
By formulating an easy to disperse colour emulsion to remain stable in many
different food application(gums or modified starches)
• Development of new sources:-
Extensive research should be done in introducing new colouring agent in the
market.

7. PHARMACEUTICAL PREPARATION ARE COLOURED FOR FOLLOWING
REASON
1)Increased acceptability:-
Unattractive medication can be made more acceptable to the patient by the use
of colour.
Colour can also be used to make a preparation more uniform when an
ingredient in the formulation has itself a variable appearance form batch to
batch.
2)For identification:-
It help to identify a product in it manufacturing & distribution stages.
The use of different colours for different strengths of the same drug can also
help eliminate errors.
3)Stability purpose:-
Some of the insoluble colours or pigment have the additional benefit when used
in tablet coatings or gelatin shells of providing useful opacity, which can
contribute to the stability of light sensitive active material in the tablet or
capsule formulation.

8. IDEAL PROPERTIES OF COLOURANTS
• Non-toxic & have no physiological activity.
• Free from harmful impurities.
• Is a definite chemical compound because then only its colouring power will be
reliable.
• Its tinctorial power should be high so that only small quantities are required.
• It does not interfere with the test & assays to which the preparation containing
it are subject.
• Free from objectionable taste & odor.
• Unaffected by light, tropical, temperature, hydrolysis & micro-organisms &
therefore, be stable on storage.
• Compatible with medicaments & not interfere with them.

9. PERMITTED NATURAL COLOURS
In India rule 26 of the prevention of food adulteration Act,1954(PFA) & the
prevention of food adulteration rules,1955 & 1999 permitted following colours
which are isolated form natural sources.
Beet root concentrates
Annatto
Beta-carotene
Colchineal extract
Grape extract
Paprika oleoresin
Turmeric oleoresin
Luetin
Phycocyanin
saffron

10. CLASSIFICATION OF COLOURANTS
A) ORGANIC DYES & THEIR LAKES:-
Dyes are synthetic, chemical compounds that exhibit their coloring power & tinctorial
strength when dissolved in a solvent. Eg- patent blue, erythrosine, sunset yellow, etc.
Lakes have been defined by FDA as the “aluminium salts of FD&C water soluble dyes
extended on a substractum of alumina”.
B)INORGANIC OR MINERAL COLOURS:-
Stability towards light is an important characteristic displayed by this material, some of
which have a useful opacifying capacity. Eg –titanium dioxide.
C)NATURAL COLOURS OR VEGETABLE & ANIMAL COLOURS:-
This is a chemically & physically diverse group of material. Natural colors are not as
stable to light as the other group of colors. They do, however,advantages in that they have
a wide acceptability. Eg-beta-carotene.

11. WIDELY USED COLOURANTS IN P’CEUTICALS
• FD&C Blue no.1 -Brilliant Blue,(blue shade)
• FD&C Blue no.2 -Indigotine,(indigo shade)
• FD&C Red no.3 - Erythrosine,(pink shade)
• FD&C Red no.4 - Allura red,(red shade)
• FD&C Yellow no.5 – Tatrazine ,(yellow shade)
• FD&C Yellow no.6 – Sunset yellow,(orange shade)

12. LIMITATIONS OF USING NATURAL FOOD COLOUR
• Some sources of natural colours have their own flavour which may affect the
taste of the finished product. (Turmeric)
• Actual colour may not retain as such when subjected to high
temperatures.(Grape juice extract)
• Can cause allergic reactions (Colchineal extract, annatto)
• Natural food colour are costlier than artificial colourings.(saffron)
• At times raw ingredients remains scarce.(Marigold extract)
• Require in large quantities when compared artificial dyes.(Colchineal extract)

13. THANK YOU