Organoleptic additives

Organoleptic additives promote appearance and palatability of pharmaceutical preparations.If the product does not having acceptable colour,odour, and taste the patient would try to avoid using it.There is a definite psychologic basis for drug therapy in which the colour, odour, and taste of pharmaceutical preparation can play their own part.

Following organoleptic additives are as follows :(1) Colouring Agents :Colourants are used to provide distinctive colour pleasing appearance or elegance to a dosage form.Colour helps the manufacturer to control the product during its preparation as well as serving as a means of identification to the user. Colourants may be soluble in the solvent system or suspended as insoluble powders.All colourants used in pharmaceutical must be approved and certified by FOOD DRUG AND ADMINISTRATION (FDA) and, FOOD DRUG AND COSMETIC ACT(FD&C).

Types of colouring agents are :(A) Natural Colour :y MINERAL COLOURS - Fequently termed as
pigments and are used to colour lotion,cosmetics and other prepration for external use. EXAMPLES:- red &yellow (ferric oxide) Lead chromate Titanium dioxide Carbon black

Titanium dioxideTitanium dioxide, also known as titanium (IV) oxide or titania, is the natural occurring oxide of titanium, chemical formula TiO2. In cosmetic and skin care products, titanium dioxide is used as a pigment and a thickener.Titanium dioxide is found in almost every sunscreen with a physical blocker because of its high refractive index, its strong UV light absorbing capabilities and its resistance to discolouration under ultraviolet light. Titanium reacts with oxygen to form a clear oxide TIO2.This clear oxides filter out light waves producing brilliant colour.As the thikness of oxide varies produce colour.

Ferric oxide (red & yellow)Iron Oxide is a unique natural mineral produced through beneficiation & fine grinding of our exclusive domestic ore body. Iron Oxide is light fast, chemically stable & color controlled within narrowly define parameters iron oxide formulations are used in manufacturing virtually all colored cosmetic and beauty products. Foundations, eye shadow, powder mineral pigments, lipstick,mascara, lip gloss, SPF products, facial powder, blush and pencil and liquid eye liners are just few of the products that use iron oxides as their primary coloring ingredient.

y PLANT COLOURS colouring principles from plants are normally obtained by extraction. EXAMPLES:-anthocyanin B-carotene Alizarin Indigo

IndigoIndigo obtained from plant Indigofera tinctoria. The color spectrum places indigo at 420 to 450nm.It means the color is between

blue and violet on the color scale. The color is considered one of the seven colors on the rainbow or optical spectrum. B-CaroteneCarotenoids are one of the most important groups of natural pigments. They are responsible for many of the yellow and orange colours of fruit and vegetables. Beta-carotene is most abundant in carrots, of course, but is also found in pumpkins, apricots and nectarines. Dark green vegetables such as spinach and broccoli are another good source. In these the orange colour is masked by the green colour of chlorophyll. This can be seen in leaves; in autumn, when the leaves die, the chlorophyll breaks down, and the yellow/red colours of the more stable carotenoids can be seen.

Reason to add isProtect body against oxidative damage Stimulate immune system Protect skin over uv light Safe dietry source of vitamin A

y ANIMAL COLOUR- as name suggest obtained from animal source. Tyrian Blue was obtained by oxidizing a colourless secretion from the gland of snails. Cochineal obtained from the insect coccus cacti contains the bright red colour carminic acid.

(B)

Synthetic Colours :-

The preparation of a colouring agents from coal tar were used & also used in food and bevarages to enhance their appearance without regards to their toxicity.It is mainly used today but they used under drug &cosmetic act and the following colours are :-

y Natural coloursEXAMPLE :-annatto Carotene Chlorophyll Redoxide of iron Titanium dioxide

y Artificial coloursExample:-caramel

CaramelCaramel Colour is the dark brown material that results from the carefully controlled heat treatment of food grade carbohydrates. It is also known as known as "burnt sugar colour."

y Coal for colours- They are a derivative of Petrochemicals and Coal tar. Colour Black Blue Red Green Yellow Orange common name napthal blue black brilliant blue amaranth alizarin cyanine green F tartrazine orange G

y Lakes- The alluminium or calcium salts of any of the water soluble colour.

Common Name

Color Index No.

19140 15985 14720 16255

Shade

Neelicol Tartrazine Neelicol Sunset Yellow FCF Neelicol Carmoisine Neelicol Ponceau 4R

Neelicol Brilliant Blue FCF 42090 Neelicol Indigo Carmine Neelicol Erythrosine Neelicol Fast Green FCF Neelicol Amaranth Neelicol Allura Red Neelicol Red 2G Neelicol Quinoline Yellow WS Neelicol Patent Blue V Neelicol Brown HT Neelicol Black PN Neelicol Green S 73015 45430 42053 16185 16035 18050 47005 42051 20285 28440 44090

Concentration of colours used areIn liquid prepration colourants added upto 0.0005 to 0.001% For powder 0.1%

Factors to be considered while selecting any colourant:(1) The certification of dye (2) Physical &chemical property of the dye (3) In case of liquid preprations the ph stability of the colour shoul tested. (4) Photostability of the dye (5) Personal preference of the consumer population

Precautions :In case of solid preparations

y Mottlingy

unequal distribution of colour.so to prevent it mixing should be done properly. When wet granulation is employed care should be taken to prevent colourmigration during drying.
of a tablet core without any visible disruption of the film coating. Temperature of

y Pitting-It is defect whereby pits occur in the surface

the tablet core is greater than the melting point of the materials used in the tablet formulation.

(2) Flavouring agent :Flavours or flavouring agents are usually required to mask the four basic taste sensations - Salty - bitter - sweet - Sour Flavouring is particularly significant in case of liquid dosage form intended for oral use.Chewable tablets of antacids, vitamins and antibiotic which are intended for mastication in the mouth are usually sweetened and flavoured to increase patients accepetance. Flavors oils are added to tablet granulation in solvents or are dispersed on clays and other absorbents or are immulsified in aqueous granulating agents.

Flavours according to their taste

Flavor Mint, vanilla, custard Lemon, orange Mint, fennel taste alkaline acid butter

Butter scotch,apricot Vanilla, honey, fruity

salty sweet

Flavours according to their colour

Flavor Chery, apple Chocolate, caramel Lemon Liquorice colour pink to red brown yello to orange blue

Mainly used volatile oil as flavor areClove, fennel, orange, wintergreen oil etc. And rose, jasmine, lavender etc provide floral smell to the preparations meant for external uses such as creams lotions. In recent time flavor are also marketed as spray dried powder

Storage of flavours :Temp- 15-300c Relative humidity range- 45%

Mainly 0.5 to 0.75% flavouring agent is used.

Factors should always be taken into consideration while selecting a flavouring agent:y Taste quality of the flavour. y The concentration of flavour, colour and sweetener. y Type of preparation whether for internal or external use y Age of patient y General liking and disliking of the intended user

(3) Sweetening agents

Sweetening agents are used to impart sweetness to a preparation. The four primary tastes are sweet, bitter, sour and saline and all other tastes are considered to be the admixture of one or more of these primary tastes in varying degrees.Mainly sweeteners are used to mark the bitter taste. And it must be dissolved, either when taken in solution form or dissolved in the saliva. It is used in the adjustement of taste in oral preparation because all drug for oral use may not be having aggriable taste and often the desaggreable taste is to be marked.

The following sweeteners are:a) Sucrose b) Liquid glucose c) Saccharin d) Cyclamates e) sorbitol f) Xylitol g) Dextrose h) Aspartame

a) Sugar/sucrose:Soluble in aqueous media and is available in highly purified form at reasonable cost. Physically and chemically stable at ph range 4-8. It s frequently used in conjugation with sorbitol, glycerin and other polyols which reduce the tendency of sucrose to crystalline

b) Liquied glucose:Prepared by partial hydrolysis of starch with strong acid.

c) Saccharin:It is an artificial sweetner and synthetic compound.And is 250 to 500 times sweet as sugar, but give a bitter after taste.And is reported to be carcinogenic. And is also available as saccharin sodium, saccharin calcium.

d) Cyclamates :- Cyclamates are normally sodium or

potassium salt of the cyclohexanesulphamic acid and now is banned because reported to cause cancer.

e) Aspartame:- Aspartame is the methyl ester of aspartic

acid and phenylalanine. And is less stable in moisture and hygroscopic in nature. And stable at ph 3.4 to 5.0.

Sweetening agent

Relavtive Sweeteness Compared to sucrose

Saccharin Sorbitol xylitol Dextrose Aspartame

500 tines 0.5 times 1 times 0.75 times 250times

Chief draw back with all sugers is their liability to microbial Growth