Basics of Pharmaceutical ScienceS

Assignment 3
Name: Ponnuru Greeshmanth
SAP ID: 500097541

Branch: BTech Chemical

Roll No: R900221034

1.Preservatives:

Definition:
Preservatives are substances or chemicals that are added to a variety of items,
including food, drinks, phamaceuticals, paints, biological samples, cosmetics, wood,
and many others, to stop the microbial development or unfavourable chemical
changes that lead to decomposition.

Types of preservatives are Acidic, Neutral, Mercurial, Ammonium etc.

Preservative capacity is a term used to describe the cumulative level of
contamination that a preserved formulation can tolerate before becoming so

depleted as to become ineffective.

Preservatives are substances that commonly added to various foods and
pharmaceutical products in order to prolong their shelf life. The addition of
is
preservatives to such products, especially to those that have higher water content,
essential for avoiding alteration and degradation by microorganisms during storage.
The British pharmacopoeia (BP) stated that the addition of antimicrobial

preservatives to radio-pharmaceutical preparations in multi dose containers is not

their addition is prescribed in the monograph.
obligatory unless
The addition of preservatives to products, especially to those that have higher water
content, is essential for avoiding alteration and degradation by microorganisms
during storage. Preservatives are put in foods to inhibit growth of bacteria, yeasts,
or

moulds that can cause disease. Chemical preservation cannot totally keep products
from spoiling, but they slow the spoiling process caused by microorganisms. Frozen
and canned foods often do not contain any preservatives. Processed Foods are
foods that are put through a process to kill harmful bacteria that may form in the
food. These processes are supposed to be helpful to the products, but they can also
add harmful substances.
PropertiesS
1. It must be effective against broad spectrum.
2. It should not be toxic and irritating.
3. It should be physically and chemically stable.
4. It should be compatible with other ingredients used in formulation.
5. It should be act as good antimicrobial agent and should exert wide spectrum of
activity.
6. It should act as preservative in small concentration i.e., it must be potent.
7. It should maintain activity throughout product manufacturing, shelf life and usage.

Usage:
Name of Preservative Concentration Recommended
in %)
1. Phenol 0.065-0.2
2. Chlorobutanol 0.25-0.5
3. Benzoic Acid 0.1-0.3
4. Boric Acid 0.5-1
5. Sorbic Acid 0.05-0.2
6. Benzyl Alcohol 0.5-10
7. Methyl Paraben 0.25
8. Bronidol 0.001-0.05
9. Sodium Benzoate 0.1-0.2
10. Chlorocresol 0.05-0.1
 2. Sweetening Agents:

Definition:
Sweetening agents are excipients often added to pharmaceutical dosage forms
to mask bitter taste of the partially dissolved drug and to improve palatability in

general. Traditionally, oral formulatilons wore swoetened using concentrated sucrose

solution (syrup) or honey (contains fructose)
Sweeteners are defined as food additives that are used or intended to be used either
to impart a sweet taste to food or as a tabletop sweetener. Tabletop sweeteners are

products that consist of, or include, any permitted sweeteners and are intended for
sale to the ultimate consumer, normally for use as an alternative to sugar. Foods
with sweetening properties, such as sugar and honey, are not additives and are
excluded from the scope of official regulations. Sweeteners are classified as either
high intensity or bulk. High-intensity sweeteners possess a sweet taste, but are
noncalonc, provide essentially no bulk to food, have greater sweetness than sugar,
and are therefore used at very low levels. On the other hand, bulk sweeteners are

generally carbohydrates, providing energy (calories) and bulk to food. These have a

similar sweetness to sugar and are used at comparable levels.

PropertiesS
1. Be effective even at small concentrations.
2. Must be stable at wide range of temperature.
3. Should not lead to any diseased situation.

4. Should have low or n-calorific value.

5. Should be compatible with other ingredients.
6. Should not show batch to batch variations.

7. Should be readily available and inexpensive

 Usage:
Name of Sweetener Recommended Concentration (%) like
1. Acesulfame Sweetening power is approximate 180-200 times that of sucrose,
Potasslum aspartame.
2. Alitame Approximately 2000 times sweeter than sucrose.
It is
3. Aspartame Sweetening power is Approximate 180-200 times that of sucrose.
a dipeptide sweetener.
to
4. Dextrose It is simple sugar that is made from corn and chemically similar
glucose.
5. Erythritol Use as Sweetening agent at concentration 0.5-3.0%
6. Fructose Fructose is 50% sweeter than ordinary sugar.
It is a simple sugar and most abundant monosaccharide.
7.Glucose
8. Lactitol Also, It is used as a laxative and is used to treat
or preventconstipation.
9. Maltitol As sweet as sucrose.
10. Maltose A dextrodisaccharide from malt and starch.
11.Mannitol Itis like xylitol or sorbitol.
sweeter than and 20 times
12. Neo hesperidin Approximately 1500-1800 times sucrose

Dihydrochalcone sweeter than saccharin.

sweeter
13. Neotame Structurally related to aspartame and is about 30--60 times
than aspartame and 7000-13000 times sweeterthan sucrose.300-600
14. Saccharin It is used at a concentration of 0.02-0.5% w/w Approximately
times sweeterthan sucrose.
the
15. Sodium Cyclamate | In dilute solution, up to about 0.17% w/v, approximately
sweetening power is 30 times than sucrose. Sodium cyclamate is
10: 1.
used in combination with saccharin, often in a ratio ofsucrose. It
It is a polyhydric alcohol with about 1/2 sweetness of
16. Sorbitol synthetically.
OCCurs naturally and also produced from glucose
300-1000 times that of
It has sweetening power
17.Sucralose Approximately a

SUcrose and has no aftertaste.

18.Sucrose Use as Sweetening agent at concentration 67%
10-50%
19. Compressible Sweetener in chewable tablets at concentration
Sugar
20. Confectioner's Sweetening agent in tablets at concentration 10-20%
Sugar sweet as 10% sucrose
21. Tagatose 10% solution of tagatose is about 92% as a

Solution.
It is a naturally occurring intense sweetening agent approximately
22. Thaumatin 2000-3000 times as sweet as sucrose.
23. Xylitol It prevents production of acids by oral bacteria that damage the teeth
surfaces.
 3. Flavouring Agents:

Definition: of varieties like fruit, nut,

food additives with hundreds
Flavounng agents key
are
natural flavouring agents.
vegetables and wine which are
seafood, spice blends, natural flavours.
are chemical
flavours that imitate
Besides natural flavours there have a bitter and
are alcohols that
chemical flavouring agents flavours to caramel,
Some examples of
ketones and pyrazines provide
medicinal taste, esters
are fruity, flavour.
terpenoids have citrus or pine
flavour and
phenolics have a smoky determined
substance and is
impression of a food or other
The flavour is the sensory Law defines a natural
and smell. UK Food
chemical s e n s e s of taste
mainly by the which is (or are)
flavouring substances)
flavour flavouring substance (or
as a
processes, from
a material of
enzymatic or microbiological
obtained, by physical, has been subjected to
a
which material is either raw or
vegetable or animal origin The U.S. Code of
used in preparing food for human consumption.
process normally oleoresin,
flavourant" as the essential oil,
describes a "natural
Federal Regulations of roasting,
distillate, or any product
essence orextractive, protein hydrolysate, constituents derived from a
enzymolysis, which contains the flavouring
heating or
edible yeast, herb, bark, bud,
vegetable or vegetable juice,
spice, fruit or fruit juice, meat, seafood, poultry, eggs, dairy
leaf other edible portions of a plant,
root, or any function in food is
thereof, whose primary
products, or fermentation products
nutritional.
flavouring rather than

PropertiesS forms
1. Flavouring agents are particularly
significant in the case of liquid dosage
the medication in a liquid dosage form,
intended for oral use. by suitably flavouring
the disagreeable taste may
be successfully masked.
are intended for
2. Chewable tablets of antacids,
vitamins, and antibiotics which
sweetened and flavoured to increase patient
mastication in the mouth, are usually
acceptance.
Usage
Name of Chemical Name and Use
Flavouringa Concentration
agents
1. Vanillin Vanillin is an organic compound
named (4-hydroxy-3-
methoxybenzaldehyde). As a
pharmaceutical excipient, vanillin is
used in tablets such as caffeine
tablets and polythiazide tablets,
solutions (0.01-0.02% w/v),
syrups, and powders
0.01% in oral syrups, It has a
2. Ethyl Vanillin
flavour and odour approximately
threetimes
as intense as vanillin.
Menthol (USP), Racementhol Menthol is broadly used in
3.
(BP) pharmaceutical preparations
especially for antacid tablets,
Suspension, and expectorant
tablets. It is capable to exert a
cooling or refreshing sensation and
used in topical preparations. 0.02-
0.05% for inhalation, 0.003% for
oral suspension, 0.005-0.015% for
oral syrup, 0.2-0.4% for Tablets
0.05-10.0% for Topical
formulations , 0.4% for Toothpaste
,0.1-2.0% for Mouthwash, 0.3%
forOral spray.
Manzanate (Ethyl 2-
4. Apple
methylpentanoate)
Banana lsoamyl Acetate also known as
5.
Isopentyl Acetate
. Coconut flavour y-Octalactone
7 Cinnamon Cinnamaldehyde
8. Grape Methyl Anthranilate
9 caraway Carvone &Limonene
|10. Pear Ethyl Decadienoate
11. Fruity Ethyl Propionate
12. Truffle 2,4-Dithiapentanee
13. Wintergreen Methyl Salicylate
14. Cherry Allyl Benzoate
15. Pineapple Allyl Hexanoate or Allyl Caproate
16. Anise Anethole, Anisaldehyde
17. |Lemon 3,7-Dimethyl-2,6-Octadienal
18. Orange d-Limonene, Ethyl Butyrate
 not less than
|19 Peppermint |In peppermint flavour,
Acetate and less
5% of menthyl
must
than 50% of total menthol
contain.
is a combination of the following
20. Mango |It
chemical flavour: 3-hydroxy-4,5-
dimethyl-2(5H)-furanone, ethy1-2
methybutanoate, (E, Z)-2,6-
nonadienal, 1-(E,Z)-undecatriene,

y-octalactone with Cultivar

modifiers
flavour
compounds as
butanoate for (fruity
such as ethyl
mango).
Ketone 1-Carvone, Limonene,
Spearmint or Mint to impart
21. Cineole are responsible
this flavour. And B-
d-Camphene
Gingerol,
2 2. Ginger Phellandrene_
3 , 5 - D i m e t h y l - 1 , 2 - C y c l o p e n t a d i o n e

23. Carame Linalyl Acetate

24. Lavender Eugenol
25. Clove Geraniol a n d I-Citronellol

or Gamma-
Rose Aldehyde C-14
Peach,
27. Peach Undecanolactone,
Raspbery Ketone (4-(4-
28. Raspberry Hydroxyphenyl) butan-2-one)
Ethyl Methylphenylglycidate
essence
29. StrawberrTy Cocoa, Cocoa liquor (the
Chocolate Flavour
30. of the cocoa bean)
Limonene, Cineol
Cardamon to
Prunasin is the main ingredient
31. Wild cherryy
32. impart wild cherry flavour.
For oral pharmaceutical
formulations as a flavouring agent.
Methionine
33.
odour and
It imparts caramel-like
34. Maltol taste but in dilute solution,
it
strawberry-like, or
imparts a sweet,

pineapple-like flavour and odour.

times
Its flavour and odour are 4-6
Ethyl Maltol maltol
35. as intense as maltol. Ethyl
0.004%
at concentrations of about
w/v is used in oral syrups. It
a caramel-like odour and
provides
taste but in a dilute solution, it
provides a sweet, fruitlike flavour
and odour.
36. Denatonium Benzoate It has been used as a favouring
in a
agent in placebo tablets,
in an ant-
topical formulation, and
nailbiting preparation.
In pharmaceutical preparations,
37. Ethyl Acetate used as a solvent
ethyl acetate is
It is also
and a ffavouring agent.
ence. t
used in artificial fruit
e s s

flavour-like
has Ether-like, sweet,
nail polish remover.
Sweet, ethereal, fruity,
38 Ethyl Lactate butterscotch buttery smell.

Acceptable daily intake for lactic

acid is 12.5 mg/kg body weight
Flavour enhancer and use for iron-
Monosodium Glutamate
39 containing liquids preparations
to
metallic taste. It has
reduce the
salty-smelling odours.
As a flavour enhancer for
its tart
40. Citric Acid Monohydrate
flavour and acidictaste.
flavour and
Dibutyl Sebacate Used as a synthetic
41. flavour adjuvant, up to 5 ppm
is
used in ice cream and non-

alcoholic beverages.
Also, known as hexane dioic acid
42. Adipic Acid
used to give tart flavour.
As a flavouring agent in
43. Capric acid
pharmaceutical preparations for
providing a citrus-likefiavour.
Malic Acid It imparts a slight apple flavour and
44. is used to mask bitter tastes and
provide tartness
Fumaric Acid Primarily used in a liquid
45.
pharmaceutical dosage form as an

acidulant and flavouring agent

Sodium Metabisulfite Above approximately 550 ppm at
46.
concentrations, it imparts a
noticeable flavour to preparations.
Thymol/Thyme oil Mainly used in cosmetics to impart
47.
a sharp, almost minty flavour.

20