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CHAPTER 3
PHARMACEUTICAL
AIDS
CHAPTER 3
PHARMACEUTICAL
AIDS
Presented by:
Sharib Jamal
Associate Professor
PHARMACEUTICALAIDS
 Some inorganic and organic chemicals don't have any therapeutic value but are
basically used in manufacturing of various pharmaceuticals are known as
pharmaceutical aids.
 Pharmaceutical aids helps in masking the unpleasant odor, taste and flavor of any
dosage form.
Classification:
 Antioxidants
 Buffering agents
 Colouring agents
 Disintegrating agents
 Emulsifying agents
 Flavouring agents
 Preservatives
 Sweetening agents
Importance / Application of Pharmaceutical Aids
 It helps in masking the unpleasant odor, taste and color etc.
 Pharmaceutical aids increase the shelf life of the drugs.
 It protects the chemical change and microbial action of main API.
 They include antibacterial agents and antioxidants.
 They improve the patient compliance.
 They enhance API’s bioavailability.
Ideal Characteristics of Pharmaceutical Aids
 Non reactive and inert
 Non-toxic
 Chemically stable
 Cheap and easily available
 Efficient with respect to its use
 Does not change chemical nature of the drug.
ORGANOLEPTIC AGENTS
 These agents are the important agents of pharmaceutical aids.
 These agents include colouring , flavouring, and sweetening agent
COLOURING AGENTS
 Colouring agents are mainly used to improve the appearance of pharmaceutical
dosage form.
 These agents helps in the identification during manufacturing and increase the
patient acceptance towards the pharmaceutical dosage form.
 In pediatric and geriatrics, coloring agents play a major role and attract the
consumer by providing the aesthetic appearance to dosage form.
 All colouring agents used in pharmaceutical formulations must be approved and
certified by FDA as per D&C Act 1940.
Types of colouring agents
A. Natural Colours: They are obtained from animals, plants and minerals.
1. Animal Colours: They are obtained from animal sources. Example: Tyrian
Blue, Carminic acid etc.
2. Plant Colours: These are obtained through extraction. Example: indigo,
carotenoids, chlorophyll.
3. Minerals: These are pigments used in cosmetics, lotions. Example: Titanium
dioxide, yellow and red iron oxides
B. Synthetic colours: These enhance the appearance of pharmaceutical
product without being toxic.
Example: Coal tar dyes, caramel and lake dyes.
Uses/applications of colouring agent:
 Colouring agents provide the suitable colour to formulation and
helps in the identification.
 Increase the consumer acceptance.
FLAVOURING AGENTS
 Flavourants or flavouring agents are mainly used for masking the unpleasant or
unacceptable odour from formulation and provide more pleasant taste or flavour.
 There are four basic taste sensations; salty, sweet, bitter and sour.
 Flavour added to drug solutions can make a medicine more acceptable to take
especially if the drug has an unpleasant taste.
 In the pediatric dosage form flavour play a key role for administration of the drugs.
Classification of flavouring agents:
1. Natural flavouring agents: citrus fruit (lemon, orange) spice (cinnamon,
peppermint, ginger, onion), fruits(apple, banana)
2. Synthetic flavouring agents: Benzaldehyde, cinnamic aldehyde, coumarin, ethyl
methyl ketone, vanillin.
Uses /applications of flavouring agents:
 Masking the unpleasant taste or flavour and provide suitable flavour
 Increases the consumer acceptance.
SWEETENING AGENT
 Sweetening agent are used to impart sweet taste to the bitter
pharmaceutical formulation.
 In pediatric dosage form its is widely used because children prefer more
the sweetening drugs.
 Sugar is most widely used sweetening agent. Due to its viscosity nature
it is also used as preservative for liquid preparation.
Classification of sweetening agents
1. Natural sweetening agent: Glucose, Fructose, Sucrose, Dextrose,
Sorbitol, Mannitol.
2. Artificial sweetening agent: Sucralose, Aspartame, Saccharin.
Uses/applications of sweetening agents:
 Sweetening agent masking the undesirable or bitter taste.
 Increase the consumer acceptance.
PRESERVATIVES
 A preservative is a natural or synthetic substance commonly added to
various food and pharmaceuticals product in order to prolong their shelf
life, to prevent decomposition by microbial growth or by undesirable
chemical change.
Ideal properties of preservatives:
1) It should be non-irritant.
2) It should be non-toxic.
3) It should have physical and chemical stability.
4) It should be a good anti-microbial agent.
5) It should act as preservative in minor concentration.
Classification of Preservatives
A. Based On Mechanism Of Action:
a) Antioxidants: The agent which prevent oxidation of API which
otherwise undergo degradation due to oxidation as they are
sensitive to oxygen. For example: vitamin A, Vitamin C,
Butylatedhydroxyanisole (BHA) , Butylatedhydroxytolune
(BHT).
b) Antimicrobial Agents: The agent which are active against gram
positive and gram negative microorganism. For example:
Benzoates, Sodium benzoate, sorbates.
c) Chelating agents: these are the agents that form complex with
pharmaceutical ingredient. For example: Disodium
ethylenediamine tetra acetic acid (EDTA), Citric acid,
Polyphosphates.
B. Based On Source:
1. Natural Preservatives: These drugs are obtained by natural sources
that is plant, mineral sources, animal etc. For Example: Neem oil,
salt, lemon, honey etc.
2. Artificial preservatives: These preservatives are man made by
chemical synthesis active against various micro-organisms in small
concentration. For example: benzoates, sodium benzoates, sorbates,
nitrites etc.
Uses and benefits of preservatives:
1. Preservatives in food: Preservatives prevent the bacteria, fungus, yeast and
mould to grow and multiply in food and spoiling it.
2. Preservatives in medicine and pharmaceuticals: some preservative are used
to prevent the microbial contamination of some medicines like insulin and
cough syrups.
3. Preservatives in cosmetics and personal care products: preservatives are
added in cosmetics like sunscreens, lotions, shampoos, cleansers, toothpaste and
makeup to prevent growth of harmful bacteria.
4. Antimicrobial preservatives: help to prevent the growth of moulds, yeast and
bacteria.
5. Preservatives in wood: wood treated with preservatives can be used to build
road signs, as well as decks and play structure.
6. Environmental factors: many environmental factors affect the products
property, for overcoming this activity, preservatives are used.
Examples: Alpha tocopherol, Benzoic acid, Sodium benzoate, Para hydroxy
benzoates, Ascorbic acid, Salicylic acid, Methyl paraben, Sodium chloride,
Phenol, etc.