MIND NURTURE KRISHNA Page 1 of 4

PHARMACEUTICAL AIDS
• Pharmaceutical aids are the substances which have no or little pharmacological effect but they are
essentially used in the preparation of pharmaceutical dosage form (like tablet, injection, emulsion,
ointments etc).
• Pharmaceutical aids used as preservations, stabilization, acidification, alkalization, suspending, excipient,
adsorption, absorption, filtration, prevention of oxidation, stabilization, complexation etc.
• Pharmaceutical aids may remain in the final product in which case they do not exert any specific action on
the body when the product is administrated or they may get removed during processing but come in close
contact with the product at some stage.
• Many times pharmaceutical aids are referred to as “pharmaceutical necessities”. It is essential that
pharmaceutical aids should be of same quality as therapeutic agent and are subject to similar quality
controls.
• Various pharmaceutical aids are classified into various categories which are given as follows:
➢ Classification based on their origin
i) Animal source: ex- lactose, gelatine, bees wax, lanolin etc
ii) Vegetable source: starch, peppermint, turmeric, guar gum etc
iii) Mineral source: calcium phosphate, silica, asbestos, kaolin etc
iv) Synthetic source: povidone, boric acid, polyethylene glycol
➢ Classification based on dosage form
1. Acidifiers and alkalisers.
2. Buffers- maintain pH of formulation
3. Absorbents and adsorbents.
4. Antioxidants and preservatives. (In syllabus )
5. Desiccants-
6. Suspending agents-
7. Colorants.
8. Tonicity adjusting agents(osmolority)-
9. Solvent and vehicle-
10. Organoleptic agent: Coloring, flavoring and sweetening agents. (In syllabus)
11. Ointments and suppository bases.
12. Diluents
13. Binders
14. Disintegrating agents
15. Lubricants

1. Colouring Agents:
• The colouring agents are used in the dosage forms to improve the attractiveness of the product.
• Colouring agents also useful in distribution & product identification, particularly in poisonous
materials.
• Colouring agent imparts colour to dosage form.
• Colorant has no direct therapeutic effect but has psychological effect.
There are three sources of colour, namely mineral, plant, animal and synthetic.
1) Mineral colours
• Only used for externally applied preparation
• Includes ferric oxides red and yellow, carbon black, lead chromate, Prussian blue, TiO2.
2). Plants
• Colour source from plants includes
o Flavones: Rutin, Riboflavins, hesperidine, Quercetin, beta-carotene- Yellow color
o Saffron & Alizarin-redish yellow
o Others-Alizarin, anthocynin, chlorophyll, carotenoids etc
o Indigo dye from Indigofera tinctoria
3) Animal Source
• Tyrian blue (from glands of snails).
• Cochineal, an insect (Coccus cacti) containing a bright red color, carmine acid.
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4. Synthetic colors
• Example- Caramel, Coal tar dyes, Lake dyes
• Categorized into three categories as per FDA (US)
i) Color permitted for Food, Drugs & Cosmetics (FD&C)
ii) Color permitted for Drugs & Cosmetics (D&C)
iii) Color permitted for externally applied Drugs & Cosmetics (external D&C)

i) Soluble Dye-
• Derived from Petrochemicals
• Exhibit colour by transmitted light
• Water soluble dye
• Coal tar colours(aromatic hydrocarbon): Naphthol blue black, brilliant blue, resorcin brown,
sunset yellow, tartrazine, amaranth, green S, orange G. Commonly used in medicated shampoos,
soap, ointment etc
ii) Lake Pigments-
• A lake color or lake pigment is basically insoluble in nature and colors through dispersion.
• Lakes are produced through precipitation of soluble dyes with some metallic salt(Al and Ca).
• Insoluble in water (so choice for oils, fats & Lipid formulations)
• Only Alumina lake permitted for use in FDC
iii) Caramel- it is a dark brown material, obtained from thermal application on carbohydrate. It is also
called burnt sugar.
➢ Certified colorants
• All colouring agents used in pharmaceutical formulations must be approved and certified by FDA as
per drug and cosmetic act 1940

2. Flavoring agents
• The Flavouring agents are included to improve the taste of the product either by providing a more
pleasant taste or by masking the unpleasant taste i.e (make medicine palatable)
• Flavoring Agents: Aroma molecules (produce flavor) + Carrier
• Flavoring agents may be classified aa
i) Natural (N)
ii) Artificial (A)
iii) Natural & Artificial (N&A)

i) Natural (N)flavoring agents

• Prepared from extraction (distillation, extrusion & solvent extraction)
• Drawback- Natural flavoring agent- unstable
• Example:
→ Citrus oils: most stable
→ Anise (Pimpinella anisum, Umbelliferae)
→ Cardamon (Elettaria cardamomum, Zingiberaceae)
→ Wild Cherry (Prunus serotina, Rosaceae)
→ Lemon (Citrus limonum, Rutaceae)
→ Orange, Bitter (Citrus aurantium, Rutaceae)
→ Orange, Sweet (Citrus sinensis, var. aurantium dulcis, Rutaceae)
→ Peppermint (Mentha piperita, Labiatae)

ii) Artificial Flavours

• Mixtures of synthesized aroma chemicals that may be identical to natural flavours.
• Artificial flavours are usually stable, have greater consistency and decreased impact
from raw material changes.
• The flavours for pharmaceutical products consisted of volatile oils like anise, clove,
fennel, lemon, orange, winter green oils or of their separated fractions such as menthol,
thymol, camphor etc.
• Example- benzaldehyde, cinnamic aldehyde, coumarin, ethyl, methyl ketone .
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iii) Natural and Artificial Flavours

• Natural and Artificial Flavours system in which Natural flavours are combined with artificial
flavours to enhance flavour balance and fullness.
Flavour Enhancers and Potentiators
• These are most often employed to enhance flavour.
• These includes
o Sugar, carboxylic acids-citric acid, malic acid, and tartaric acid)
o common salt (NaCl)
o amino acids, amino acid derivatives (e.g. mono-sodium glutamate-MSG),
o Spices (e.g. peppers)
o Monoammonium glycyrrhizinate

3. Sweetening agents
• Taste is again a chemical sense and its appreciation results from the contact between the taste
possessing materials and the taste buds in the oral cavity.
• Four primary tastes sweet, bitter, sour, saline are recognized and all the other tastes are considered
to be admixtures of one or more fundamental tastes in varying degrees.
• Sweeteners are often classified as either caloric or noncaloric. Non-caloric sweetening agents are
preferred for diabetic patients, .
Sweetening Agents Agents
Sucrose/table sugar
Caloric (contraindicated in Diabetic
Fructose
patients)
D-Glucose
Saccharine (500 times sweeter than sucrose; unpleasant after
taste)
Aspartame (200 times sweeter than sucrose; unstable in
solution)
Non-caloric (Sugar free sweeteners)
Acesulfame-K (200 times sweeter than sucrose; Heat stable)
Cyclamate/Na. cyclamate (30 times sweeter than sucrose)
Sorbitol (polyols)
Sucralose (600 times sweeter than sucrose)
• The commonly used sweeteners in the pharmaceutical industry are sucrose (sugar), glucose, fructose,
sorbitol, and glycerin.
• Mannitol- chewable tablet manufacture-Less hygroscopic.
➢ Sugars
• Sugars such as cane sugar, glucose with or without complimentary compounds like sorbitol, glycerin etc.
have been used as sweetening agents from the very beginning.
• Sugar coating was an ancient technique and simple syrup has been used as vehicle for many oral
preparations. Sugar often comprise of appreciable portions of solid dosage forms such as tablets.
• Cane sugar is stable between pH 4-8 and is generally used along with glycerin or sorbitol which reduces
its tendency to get crystallized. Liquid glucose, prepared by partial hydrolysis of starch is also very
suitable for sweetening of liquid preparations.
• Chief drawback with all sugars is their liability to microbial growths.
• Sugars such as lactose and maltose, have very limited sweetening power and as such the same are
required to be used in large amounts.
• Sucrose, a low molecular weight carbohydrate, has been traditionally used as sweetening agent because
of several advantages associated with it: very soluble in water, stable over a pH range of 4 to 8, increases
viscosity which impart a product a pleasant texture in the mouth.
• Sucrose: Can not use in diabetic patients
• Polyhydric alcohols: sorbitol, mannitol, and to some extent glycerine have sweetening properties and
can be used in preparations for diabetic patients
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➢ Artificial sweeteners
Artificial sweeteners are used in very small amounts of these substances can make formulations appreciably
sweet. Artificial sweeteners includes
i) Saccharin
ii) Aspartame
iii) cyclamates
iv) Acesulphame-K
v) Acesulphame
i) Saccharin
• Saccharin is marketed as saccharin sodium in which the hydrogen in –NH group is replaced by Na and which
in the crystalline form also has two molecules of water of crystallization. Sodium saccharine can be easily
prepared by dissolving saccharin in equimolecular quantities of aqueous sodium hydroxide solution followed
by crystallization. Sodium saccharin is nearly 200 times more soluble in water in comparison to saccharin.
• Saccharin is nearly 450-500 times sweeter
• Saccharin does not undergo metabolism and its potential for causing cancer is determining factor for its
use(carcinogen due to cyclohexylamine formation, possibly by gut)
• bitter aftertaste
Aspartame
• 200 times sweeter than sucrose
• Aspartame undergoes metabolism producing phenylalanine and the phenylalanine metabolism is a problem
in persons with phenylketonuria
Cyclamate/ Sodium cyclamate
• 30 times as sweet as sugar
• carcinogenic so banned in USA
• no aftertaste
Sucralose
• 600 times sweeter than sucrose
Acesulphame
• approximately 200 times sweeter than sucrose
Monoammonium glycyrrhizinate
• Monoammonium glycyrrhizinate used in liquid oral preparations

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