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1. FORMULATIONS AND
BUILDING BLOCKS
Cosmetics and cosmeceuticals
Rajebhai Fayejabanu S.
M.Pharm Sem 2
APMC Pharmacy College
9/6/2021 1

2. CONTENTS
 SURFACTANTS
- Classification
- Application
 EMOLLIENTS
 Classification
 Application
 RHEOLOGICAL ADDITIVES
 ANTI-MICROBIAL as a preservatives
 BUILDING BLOCK FORMULATIONS
 Creams
 Shampoo
 Toothpaste
 Soaps
 syndetbars
9/6/2021 2

3.  PERFUMES
◦ Classification
◦ Ingredients listed asallergrns in EU regulation
 CONTROVESRSIAL INGREDIENTS:
◦ Parabens
◦ Formaldehyde liberators
◦ dioxane
9/6/2021 3

4. SURFACTANT
 Definition:
 A substance which tends to reduce the surface tension
of a liquid in which it is dissolved.
 Surfactant are ampiphilic in nature.
Ampi means “double”.
 Ampiphilic = having both hydrophilic & hydrophobic
parts.
 hydrophilic=lipophobe(polar ,high affinity)
 Hydrophobe=lipopphile(non polar , alkyl chain)
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5. 9/6/2021 5

6.  The primary performance function
surfactant is the lowering of interfacial
tension.
 ex. Cleansing, emulsion, dispersion
 Cleansing- lowering tension between
the oil / dirt, water and your skin or
hair
 Emulsion- lowering tension between
oil phase and water phase
 Dispersion- between particles and
water / oil 9/6/2021 6

7. Classification
1. Anionic surfactants:- Sulfate, sulfonate
2. Nonionic surfactants:- fatty acid ester,
ethoxylate
3. Cationic surfactants :-quaternary
ammoniums
4. Zwitterionic surfactants:- amino acid
derivatives
* A new class of surface active agents:
-Polymeric surfactants (polymer with surfactant
properties like poly acrylate ,
poly{ethyleneimine})
-Silicon surfactants
9/6/2021 7

8. 1. Anionic surfactants
 Anionic surfactants work best to remove dirt, clay, and
some oily stains.
 These surfactants works to follow ionization.
 When added to water, the anionic surfactants ionize
and have a negative charge.
 The negatively charged surfactants bind to positively
charged particles like clay.
 Anionic surfactants are effective in removing particulate
soils.
 Anionic surfactants play a major role in modern
cleaning products due to their superior detergency
performance.
 Example:
 Sulfonate , phosphate, sulfate and carboxylates. Alkyl
sulfates include ammonium lauryl sulfate, sodium
lauryl and the related alkyl-ether sulfates sodium laureth
sulfate, also known as sodium lauryl ether
sulfate (SLES), and sodium myreth sulfate.
9/6/2021 8

9. 2. Nonionic surfactants
 It Have no foaming capabilities so this group of
surfactants are rarely used.
 These surfactants do not have a charge in their water-
loving heads.
 Nonionic surfactants (like Polysorbate 20) perfect
solubilizers.
 Some common nonionic surfactants,
Polysorbates, Emulsifying Wax NF, E-wax, Glyceryl
Oleate, Glyceryl Stearate, ingredients with the prefix
PEG, Ceteareths, Oleths, Sorbitans, Lauryl Glucoside,
and Polyglycose.
9/6/2021 9

10. 3. Cationic Surfactants
 Cationic surfactants are the opposite of anionic
surfactants. They have a positively charged water-loving
head.
 It is because of this positive charge that cationic
surfactants can offer many skin loving, nourishing
benefits to the skin and body.
 Cationic surfactants alone do not allow for foaming
capabilities.
 Some common cationic surfactants,
Chlorides (Benzalkonium, Stearalkonium, and
Centrimonium), Trimethyl Ammoniums, and Methyl
Sulfates.
9/6/2021 10

11. 4.Zwitterionic (amphoteric) surfactant
s have both cationic and anionic centers attached to
the same molecule.
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12. 9/6/2021 12

13.  Some commonly added surfactants,
 Sodium lauryl sulfate
 It Produces High Foam; easy to thicken. Strong Anionic
Surfactant; can cause irritation.
 Disodium lauryl sulfosuccinate Foaming agent, Mild
Anionic Surfactant; gentle on the skin.
 Polysorbate 20 (vegetable derived)
polysorbate 80 (vegetable derived)
 Almond Glycerides
 Disodium lauryl sulfosuccinate
 Ammonium laureth sulfate
 Sodium Lauryl Sulphoacette
9/6/2021 13

14. 9/6/2021 14

15. EMOLLIENTS
 Meaning soother or softener, an emollient softens dry,
rough, flakey skin, making it look and feel better.
 Emollients are cosmetic preparations used for
protecting, moisturizing, and lubricating the skin.
 Emollients that contain a lot of oil are also occlusive
agents. This means they coat your skin with a thin oily
film that seals the water in your skin. Occlusive agents
keep your skin hydrated longer.
 The most common way to classify emollients is by how
oily or greasy they are.
 All emollients soften and smooth your skin, but the
amount of oil in them determines how strong of an
occlusive agent they are.
 The more oil an emollient contains, the better it is at
forming a protective layer on your skin to trap moisture.
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16. 9/6/2021 16

17. Types of emollients
 Emollients may be medicated or non-medicated.
 Non-medicated topical moisturizers contains occlusive
agents, emollients, and humectants.
 Occlusive agents coat the skin, forming a physical
barrier that prevents the loss of water.
 Emollients an occlusive barrier and they smooth flaky
skin cells, to make the skin look smoother. Some
spread more easily than others. Esters and oils can be
used.
 Humectants hey attract water from the atmosphere and
from the lower layers of skin to moisturize the surface of
the skin.
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18. USES
9/6/2021 18

19. RHEOLOGICAL
MODIFIERS
9/6/2021 19

20.  Rheology can be defined as “the science or study
of how things flow”
 Rheological modifiers are often referred to as
thickeners, and whilst increasing the apparent
viscosity will confer a feeling of “quality” to the
formulation, this is only one aspect of rheological
control.
 The product itself can be Newtonian or
pseudoplastic, thixotropic, be a ringing gel or a
stringy flowable liquid.
 Different types of rheology modifier are available to
the formulator .These include natural gums such as
guar and starch, modified naturals such as
cellulose derivatives, synthetics such as acrylic
polymers and inorganic such as clays.
9/6/2021 20

21. classifications.
 Polymeric Rheology Modifiers:
◦ These, usually acrylate based polymer
thickeners, are cost effective and efficient at low
use levels, can provide suspension of particles
but can be sensitive to salt content and tend to
short rheology.
 Mineral Colloidal Modifiers:
◦ Minerals (naturally sourced) such as Magnesium
Aluminum Silicate, Bentonite, and Hectorite can
be used to create colloidal systems which impart
viscosity in a non-Newtonian manner.
◦ Typically synergistic when used with gums
(xanthan). They also have a smooth, ‘dry’ feel.
◦ Hydrophobically modified minerals can also
provide rheology modification in non-aqueous
systems. 9/6/2021 21

22.  Associative Thickeners :
◦ These thickeners interact with surfactants in a
way that moderates flow and adds
viscosity. They can be sensitive to different
ingredients including sulfate free surfactants.
 Cellulosic Thickeners:
◦ Based on cellulose (wood pulp), these
synthetically modified polymers are similar to the
polymeric thickeners in that they can be highly
efficient. At higher use levels they can feel
slippery or stringy and do not provide suspending
properties. Hydrophobic modification can allow
for use in solvent systems
9/6/2021 22

23. 9/6/2021 23

24. ANTI-MICROBIALS
 DEFINITION:-
 Antimicrobial preservatives are substances added to
non-sterile dosage forms to protect them from
microbiological growth or from microorganisms that are
introduced inadvertently during or subsequent to the
manufacturing process.
 To prevent decomposition by microbial growth or by
undesirable chemical changes.
 Preservatives are substances that are commonly added
to various foods and pharmaceutical products in order
to prolong their shelf life.
 The addition of preservatives to such 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 molds that can cause disease.
9/6/2021 24

25.  Ideal Properties of Preservatives
1. It should not be irritant.
2. It should not be toxic.
3. It should be physically and chemically
stable.
4. Preservative 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.
9/6/2021 25

26. Classification preservatives
 A. CLASSIFICATION BASED ON MECHANISM OF
ACTION
 1. Antioxidants:
The agent which prevent oxidation of Active
pharmaceutical ingradient which otherwise undergo
degradation due to oxidation as they are sensitive to
oxygen.
Eg.Vitamin E
Vitamin C
Butylatedhydroxyanisole ( BHA).
Butylatedhydroxytoluene (BHT).
 2. Antimicrobial agents:
The agent which active against gram positive & gram
negative micro-organism which causes degradation of
pharmaceutical preparation. Which are active in small
inclusion level.
Eg. Benzoates
Sodium benzoate
Sorbates 9/6/2021 26

27.  3. Chelating agents:
The agents which form the complex with pharmaceutical
ingredient and prevent the degradation of pharmaceutical
formulation.
Eg. Disodium ethylenediaminetetraacetic acid (EDTA)
Polyphosphates
Citric acid
 B. CLASSIFICATION BASED ON SOURCE
 1. Natural Preservatives:-
These drugs are obtained by natural sources that is plant,
mineral sources, animal etc.
Eg. Neem Oil
Salt (sodium chloride)
Lemon
Honey
 2. Artificial Preservatives:
These preservative are man made by chemical synthesis
active against by various micro-organisms in small
concentration.
Eg. Benzoates
9/6/2021 27

28. List of preservatives
 Benzalkonium Chloride
 Benzoic Acid
 Cetrimonium Bromide
 Methylparaben
 Methylparaben Sodium
 Propylparaben
 Propylparaben Sodium
 Phenol
 Benzyl Alcohol
 Sodium Benzoate
 Benzethonium Chloride
9/6/2021 28

29. 9/6/2021 29

30. formulations
 Vanishing cream
 Moisturizing cream
 Cold cream
 Shampoo
 Toothpaste
 Soaps
 syndetbars
9/6/2021 30

31. 9/6/2021 31

32.  They are oil in water type of emulsion.
 When applied on the surface of skin, they spread as
thin oil less film which is not visible to the naked eye.
Hence, they are called as vanishing creams.
 They are used to hold powder on the skin as well as to
improve adhesion.
 Properties:
 · It should have high melting point.
 · It should be pure white in color.
 · It should possess very little odour.
 · It should have less number of iodine.
9/6/2021 32

33. Ingredients Uses
 1. Main ingredient
 Example: stearic acid
 USE: It governs the consistency of the cream and imparts pearlescent
property to the cream by forming crystals.
 2. Humectants
 Example : glycerin, sorbitol, Propylene glycol
 3. Alkalies
 Example : (a) Potassium hydroxide
 It imparts fine texture and consistency without providing harshness
 (b) Sodium hydroxide It is used in combination with potassium hydroxide
because it forms hard cream, when used alone.
 (c) Carbonates i.e., potassium and sodium carbonate
 They are widely used, because they liberate carbon dioxide due to this,
creams become spongy.
 (d) Ammonia.
9/6/2021 33

34.  (e) Borax
 It is effective, but difficult to handle because of odour and volatility. it is
also make cream yellow in color with age. It is used in combination with
potassium hydroxide to produce a white emulsion
 4. Emulsifying agent.
 Example : triethanolamine soap, Amino glycol soap or Glyceryl
monostearate
 5. Purified water (i.e., distilled and deionized)
 It provides stability to the cream. If hard water is used, it leads to the
formation of soaps of lime and magnesium, which causes inversion of
emulsion and hence stability is reduced.
 6. Preservatives
 Example : methyl paraben and propyl paraben
 They prevent deterioration cause by bacteria or fungi.
 7. Perfume i.e., perfume solvent or perfume is dissolved in alcohol.
 They should be added when the cream attains a temperature of about
40°c.
 Example: geranium, sandal wood, lavender oil, terpineol etc.
 It provides odour to the cream and also has aesthetic value.
9/6/2021 34

35. Formula Quantity for 100 g
Stearic acid (lubricant) 24 g
Potassium hydroxide (softening agent) 1 g
Water (vehicle) 64 g
Glycerin (humectants 10.5 g
Perfume (odour) 0.5 g
Method:
•Stearic acid is melted in a container by using water
bath. Potassium hydroxide is dissolved in water and
then glycerin is added.
•This mixture is heated to a temperature of about 75'
C. This is aqueous phase.
•Slowly aqueous phase is added to melted stearic
acid along with continuous stirring.
•Perfume is added to the preparation when it attains a
temperature of 40° C 9/6/2021 35

36. 9/6/2021 36

37.  Cold Creams:
 Creams are water-in-oil type of emulsion.
 They produce cooling sensation by the evaporation of
water, after application of cream to the skin. Hence,
they are known as cream.
 They should possess emollient action and the layer left
on the skin after application should be non-occlusive.
formula quantity for 100 g
White beeswax (emollient) 20 g
Mineral oil (lubricant) 50 g
Distilled water (vehicle) 28.8 g
Borax (buffer) 0.7 g
Perfume (odour) 0.5 g
9/6/2021 37

38.  Method:
 Beeswax is melted in a container by using water bath to
a temperature of about 70° C.
 Then mineral oil is added to the melted beeswax. This
is mixture A.
 In another container, water is heated to a temperature
of about 70° C and borax is dissolved in it. This is
mixture B.
 Mixture B (aqueous phase) is added slowly to mixture A
(oily phase) along with stirring.
 Stirring is carried out until a creamy emulsion is formed.
 Finally, perfume is added to the preparation when it
attains a temperature of about 40°C.
9/6/2021 38

39. Evaluation of Creams
 1. In-vitro methods
 (a) Tensile strength tester
 (b) Hargen's Gas Bearing Electro dynamometer (GBE)
 (c) Occlusive potential of ingredients.
 (d) Gravimetric analytical method.
 (e) Thermal analytical methods.
 (f) Electrical methods.
 2. In-vivo methods.
 (a) Transpirometry
 (b) Scanning electron microscopy (SEM)
 (c) Optical microscopy and macro photography.
 (d) Skit friction
 (e) Sensitivity tests.
◦ (i) 21 Day (or 3 Weeks) Cumulative Irritancy Patch test
◦ (ii) Draize-shelanski repeat-insult Patch Test
◦ (iii) Kligman “Maximization" Test
9/6/2021 39

40. In-vitro methods
 Tensile Strength Tester:
 This method is useful for determining the tensile
property of the excised stratum corneum of the skin. It
provides information on the water content present in
stratum corneum and also acts as a screening device
for moisturizing ingredients.
 (b) Hargen's Gas Bearing Electro Dynamometer
(CBE):
 This instrument is helpful in determining and monitoring
the viscoelastic behavior of the skin.
 It also helps in determining the effects on the skin by
passing it through various treatments.
 It is used both as in-vitro and in-vivo test.
9/6/2021 40

41.  (c) Occlusive Potential of Ingredients:
 The occlusive potential of raw materials or ingredients
used in the formulation of skin cream, are determined
by knowing the water diffusion rate.
 Membranes used in this method can be stratum
corneum of neonatal rat or artificial membrane.
 2. In vivo Methods:
I. Transpirometry:
 This method helps in measuring Trans Epidermal Water
Loss (TEWL) of the skin which helps in providing
information on moisturizing potential.
 Scanning Electron Microscopy (SEM): Skin replicas are
used in this method to know the effects of topical
preparations on the skin conditions i.e., dry and rough
skin (good substrate).
9/6/2021 41

42.  (c) Optical Microscopy and Macro photography:
 With the help of low magnification photography,
stereomicroscopic tests, biopsies of skin surfaces and
microphotographs, the changes in the dry rough skin
are observed before and after application of
moisturizers.
 They also provide information on moisturizing potential
preparations.
 (d) Skin Friction:
 Damp (slightly wet) skin has high friction surface
compared to wet and dry skin.
 Investigation of friction surface shows the relation
between the effect of hydration on stratum corneum and
process of moisturization.
 Frictional properties are also related to elastic nature of
skin and helps in evaluating the performance of the
product.
9/6/2021 42

43.  (e) Sensitivity tests:
 These tests are performed in order to measure
the irritancy, sensitization potential and
phototoxicity of the skin.
◦ (i) 21 Day (or 3 Weeks) Cumulative Irritancy
Patch test
◦ (ii) Draize-shelanski repeat-insult Patch Test
◦ (iii) Kligman “Maximization" Test
9/6/2021 43

44. 9/6/2021 44

45.  Definition:
 A viscous cosmetic preparation with synthetic detergent used for
washing hair is called shampoo.
 Its principle function is to clean the scalp such that it should become
free from sebum and foreign substances.
 Properties:
 It should have good spreading properties.
 It should produce sufficient lather after application.
 It should be able to remove waste material such as debris, soil,
sebum, dead cells, salts (due to sweat) etc., from the scalp.
 It should not form any kind of film on scalp.
 It should rinse out completely after washing.
 It should produce lather with both hot and cold water.
 It should provide lustre to the hair.
 It should produce good odour both before and after shampooing.
 It should not produce any kind of irritation or itching to the scalp.
 It should not support any microbial growth.
 It should be stable and have a half life of about 2 to 3 years.
 it should be economical.
9/6/2021 45

46. Types of shampoo
 1. Clear liquid shampoos
 2. Liquid cream shampoos
 3. Cream shampoos
 4. Gel shampoos
 5. Powder shampoos
 6. Aerosol shampoos (Foam type)
 7. Special shampoos
◦ (a) Medicated Shampoo
◦ (b) Conditioner Shampoos
 1. Clear Liquid shampoo:
 These are clear liquid preparations that are most widely used.
 They are usually made by using detergent of low cloud point.
Alkanolamides can also be used in these preparations. Some
of these shampoos may be transparent
9/6/2021 46

47.  2. Liquid Cream Shampoos:
 These are called as lotion shampoos which are modification of clear
liquid shampoos. Addition of opacifier such as glycerylmonostearate,
glycol stearate etc., to the clear liquid shampoo yields liquid cream
shampoo.
 Solubilising agents such as magnesium stearate is also used to
dissolve the added opacifier.
 3. Cream Shampoos:
 These shampoos have a paste like consistency and are packed in a
collapsible tube.
 They find great use in hair salons. They are also available in jars
with wide mouth.
 The paste consistency is developed by addition of alkyl sulphates,
also Cetyl alcohol is added, which serves as a builder.
 4. Gel Shampoo:
 These are transparent and thick usually made by incorporating a
gelling agent, (e.g., cellulose).There is great use in hair salons and
beauty parlors.
 The principle ingredient is detergent which can be used either alone
or in combination with soap.
 By altering the proportion of detergent, gel of required consistency
can be obtained.
9/6/2021 47

48.  Addition of methyl cellulose to clear liquid shampoo and its
subsequent thickening also gives rise to gel shampoo.
 5. Powder Shampoos:
 As name suggests, it is available in the form of dry powder, initially it
was prepared from dry soaps, but nowadays dry synthetic
detergents are used for their preparation.
 Powder shampoo is prepared where addition of water or other
solvent reduces the activity of the components, especially in case of
medicated shampoo.
 Nowadays, these shampoos are not used due to the difficulty
experienced in their application.
 Another formulation called dry shampoo is also a type of powder
shampoo. Initially they are applied on to the head and then removed
by the brush. it doesn't involve the use of water.
 They are usually preferred, when the hair are greasy. This
formulation usually includes adsorbents
9/6/2021 48

49.  6. Aerosol Shampoos (Foam Type):
 They are called aerosol shampoos because they are
 packed in aerosol containers .
 Their formulation, preparation and packing is complicated as
an additional propellant is included.
 The propellant added must be compatible and should not
reduce the activity of shampooing ingredients. The container
opening is provided with a valve.
 Shampoo comes out as foam when the valve is pressed
.Hence also called as foam type shampoo.
 7. Special Shampoos
 (a) Medicated Shampoo:
 These shampoos contain medicinal agents. These agents
treat the disorders of the scalp or hair.
 Examples of medicated shampoos are: Anti-lice shampoo,
Antidandruff shampoo, Anti-baldness shampoo etc,.
9/6/2021 49

50.  (b) Conditioner Shampoos:
 These shampoos serve for hair conditioning. Initially
they clean the hair (and scalp) and keep them in
smooth and lustrous condition.
 They also prevent sticking of hairs.
 Conditioner shampoo nowadays is widely used by both
men and women.
 Most of the conditioners are made from Quaternary
ammonium compounds.
 These compounds have the property of reducing
electric charges between the hair, as a result hair
become lustrous easily manageable.
 These compounds can also exhibit a bactericidal effect.
9/6/2021 50

51. Formulation contains of
shampoo
Ingredients Examples
1. Surfactants
(a) Anionic Surfactants Alkyl sulphates, alkyl ether sulphate
(b) Non- ionic Surfactants Alkanolamides
(c) Cationic Surfactants Alkyl amines, alkyl imidazolines
(d) Amphoteric surfactant Acyl amino acids
2. Foam booster Monoethanolamides, lauramides DEA, cocamide
DEA
3. Germicide and anti-dandruff Banzalkoniumchloride, cetrimide, selenium
agent sulphide, cadmium sulphide
4. Conditioning agent Lanolin, egg, amino acids
5. Pearlescent agent 4-methyl-7-diethylamino coumarin, 4-methyl-5,7-
dihydrocoumarin
6. Sequestrants EDTA, citric acid, tripohyphosphate
7. Thickeners Alginates, polyvinyl alcohol, methyl cellulose
8. Perfuming agent Herbal fruits or floral fragrance
9. Preservatives p-hydroxyl benzoic acid phenyl mercuric nitrate
10. Colour FD and C dye
9/6/2021 51

52. Preparation of shampoo
 (a) Preparation of Cream Shampoo:
 Initially, a solution of detergent and water are
heated to about 80°C.
 The wax is heated separately in a container at
80°C which facilitates the melting of wax.
 Both the solutions are kept at 80°C and mixed
uniform mixing by constant and gentle stirring.
 The solution is allowed to cool to about 40- 45°C.
After which the remaining ingredients, such as
additives, colours, perfume and preservatives are
added.
 The stirring is continued Finally, under warm
conditions, the mixture is transferred into a suitable
container and packed
9/6/2021 52

53.  (b) Preparation of Gel Shampoo:
 The method involved in the preparation of gel shampoo is similar
to that of clear liquid shampoo.
 After preparation, the liquid shampoo is usually treated with a
suitable thickening or gelling agent such as hydroxy propyl
methyl cellulose,
 this gives a gel like consistency. Addition of appropriate amount
of anionic and amphoteric surfactants also leads to the formation
of gels
 (c) Preparation of Aerosol Shampoo:
 This type of shampoo is initially prepared by using (earlier
discussed) general method. The prepared shampoo is then
incorporated with a suitable propellant.
 The whole mixture is packed in an aerosol container.
 The propellant creates a pressure within the container due to
which spraying action is achieved and the product (shampoo) is
sprayed in the form of foam.
 Here packing plays an important role and the propellant used
should not react with the shampoo.
9/6/2021 53

54. (d) Preparation of Powder Shampoo:
 Powder shampoo is prepared by simple blending.
 Here, all the ingredients are taken in a state. They
are powdered to suitable degree of fineness.
 The powdered ingredients are blended by using a
suitable blender. Two separate solutions of
perfume and colour are prepared by using alcohol
or water as solvents.
 The prepared solutions are then sprayed onto the
blended mixture. The wet mixture is dried and
packed. Otherwise, the ingredients are internally
soaked into the solutions of colour and perfume.
 Wet mass is dried and then subjected to blending
9/6/2021 54

55. Evaluation of shampoo
 (I) Evaluation of Safety
◦ (a) Skin Toxicity Test
◦ (b) Eye Toxicity Test
 (II) Evaluation of Antimicrobial Property.
 Evaluation of Safety:
 shampoos are made from synthetic detergents, which are
liable to irritate skin, scalp and eye.
 the shampoo must be non-toxic and non-irritative. The safety
is usually evaluated it, terms of toxicity i.e., if the preparation
is found to be non toxic then it is regarded as safe and vice-
versa.
 However, the toxicity is determined by using “Draize test”
which suggests two separate methods for testing skin and
eye toxicity respectively.
 The methods are as follows:
9/6/2021 55

56.  (a) Skin Toxicity Test:
 On the skin of each rabbit, a round patch is made by removing hair.
 Dilute preparation (8-10%) of shampoo is usually applied onto the
patches of a rabbits.
 The shampoo is allowed to react for a period of 3-4 hours. After that
it is removed completely from the skin.
 After efficient washing, the skin is examined for any adverse
reactions such as erythema, edema etc.
 Based on the results obtained the shampoo is considered as either
safe or toxic.
 Usually, there might be chances of adverse reactions because the
shampoo was kept in contact for 4 hours. But usual practice of
shampooing in human being is for 10-15 minutes.
 Alternatively, the skin test is also performed on human being.
9/6/2021 56

57.  (b) Eye Toxicity Test:
 One eye of each rabbit is considered as test eye and
another as control eye.
 To each of the six test eyes of six rabbits, the product
(shampoo) is applied.
 Washing is done after 20 seconds pith 200 ml of tap
water.
 The eyes are rewashed after 5 minutes and then after
24 hours.
 The control eye are also washed on first day and then
after 24 hours.
 The test eyes are observed at 1, 24, 48 and 72 hours
respectively.
 They are also examined on 7th and 14th day.
 The product is said to be toxic, if there is a development
of iris and corneal lesions which remains for more than
7 days. 9/6/2021 57

58.  Evaluation of Antimicrobial
 Shampoos are liquid or viscous preparations,they are
liable to microbial growth.
 preservative is usually added to prevent microbial
growth .
 Preservative properties.
 -It should be non toxic.
 · It should be compatible with other ingredients.
 · It should be effective at low concentration,
 · It should be effective against wide variety of
microorganism.
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59. 9/6/2021 59

60.  Dentifrices such as toothpastes, tooth powders and
tooth gels are meant for the cleaning the surface of the
teeth by removing the food debris and plaque adhered
to surface of the teeth which is the main cause for tooth
problems.
 General requirements for a dentifrice:
 It should leave a pleasant, cool and refreshing
sensation in the mouth.
 It should be harmless, non-toxic and should not cause
irritation in the mouth or any ulcers in the buccal cavity
 It should be easy to pack and easy to use.
 It should be capable of cleaning the teeth adequately by
removing food debris, plaque and stains efficiently.
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61. Formulation:
 Characteristics:
 (a) They should not produce any gritty
sensation in the mouth.
 (b) They should possess good abrasive
properties.
 (c) They should not lead to any
incompatibilities and should be compatible
with the other ingredients.
 (d) They should be harmless to the enamel
and the abrasive property should be under
limits.
 (e) They should provide a good shine to the
enamel. 9/6/2021 61

62. Ingredients Examples
Agents responsible for cleansing
Action
· Polishing agents/abrasive
agents
· Foaming agents/surfactants
Agents responsible for cleansing
Action
· Polishing agents/abrasive
agents
· Foaming agents/surfactants
Agents responsible for the
formation Of toothpastes
· Humectants
· Gelling agents/binding agents
(a) Sorbitol 70
(b) Glycerin
(c) Propylene glycol
(a) Sodium carboxy methyl cellulose (SCMC)
(b) Cellulose ethers
Agents responsible for improving
Palatability
· Sweetening agents
· Flavouring agents
(a) Sodium saccharin
(b) Chloroform
(c) Cinnamon bark
(d) Spearmint oil etc.
Miscellaneous agents
· Coloring agents
· Whitening agents
· Preservatives
· Therapeutic agents
9/6/2021 62

63. Preparation of toothpaste
 Two methods
 ·Dry gum method.
 Wet gum method
 1. Dry Gum Method:
 In this method, all the solid components of the formulation like
abrasive agent, binding agent etc., except the surfactants are
mixed together in a dry mixer.
 The mixer may be an agitation mixer which consists of slow
rotating blades.
 The liquid components such as the humectants and water are
gradually added to the dry mix.
 The mixing process is carried out till a smooth paste is
formed.
 The remaining ingredients like the surfactants and the
flavouring agents are added to the homogenous paste under
vacuum.
9/6/2021 63

64.  2. Wet Gum Method:
 In this method, all the liquid components are mixed
together to form a liquid phase.
 The binding agent is then mixed with the liquid phase
with uniform stirring in order form mucilage.
 The solid ingredients excluding the surfactants are then
gradually added to the mucilage with uniform mixing in
an agitation mixer, in order to form a homogenous
paste.
 The remaining ingredients i.e., the surfactants, the
flavoring agents, coloring agents are added under
vacuum t the homogenous paste.
9/6/2021 64

65. Evaluation of toothpaste
 1. Tests for Abrasive Character
 2. Determination of Particle Size
 3. Test for Cleansing Property
 4. Determination of Consistency of the Product
 5. Determination of pH of the Product
 6. Determination of Foaming Character
 7. Determination of the Volatile Matter and the
Moisture Content
 8. Determination of the Test for the Special
ingredient
 9. Limit Test for Heavy Metals
9/6/2021 65

66.  Determination of pH of the Product: A
 10% solution of the paste in water is made and the pH of the
dispersion is measured using a pH meter. The pH should be in
the range of 6.8 to 7.4 in order to maintain the consistency of the
product.
 Determination of Foaming Character:
 This test for the foaming character is applicable only to foaming
tooth powders and pastes. In this test, specific amount of the
product is mixed with a known amount of water.
 The solution is then shaken sometimes in order to produce
foam. The foam produced is then collected and studies on its
nature, washability and stability are carried out.
 Determination of Particle Size:
 Particle size determination is important as the cleansing nature
and abrasive property of the dentifrice mainly depends on the
particle size.
 The particle size can be determined by using microscopical
techniques or by involving the method of sieving.
9/6/2021 66

67.  Determination of Grittiness:
 The presence of hard, sharp-edged abrasive particles were
evaluated by extruding near about 15 to 20 mm length paste
from a collapsible tube of each sample on butter paper then
pressed it along its entire length by finger.
 Determination of the Test for the Special ingredient:
 The use of therapeutic ingredients may lead to certain
incompatibilities and hence specific tests are done in order to
determine the effect of the specific ingredients such as
antiseptics, enzymes etc.
9/6/2021 67

68. 9/6/2021 68

69.  Soaps are sodium or potassium salts of long chain fatty
acids.
 When triglyceride in fats/oil react with aqueous NAOH /
KOH , they convert into soap & glycerol .
 This is called alkaline hydrolysis of esters.
 Since this reaction leads to the formation of soap, it is
called saponification process.
 The word ‘’syndet” is derives from ‘synthetic’ combined
with ‘detergent’.
 Technically it refers to the binding that occurs between
detergents, also called as surfactants.
 Syndet soap surfactants are derived from oils, fats /
petroleum products that are processed from a wide
range o chemical processes other than traditional
saponification.
9/6/2021 69

70. Ingredient for making soap:
 1) fats & oils:
 A fat mixture containing saturated & unsaturated
, long & short chain fatty acids in proportion are
used in manufacture of soap.
 Eg:
◦ A very common mix. For manufature of soap is 75%
tallow & 25% coconut oil.
◦ Saturated fatty acids with 12-18 carbon atoms include
lauric , myristic , palmitic , stearic & oleic acids are
used.
 2) alkali:
 An important raw material in soap making is
caustic soda(NaOH).
 Caustic potah (KOH) is used for making soaps.
9/6/2021 70

71. Other additives:
 1) anti-oxidants
◦ Used to stabilize the soap against rancidity.
◦ Eg. Sodium silicate, sodium hyposulphite,
sodium thiosulphate.
 2) whiteners
◦ Titanium dioxide and zinc oxide are used to
improve whiteness.
 3) perfumes
◦ The pH pf the soap is around 10.0 the
selected perfume should be stable in ths pH
range.
9/6/2021 71

72. SAPONIFICATION method
 COLD & SEMI-BOILED PROCESS
 FULL BOILED PROCESS
 CONTINUOUS PROCESS
 1) COLD & SEMI-BOILED PROCESS
 In this process are the simplest process of soap making
 These processe, fat is reacted with strong alkali and
strong alkali is nearly equal to that just required for
saponification.
 semi Process is differ from cold process in the fact that
the saponification.
 Mixture is heated to 70-90 c . Using a steam heated coil
to accelerate and complete the saponification reaction
after the saponification is complete other ingredients
added.
9/6/2021 72

73.  Cold process, mixing of fat and strong
alkal is carried out substantially at
room temp so that more than
emulsification take place.
 Saponification is completed after this
mix is run into frames in several days
at warm temp then additional of other
ingredients.
9/6/2021 73

74. 9/6/2021 74

75.  FULL BOILED PROCESS
 in this process, large cylindrical kettles with cone
bottoms equipped with open and sometimes with
closed coils for steam are used.
 full boiled process includes saponification
reaction graining out and washing strong charge
finishing operation.
 CONTINUOUS PROCESS
 This process are used for very large scale
production .
9/6/2021 75

76. Types of Soaps (Different
Making Process & Different
Usage)
 Glycerin Soap
 Transparent Soap
 Liquid Soap
 Medicated Soap
 Beauty Soap
 Guest Soap
 Novelty Soap
 Laundry Soap
 Kitchen Soap
9/6/2021 76

77.  Medicated Soap
 Medicated soap is soap with added antiseptics and
disinfectants to kill bacteria.
 Beauty Soap
 Beauty Soap features fragrance and ingredients for
different skin types. They can feature special oil blend
or glycerin.
 Novelty Soap
 Soap that comes in various shapes colors such as fish,
cake, and mustache. Novelty soap serves more than a
cleaning soap. It provides enjoyment and amusement to
the children who use them.
 Guest Soap
 Mini soap, generally smaller than the usual soap bar
and comes with various attractive shapes. Designed for
guests usage.
9/6/2021 77

78.  Transparent Soap
 Made by hot process method. Usually added some form
of alcohol to make it transparent.
 Sugar syrup (sugar in distilled water) is an alternative
ingredient to replace alcohol but not as effective as
alcohol. Some of the manufacturers in the market use a
ready-made soap base to make their transparent
soaps.
 Liquid Soap
 Making process is more complicated than soap bar.
Usually made with the hot process method. It becomes
liquid form due to a different type of lye (potassium
hydroxide instead of sodium hydroxide) is use in the
making process and also due to more water is added.
9/6/2021 78

79.  Kitchen Soap
 Kitchen soap is a soap intended for use in the
kitchen mainly to serve the purpose of dish-washing.
 Laundry Soap
 Effective in cleaning solid particles, grease and organic
compound in clothes. Can be quite convenient to wash
clothes during travels because it is easy to carry.
 Glycerin Soap
 Glycerin is a component of oil or fat. Any handmade
soap contains glycerin, a byproduct of the chemical
reaction of the soap-making process.
 Unlike most commercial soaps, glycerin is being
purposely removed by the manufacturer to sold for
other product making usage like cosmetic or
moisturizer.
9/6/2021 79

80. EVALUATION
 Determination of clearity, colour & odour
 Determination of pH
◦ Dissolved in 100 ml water & store 24 hr.
◦ & check previously calibrated pH meter.
 Determination of foam test
◦ Take 0.5g soap, dispersed in 25 ml water.
◦ Transfer to 100 ml measuring sylinder , & vol adjust
50 ml.
◦ Shake the sample solution 25 times & measure foam
hight.
 Determination of % alkali
◦ Take 5g sample in conical flask-- add into 50ml
neutralized alcohol
◦ Boilled under reflux condition for 30 min , cooled &
add 1 ml phenolphthalein. ---- and titrate
immediately 0.1 N Hcl. 9/6/2021 80

81.  Determination of alcohol insoluble matter
◦ 5g sample take n flask, 50ml warm ethanol add
& shake vigorously to dissolved
◦ Filer solution with 20 ml ethanol & dried it at
105 c for 1 hr.
◦ % alcohol insoluble
matter = wt of residue
wt of sample * 100
9/6/2021 81

82. Perfume
 Perfume (Fragrance) is a mixture of essential oils or
aroma compounds, used to give the human body "a
pleasant scent".
 Fragrances are used in a wide variety of products to
impart a pleasant odour, mask the inherent smell of
some ingredients, and enhance the experience of
using the product.
 Fragrances can communicate complex ideas – creating
mood, signalling cleanliness, freshness, or softness,
alleviating stress, creating well-being, and triggering
allure and attraction.
 The word perfume derives from the Latin perfumare,
meaning "to smoke through".
 The most practical way to start describing a perfume is
according to the elements of the fragrance notes of the
scent or the "family" it belongs to, all of which affect the
overall impression of a perfume from first application to
the last lingering hint of scent.
9/6/2021 82

83.  Perfume is described in a musical metaphor as having
three sets of notes, making the harmonious scent accord.
 The notes unfold over time, with the immediate impression
of the top note leading to the deeper middle notes, and the
base notes gradually appearing as the final stage.
 These notes are created carefully with knowledge of the
evaporation process of the perfume.
◦ Top notes
◦ Middle notes
◦ Base notes
 Top notes: The scents that are perceived immediately on
application of a perfume. Top notes consist of small, light
molecules that evaporate quickly.
 They form a person's initial impression of a perfume and
thus are very important in the selling of a perfume. Also
called the head notes.
9/6/2021 83

84.  Middle notes: The scent of a perfume that emerges
just prior to the dissipation of the top note.
 The middle note compounds form the "heart" or main
body of a perfume and act to mask the often unpleasant
initial impression of base notes, which become more
pleasant with time. They are also called the heart
notes.
 Base notes: The scent of a perfume that appears close
to the departure of the middle notes. The base and
middle notes together are the main theme of a perfume.
 Base notes bring depth and solidity to a perfume.
Compounds of this class of scents are typically rich and
"deep" and are usually not perceived until 30 minutes
after application.
9/6/2021 84

85.  The traditional classification which comprised the following
categories:
◦ Single Floral, Floral Bouquet, Amber or "Oriental", Woody
,Leather, Chypre, Fougère.
 New categories have emerged to describe modern scents:
◦ Bright Floral, Green, Aquatic, Oceanic, or Ozonic, Citrus ,Fruity,
Gourmand, Aromatics
 Perfume could be derived from following various sources.
 Plant sources: Bark, Flowers and blossoms, Fruits, Leaves
and twigs, Roots, rhizomes and bulbs, Seeds, Woods
 Animal sources: Musk, Ambergris, Castoreum, Civet,
Hyraceum, Honeycomb
 Other natural sources: Lichens, Seaweed
 Synthetic sources: Many modern perfumes contain
synthesized odorants. Synthetics can provide fragrances
which are not found in nature.
9/6/2021 85

86. 9/6/2021 86

87. Controversial ingredients
 Parabens
 Parabens are widely used as preservatives in
personal care products, but are also
controversial.
 Parabens are one of the most common
preservatives used in cosmetic products.
 They are used in a wide variety of products
including shampoos, lotions, deodorants, scrubs
and eye makeup.
◦ Ex.
 Methylparaben
 Methyl phydroxybenzoate
 Ethylparaben
 Ethyl phydroxybenzoate
 Propylparaben
 Propyl phydroxybenzoate
9/6/2021 87

88.  Parabens are white, odourless, fine crystalline
substances. A strong taste occurs at concentrations
above 0.08%.
 This taste is often described as metallic.
 Use in food in higher concentrations is therefore limited.
However, parabens are odourless, do not discolour
cosmetic products and are inexpensive to manufacture.
 Parabens are effective preservatives that work well in a
wide pH-range from 4.5 - 7.5.
 Parabens are quite resistant against hydrolysis and are
stable in the temperature ranges required for the
production of cosmetics.
 The good stability against external conditions,
combined with quite low costs of production, explains
why parabens are so commonly used.
9/6/2021 88

89.  FORMALDEHYDE AND FORMALDEHYDE-
RELEASING PRESERVATIVES
 Formaldehyde and formaldehyde-releasing
preservatives (FRPs) are used in many personal
care products,particularly in shampoos and liquid
baby soaps.
 These chemicals, which help prevent microbes
from growing in water-based products, can be
absorbed through the skin and have been linked
to cancer and allergic skin reactions.
 FOUND IN: Nail polish, nail glue, eyelash glue,
hair gel, hair-smoothing products, baby
shampoo, body soap, body wash, color
cosmetics.
9/6/2021 89

90.  These preservatives release small amounts
of formaldehyde over time.
 Since low levels of formaldehyde can cause
health concerns at levels as low as 250 parts
per million and even lower levels in sensitized
individuals the slow release of small amounts
of formaldehyde are cause for concern.
 preservatives[3] [4] such as quaternium-15,
DMDM hydantoin, imidazolidinyl urea,
diazolidinyl urea, polyoxymethylene urea,
sodium hydroxymethylglycinate, bromopol
and glyoxal.
9/6/2021 90

91.  Quaternium-15 is the most sensitizing of these FRPs
and is found in blush, mascara, lotion and shampoo.
 DMDM Hydantoin is found in lotion, sunscreen and
make-up remover and is one of the least sensitizing of
the FRPs.
 Imidazolidinyl urea, diazolidinyl urea, and
polyoxymethylene urea, are found in shampoo,
conditioner, blush, eye shadow, and lotion and are all
known human allergens.
 Imidazolidinyl urea is one of the most common
antimicrobial agents used in personal care products and
is often combined with parabens to provide a broad
spectrum preservative system.
 Diazolidinyl urea releases the most formaldehyde of
any FRP.
9/6/2021 91

92.  Sodium hydroxymethylglycinate is found in
shampoo, moisturizer, conditioner, and lotion. Animal
studies have shown that sodium
hydroxymethylglycinate has the potential for
sensitization and dermatitis.
 Bromopol is found in nail polish, makeup remover,
moisturizer and body wash. Bromopol is considered
safe in concentrations less than 0.1%, but cannot be
found in formulations with the FRP amine.
 Mixing bromopol and amines produce nitrosamines
(Link to same chemical in nitrosamines) which have
been found to penetrate the skin and cause cancer.
 Glyoxal is found in conditioner, lotion, nail polish and
nail treatment. CIR Expert Panel has declared that
glyoxal is a skin allergen.
9/6/2021 92

93.  REGULATIONS: Banned from use in cosmetics and toiletries
in Japan and Sweden; in the EU, restricted in personal care
products, and labeling is required in products that do contain
these chemicals; concentration restrictions in Canada.
 The EU allows the use of Quaternium-15 up to 0.2% as a
preservative in cosmetic products.
 1,4-dioxane
 1,4-dioxane, a carcinogen linked to organ toxicity.
 FOUND IN: Products that create suds (such as shampoo,
liquid soap, bubble bath), hair relaxers, others.
 WHAT IS 1,4 DIOXANE?
1,4-dioxane is generated through a process called
ethoxylation, in which ethylene oxide, a known breast
carcinogen, is added to other chemicals to make them less
harsh.
 REGULATIONS: Banned/found unsafe for use in cosmetics
in Canada
9/6/2021 93

94. Reference:
 Gaurav K Sharma, Jayesh Gadiya,
Formulations, toothpaste, creams, shampoo: A
Textbook of Cosmetic Formulations May 2018,
51-67, 16-28.
 https://www.researchgate.net/publication/325023
106
 www.slideshare.net, surfactant page no. 1-5.
 https://en.m.wikipedia.org/moisturizer
 https://slideplayer.com/humectant,surfactant
 Cosmetics-formulation, manufacturing and
quality control by P.P.sharma 4th edition ,
vandana publications page no.539-554,615-633.
 Melgardt De Villiers, PhD, Antimicrobial
Preservatives , page no: 203-204,213.
9/6/2021 94

95.  http://www.cdc.gov/nceh/drywall/docs/whaty
oushouldknowaboutformaldehyde.pdf
 Environmental Protection Agency (2003). 1,4
Dioxane (CASRN 123-91-1). Integrated Risk
Information System. Available at
http://www.epa.gov/NCEA/iris/subst/0326.htm.
9/6/2021 95

96. Questions
1. Write a note on building block
formulations of vanishing cream and
moisturizing cream.
2. Antimicrobial are used as a
preservatives: explain along with
factors affecting efficacy of microbial
preservatives.
3. Give a brief note on perfumes used in
cosmetics.
4. Explain surfactant with its classification
and application.
5. Note on Antimicrobial agent as
preservatives with its merits and
demerits. 9/6/2021 96

97. 9/6/2021 97