Q1.

Explain With classification and advantage, disadvantage

i. Flavouring agent
ii. Colouring agent
iii. Sweetening agent
iv. Preservatives

Ans.
FLAVOURING AGENTS
• Flavouring agents play a vital role in masking the Flavours/Flavouring Agents
disagreeable taste of liquid dosage forms used for oral oral purposes.
• In order to increase the patient compliance, certain antibiotics masticated in the mouth
and chewable tablets of antacids are generally sweetened and added with flavouring
agent.
Suitable Masking Flavours For Various Product Tastes

Taste of Product Suitable Masking Flavour

Salty Apricot,Butterscotch,vanilla,

Bitter Chocolate, Wild cherry,

Sweet Vanilla, Fruits, Berries

Sour Citrus Fruit, Raspberry

Selection Criteria
• The qualities of the taste of flavour.
• Suitability of the combination of flavour, colour and sweetener.
• Type of the preparation, whether for internal or external use.
• Patient's age.
 • General liking and disliking of the intended users.
• Best flavour for a particular product is usually selected by forming a panel and by the
consent of majority.
Advantages
• The unpleasant taste of the medicament is masked by the flavouring agents.
• These agents help in increasing patient compliance for tablets that are chewable.
Disadvantages
• There are certain intolerable flavours that cannot be masked, e.g., in case of mal
which is initially sweet, then astringent and finally bitter in taste.
• The formulations meant for patients on reducing diets or diabetics do not contain the
sweetening agents that increase calories or blood sugar levels.
Uses
• Flavouring agents aids in masking the disagreeable odour or taste of the medications
so as to increase the patient's acceptance towards the drug.
• They induce an acceptable flavour in the medicament.
Colours/Colouring Agents
• In pharmacy, the colourants or colouring agents obtained from plants, animals,
mineral sources are particularly used for the purpose of providing colour so as to
impart pleasing appearance to the drugs and cosmetics.
• They are also used as colouring agents in the foods and for other psychological
effects.
Some of the colouring agents or colourants are given below:
1) Mineral Colours: These are used to colour cosmetics, lotions, and other preparations for
external use, e.g, red and yellow ferric oxides, titanium dioxide, Prussian blue, etc. Mineral
generally called pigments.
2) Plant Colours: These colours are generally obtained by extraction from plants, e.g.,
chlorophyll, B-carotene, alizarin, indigo, anthocyanin and flavones.
3) Animal Colours: Carminic acid, a bright red in colour obtained from the insect Coccus
cacti. These are also used as synthetic colorants.
4) Synthetic Colours: In the early days, aniline was used for the preparation of synthetic
colours.
Since, all the synthetic colours are not fit for human consumption; therefore, governments of
different countries have approved only some specific colours to be used in the preparations.
The qualities of the taste of flavour.
• Suitability of the combination of flavour, colour and sweetener.
• Type of the preparation, whether for internal or external use.
• General liking and disliking of the intended users.
 The Drugs and Cosmetics Act 1940 and Rules 1945, in India have permitted the use of the
following colours in drugs:
1) Coal Tar Colours: Amaranth, green S, orange G, patent blue and tartrazine.
2) Lakes: Lakes are the aluminium or calcium salts of any water-soluble food dye.
Classification:

Coloring agent

Natural colour Synthetic colour

Eg:
Minerals
Animals Plants
Coal tar: amaranth, green s
Eg:
Eg. Eg:
Coccuscati Ferric Lakes: aluminium or calcium
, carmanic Alizarin, oxide, salts
acid indigo titanium
dioxide

Selection Criteria
• The certification status and the aesthetics of a dye.
• The physicochemical properties of the dye.
• pH and pH stability of the liquid preparations.
• The dye must be photo stabilised.
• Personal preference of the consumer population.
Advantages
• They provide grace and better eye
• For the effective treatment of poisoning in the early stage, colours play an important
role in the fast recognition of the medicine.
• Different colours of the medicines can also help the patient during previous treatment.
• Doctors become familiar with the colour of the products and this helps in the sale of the
medicine.
Disadvantages
• The colouring property was not much elegant.
• They do not show their lasting effect in solutions.
• Sometimes the effect of sunlight fades the colour of coal tar.
 • Many colours behave as feeble indicators and alteration in pH may be accompanied by
the changes in colour and tinctorial power.
Uses
• For Identification
• To Increase their Acceptability to Patients
• To Give Warning
• To product Standard Preparation
Sweeteners/Sweetening Agents
• Sweetening agents are the constituents that are added to a drug preparation to mask its
bitter taste. The most widely used natural sweetening agent is sugar.
• It gives viscosity to drug and also acts as preservative for liquid dosage form. There are
two varieties of substitutes which are used as sweeteners:
1. Natural sweeteners
2. Artificial sweeteners
Classification On the basis of Nutritive value

Selection Criteria
• Sweeteners provide a substitute to sugar without the related energy (kilojoules), for
those who mainly have sweet tooth.
• There are various ways by which sweeteners can be added into the diet and the
sweetener is selected on the basis of requirement.
• An artificial or table top sweetener can be used in case an individual is resisting
sweetness in a cup of tea or coffee.
• In case of stability of the sweeteners, a natural intense sweetener is preferred over other
sweeteners as they are more heat stable.
Advantages
 • Weight Control: An artificial sweetening agent should be used, in case; someone wants
to reduce their weight as it contains zero calories. Whereas, one gram of sugar contains
4 calories and one teaspoon of sugar contains about 4 grams of sugar, 16 calories per
teaspoon.
• Diabetes: It also assists in monitoring diabetes as it does not increase the blood sugar
levels due to absence of carbohydrates in it.
Disadvantages
• They can cause dental cavities, raised blood sugar, calories.
• They increase the risk of cancer and may destroy blood sugar and intestinal health.
• They may result in weight gain and poor nutrition.
Uses
• Saccharine can be utilised to sweeten candies, drinks, and toothpaste.
• Lactose is an additive and filler found in various products to maintain structure and
consistency.
• Sorbitol is mainly used as a laxative to relieve constipation.
Preservatives
• A preservative is a natural or synthetic substance that is added in the products like foods,
pharmaceuticals, paints, biological samples, wood, etc., to avoid decomposition by
microbial growth or by unwanted chemical changes.
• These are chemicals that are commonly added to many foods and pharmaceutical
products in order to extend their shelf life.
• Preservatives are added especially, to the products having greater water content to
prevent them from alteration and degradation by microorganisms while storing
• Preservatives are added in foods to prevent growth of bacteria, yeasts, or molds that
may cause a disease.
Ideal Properties of Preservatives
• It should be non-irritant.
• It should be non-toxic.
• It should have physical and chemical stability.
• It should be compatible with other ingredients added in formulation.
• It should be a good antimicrobial agent and should exert wide range of activities.
Classification
On the Basis of Mechanism of Action
1. Antioxidants e.g. Vitamin C, Vitamin E, BHA Butylated hydroxy anisole
2. Antimicrobials e.g. benzoates, sorbates
3. Chelating agents e.g. citric acid, polyphosphates
Based on source:
1. Natural preservatives e.g. neem oil, lemon, honey.
 2. Artificial e.g. benzoates, nitrates, propionates
Selection Criteria
• It should be stable and highly effective even in small concentrations.
• It should not react with other ingredients of the product to form any harmful substance.
• It must be easily soluble in the desired vehicle.
• It should be odourless, tasteless, and colourless.
• The physicochemical properties of the preservative should not get affected by the pH.
• It should not produce any sensitising effects. toxic, irritant
Advantages
• They help in maintaining the consistency with the texture and provide thickness.
• They also increase the appearance of the product to make it look edible and safe to
consume for a respectable amount of time.
Disadvantages
• A group of preservatives used in fruit drinks, tea and coffee are benzoates that cause
allergic reactions, asthma attacks, skin rashes, and is considered to cause brain damage.
Uses
• Preservatives are added to food to fight spoilage caused by bacteria, molds, fungus and
yeast.
• Preservatives can keep food fresher for longer periods of time, extending its shelf life.
• Food preservatives also are used to slow or prevent changes in color, flavor or texture
and delay rancidity.
PHARMACEUTICAL AIDS
The elements having little or no therapeutic value, but are basically used in production or
compounding of various pharmaceuticals, are known as pharmaceutical aids or pharmaceutical
necessities.
The functions of pharmaceutical aids in pharmaceutical dosage form are:
• They also modify the API's solubility and bioavailability.
• They also help the APls to maintain their polymorphic forms or conformations.
• They help the liquid dosage forms in maintaining their pH or osmolarity.
• They prevent aggregation or dissociation (e.g. of protiens and polysaccharide actives).
• They modulate the APIs immunogenic responses (eg., adjuvants).
• They make up the bulk of a potent drug formulation to obtain an accurate dosage form.
• They improve the patient compliance.
They modify the formulation's safety and effectiveness during its use and storage
period.
Ideal Properties
• Non-reactive and inert,
• Chemically stable,
• Non-toxic,
 • Requires less equipment and process
• Acceptable organoleptically
• Economical.
Classification
On the basis of their origin, dosage forms and functions
Based on their Origin
• Animal Source: Lactose, Gelatin, Stearic acid, Bees wax, Honey, Musk, Lanolin, etc.
• Vegetable Source: Starch, Peppermint, Turmeric, Guar gum, Arginates, Acacia, etc.
• Mineral Source: Calcium phosphate, Silica, Talc, Calamine, Asbestos, Kaolin,
Paraffin, etc.
• Synthetic Source: Boric acid, Saccharin, Lactic acid, Polyethylene glycols
• Povidone, etc.
Based on Dosage Forms
• Solid dosage forms (tablets, capsules, etc.),
• liquid dosage forms (solutions, syrups, etc.),
• semi-solid dosage forms (ointments, pastes, etc.)
• utilise excipients, therefore, they have been also classified based on the differ in which
they are used.

Pharmaceutical Aids Used in Liquid Dosage Form

Category Examples
Solvent Water, alcohol
Co- solvent Ethanol, sorbitol
Buffers Phosphate buffer
Antimicrobial preservatives Benzyl alcohol
Antioxidants Ascorbic acid
Antifoaming agent Paraffin oil, alcohals
Chelating agents Citric acid and tartaric acid
Emulsifying agent Sorbitol esters
Flocculating agent Starch, carbomer
 Pharmaceutical Aids Used in Liquid Dosage Form
Category Example
Preservative Benzyl alcohol
Solubilisers Lanolin, cholesterol
Gelling agent Pemulen, cellulose
Suppository base Glycerine, coconut oil