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Flavoring Agents in Pharmaceutical Formulations

Flavoring Agents

The flavor is the sensory impression of a food or other substance and is determined mainly by the chemical senses of taste and smell. UK Food Law defines a natural flavor as a flavoring substance (or flavoring substances) which is (or are) obtained, by physical, enzymatic or microbiological processes, from a material of vegetable or animal origin which material is either raw or has been subjected to a process normally used in preparing food for human consumption. The U.S. Code of Federal Regulations describes a “natural flavorant” as the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portions of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional.
Flavouring agents


1. Flavouring agents are particularly significant in the case of liquid dosage forms intended for oral use. by suitably flavoring the medication in a liquid dosage form, the disagreeable taste may be successfully masked.
2. Chewable tablets of antacids, vitamins, and antibiotics which are intended for mastication in the mouth, are usually sweetened and flavored to increase patient acceptance.

Classification of Flavoring Agents

1. Natural flavoring agent Flavoring substances obtained from plant or animal raw materials, by physical, microbiological or enzymatic processes. They can be either used in their natural state or processed for human consumption, but cannot contain any artificial flavoring substances.
Eg. Carbohydrates(honey), complex volatile oil (anise oil), aldehyde (vanillin), Aloe vera, Mentha, Cinnamomum, Eucalyptus, Ginger Oil, Natural Lemongrass oil, Peppermint Oil BP.

2. Natural identical flavoring agent Flavoring substances that are obtained by synthesis or isolated through chemical processes, which are chemically and organoleptically identical to flavoring substances naturally present in products intended for human consumption. They cannot contain any artificial flavoring substances.
Eg. Methyl salicylate, alcohol, glycerin.

3. Artificial flavoring agents Flavoring substances not identified in a natural product intended for human consumption. These are typically produced by fractional distillation and additional chemical manipulation of naturally sourced chemicals, crude oil or coal tar. Although they are chemically different, sensory characteristics are the same as natural ones.
Eg.cinnamaldehyde and benzaldehyde

Most Common Flavors

Taste - Masking Flavor
Salty- cinnamon, raspberry, orange, maple, butterscotch, glycyrrhiza (licorice) syrup
Sweet- fruit, berry, vanilla, acacia syrup
Bitter- cocoa, chocolate-mint, wild cherry, walnut, glycyrrhiza (licorice), Eriodictyon, raspberry syrup
Sour- fruit, citrus, cherry syrup

Widely used Flavoring Agents in the Pharmaceutical Formulations

1.Caramel, Cocoa Powder – Food Colours & Flavors, used in pharmaceuticals, confectionery, ice creams, soft drinks, and all other kinds of food products.
2.Mentha Arvensis oil
3.P-Anisic Acid- 4-Anisic Acid; 4-methoxy benzoic acid – used as Flavoring Agent; Fragrance Ingredient; masking. as a pharmaceutical intermediate.
4. Peppermint Oil BP- Peppermint Oil BP is an Active Pharmaceutical Ingredient, classified as Herbal drug, widely used in the pharmaceutical industry.
5.L-Ethyl Lactate-Use As food aromatizing agent, flavoring agent of wines, and as a pharmaceutical intermediate.
6. GMP certified menthol- GMP Certified Menthol Crystals IP/EP/BP/USP are made under rigid Pharmaceutical standards having all the regulatory approvals.
7. Dill Seed Oil
8. Fennel oil Indian-Natural
9. Caraway Oil Indian IP/BP/EP/USP/FCC/Food Grade
10.Soya Bean Oil BP/EP/USP/FCC

Novel Flavoring Agents

(a) Sodium gluconate-high quality, best price, and purity more than 99.5%.
(b) L-Theanine.
(c) Methylene chloride

Recommended Reading -

List of Pharmaceutical Excipients/Additives and Their Uses Enlisted