2. 1. Definition of cosmetics.
2. Classification.
3. Raw materials including Water, Oils, Fats,
Waxes, Emulsifiers, Thickeners And Gums,
Colours, Antioxidants, Preservatives,
Perfumes, Fragrance Selection, Stability and
Testing.
4. Microbiological aspects of cosmetics.
5. Safety testing and toxicology, Efficacy Testing
6. Instrumental and Sensorial Evaluation of
cosmetics
7. Labelling, Legislation and regulations for
cosmetics (Drug and Cosmetics Act, 1940 &
Rules 1945),
8. BIS specifications
Mrs. Nisha Marcel
Pharmaceutics II CBCS 2
3. Mrs. Nisha Marcel
Pharmaceutics II CBCS 3
“Cosmetics are substances or products used to enhance or alter the appearance of the face
or fragrance and texture of the body.”
“Intended to be applied to the human body for cleansing, beautifying, promoting
attractiveness, or altering the appearance without affecting the body's structure or
functions.”
*Excludes pure soap from this category
4. Mrs. Nisha Marcel
Pharmaceutics II CBCS 4
Pale-
faced Elizabeth I
of England has
been thought to
wear Venetian
Ceruse
Iridescence
in soap bubbles.
Lipsticks with
shimmering
effects were
initially made
using a
pearlescent
substance found
in fish scales
Cosmetics are
mentioned in the
Old Testament,
such as in 2 Kings
9:30, where
Jezebel painted
her eyelids
approximately 840
BC
Traditional
Chinese
medicines is the
fungus Tremella
fuciformis, used
as a beauty
product by women
in China and
Japan.
19th century,
Queen Victoria
publicly declared
make-up
improper, vulgar,
and acceptable
only for use by
actors.
1968 the feminist
Miss America
protest
The world's
largest cosmetics
company is
L'Oréal
Source: Wikipedia
6. 4. COSMETICS FOR THE NAILS
• Cuticle Creams
• Oils & Removers
• Nail Bleaches & Stain Removals
• Nail Laquers & Removals
• Fingernail Elongators
6. COSMETICS FOR VUNERABLES
• Cosmetics For Babies
• Cosmetics For Elderly
• Hypo-allergenic Cosmetics
Mrs. Nisha Marcel
Pharmaceutics II CBCS 6
9. MISCELLANEOUS COSMETICS
• Aerosol Cosmetics
• Cosmetic Patches
• Herbal Cosmetics
5. COSMETICS FOR THE TEETH
• Toothpastes
• Tooth Powders
• Mouth Washes
7. ESSENCE, PERFUMES & FRAGRANCES
8. TOILET SOAPS
7. Mrs. Nisha Marcel
Pharmaceutics II CBCS 7
TYPES
Lipsticks,
Plummer, primer,
balm, gloss, liner,
stain, conditioner,
butter, booster
Foundation is used
to smooth out the
face by covering
spots, acne,
blemishes, or
uneven skin tone
Face powder sets
the foundation and
under eye
concealer
Covers
imperfection of
skin
8. Mrs. Nisha Marcel
Pharmaceutics II CBCS 8
TYPES
Rouge, blush, or
blusher is cheek
coloring to bring
out the color in
the cheeks
Highlight, used to
draw attention to
the high points of
the face
Bronzer gives
skin a bit of color
and contours the
face for a sharper
definition or
creates a tan-look
Mascara, Eye
Shadow, Eyeliner,
Eyebrow Pencils
9. Mrs. Nisha Marcel
Pharmaceutics II CBCS 9
TYPES
Used to color the
fingernails and
toenails
Setting spray is
used as the last
step in the
process of
applying makeup
False eyelashes
are used when
exaggerated
eyelashes are
desired
Micellar waters
are becoming a
more common
product used to
remove makeup
10. Mrs. Nisha Marcel
Pharmaceutics II CBCS 10
• These cosmetics can be classified into 2 main groups : those which provides decoration & those which
suplement the natural functions of the skin.
• Key formulation ingredients: surfactants (ethylene glycol distearate, propylene glycol monostearate), waxes
(beeswax, ozokerite), fatty acid esters.
• Traditional formula of vanishing creams are
based on stearic acid.
• Stearic acid melts above body temperature &
crystallizes in a form so as to be invisible
providing a non-greasy film.
• Also imparts attractive appearance to the cream.
FORMULA: Vanishing Cream
Stearic acid 17.0 %
Potassium hydroxide 0.7 %
Glycerin 5.0 %
Water 100.0 %
Perfume & preservatives q.s.
11. Mrs. Nisha Marcel
Pharmaceutics II CBCS 11
• Deodrants : Inhibit or mask the odour formation caused by interaction of prespiration and bacteria.
• Antiprespirants : Work primarily to retard sweating by reducing the amout of prespiration excreted
from the eccrine sweat gland.
• In the United States, Canada, Australia and most of the Far East - including Japan antiprespirants
are classified legally as drugs because their action affects a body function, namely, eccrine
sweating.
• Formulated in number of forms: sticks, aerosols, extrudables (gels and soft solids), roll-ons, creams,
pump and squeeze sprays.
• 3 basic types of needs must be:
1. Control of underarms wetness
2. Elimination of underarm odour
3. Provision of an aesthetically pleasant application that doesnot whiten axillae or stain garments.
12. Mrs. Nisha Marcel
Pharmaceutics II CBCS 12
Raw materials for shampoo: surfactants, foam boosters & stabilizers, conditioning agents, special,
additives, sequestering agents, viscosity modifers, opacifying or clarifying agents, fragrances, colours,
preservatives.
• Concentrated CLEAR LIQUID SHAMPOO can be
prepared with more soluble monoethanolamine
lauryl sulphate. These shampoos maybe be diluted
and used.
• A good MILD SHAMPOO can be formulated with
detergents having good after-effects.
• Such detergents include methyl taurides,
amphoterics etc.
FORMULA
Monoethanolamine
lauryl sulphate
70.0 %
Coconut
diethanolamide
2.0 %
Water 100.0 %
Colour, perfume &
preservatives
q.s.
FORMULA
Lauryl amino propionic acid 12.0 %
Triethanolamine lauryl
sulphate
24.0 %
Coconut diethanolamide 2.0 %
Lactic acid (to adjust pH) q.s.
Water 100.0 %
Preservatives, perfumes,
colour
q.s.
13. Mrs. Nisha Marcel
Pharmaceutics II CBCS 13
• Includes : Eyeshadow, Mascara, Eyebrow Pencil, Eye Cream, Kajals
• Raw materials used: pigments, fats & waxes, gums, preservatives, perfume.
CREAM EYESHADOW
▪ An eyeshadow can be a liquifying cream or an
emulsion.
▪ Liquifying cream is prepared with fats and waxes.
▪ The formulation of this type include waxes and fatty
materials like beeswax, lanolin, petroleum jelly,
spremaceti, ceresin.
FORMULA I
Beeswax
(bleached)
4.0 %
Spermaceti 9.0 %
Lanolin
absorption base
15.0 %
Paraffin 72.0 %
FORMULA II
Beeswax 4.5 %
Cocoa butter
(odourless)
2.5 %
Spermaceti 7.0 %
Lanolin 7.0 %
Petroleum jelly 79.0 %
14. Mrs. Nisha Marcel
Pharmaceutics II CBCS 14
List of colourants used for Eye
cosmetics
Blue shade : Titanium dioxide (1 parts)
+ Ultramarine blue (6 parts)
Green shade : Titanium dioxide (4.5
parts) + Ultramarine blue (2.5 parts) +
Chromium oxide (15.0 parts)
Mauve shade : Carmine (1 parts) +
Titanium dioxide (4 parts) + Ultramarine
blue (2 parts)
Violet shade : Carmine (3 parts)
Titanium dioxide (9 parts) + Ultramarine
blue (11 parts)
Blue grey shade : Titanium dioxide (10
parts) + Ultramarine blue (12 parts) +
Chromium oxide (0.3 parts) + Iron
oxide, black/carbon black (0.3 parts)
• Fats & Waxes: Other important class of
raw materials which are used in eye
make-up preparations is fats & waxes.
• Some commonly used fats & waxes are:
- Petroleum jelly
- Ceresin wax
- Carnauba wax
- Beeswax
- Lanolin
- Stearic acid
- Isopropyl myristate
15. Mrs. Nisha Marcel
Pharmaceutics II CBCS 15
• Formulation ingredients for nail lacquers: film formers,
resins, plasticizers, solvents, pigments
CUTICLE
CREAM
FORMULA I
Stearyl dimethyl benzyl
amm. Chloride
1.5 %
Diethyl phthalate 2.0 %
Alcohol 7.0 %
Water 100.0 %
Perfume & preservative q.s.
FORMULA II
Lanolin absorption base 25.0 %
Mineral oil 15.0 %
Beeswax 3.5 %
Cetyl pyridinium chloride 1.5 %
Water 100.0 %
Preservative & Perfume q.s.
16. Mrs. Nisha Marcel
Pharmaceutics II CBCS 16
• Pigments are added to the lacquer base to
prepare final product.
• The concentration of pigments varies from
about 3 – 5 % in the final product.
• Usually the pigments are 1st dispersed by
milling in suitable vehicle & converted into
coloured chips.
• These coloured chips are dissolved in lacquer
base when required.
FORMULA I
Nitro-cellulose 18.0 %
Santolite 4.0 %
Dioctyl phthalate 5.0 %
Isopropyl alcohol 11.0 %
Ethyl alcohol 10.0 %
Butyl alcohol 10.0 %
Toluene 42.0 %
17. Mrs. Nisha Marcel
Pharmaceutics II CBCS 17
• Formulation of tooth paste: abrasives, detergents, foaming materials, humectants, binding agents, sweetening
agents, flavouring agents, preservatives, therapeutic agents.
• Formula I - calcium carbonate has been used as abrasive and gum tragacanth has been used as binding agent
in Formula II.
• Formula III, a part of calcium carbonate has been replaced with di-calcium phosphate & gum tragacanth is
replaced by sod. carboxymethyl cellulose.
FORMULA I
Abrasive 40.0 %
Detergents / foaming agents 1.50 %
Humectants 5.00 %
Binding agents 0.50 %
Sweetening & flavouring agents 0.50 %
Water 100.0 %
FORMULA II
Precipitated calcium chloride 42.0 %
Glycerin 30.0 %
Propylene glycol 3.0 %
Gum tragacanth 1.2 %
Saccharin sodium 0.05 %
SLS 1.3 %
Water 100.0 %
Flavour, preservative q.s.
FORMULA III
Di-calcium phosphate 30.0 %
Precipitated calcium carbonate 15.0 %
Glycerin 25.0 %
Saccharin sodium 0.05 %
Sod. Carboxymethyl cellulose 1.0 %
Water 100.0 %
Flavour, preservatives q.s.
18. Mrs. Nisha Marcel
Pharmaceutics II CBCS 18
• Baby: The skin of infants differ both histologically and physiologically in many respects. It
is less hairy, thinner, less cornified in infants. Safety of baby products is most important as
they lack resistance to bacterial infections. In view of these considerations as far as
possible the materials used should be harmless, non-toxic, non irritant.
• Elderly: The major changes on aging to the skin include dryness, wrinkles & laxity. It is
persumed that the above reason leads to less nutritional transfer resultig in small
proliferation. Cosmetics divided into 2 for face care & body care.
• Hypo allergenic: Those cosmetics which is applied to those products which are specially
designed for those who tend to be allergic to some ingredients of cosmetics that cause no
allergic reaction to normal users.
19. Mrs. Nisha Marcel
Pharmaceutics II CBCS 19
List of materials which have been reported causing reaction in some
individual
Acacia Orris root
Alizarin Pyrogallol
p- Aminophenol Potassium sulphite
Benzoin Quinine salts
Boric acid Resorcinol
Cocoa butter Rice powder
Corn starch Rosin
Gum Arabic Salicylic acid
Gum karaya Thymol
Gum tragacanth Wheat starch
Hexachlorophene Zinc formate
Methenamine Quinine salts
20. Mrs. Nisha Marcel
Pharmaceutics II CBCS 20
• A dime-sized patch of olfactory membrane in each of the upper passages of nose that contain nerve
endings which give us our sense of smell.
• NATURAL FRANGRANT MATERIALS:
1. Herbal fragrances: Neroli (Bitter Orange tree), Rose, Jasmine, Lavender, Cinnamon, Cloves, Chamomile,
Sandalwood, Frankincense, vanilla, Tobacco, Bergamot, Lime/Lemon, Cardamom.
2. Animal fragrances: Musk, Ambergris (Male sperm whale), Civet.
• METHODS OF PREPARATION:
1. Distillation
2. Solvent extraction
21. Mrs. Nisha Marcel
Pharmaceutics II CBCS 21
• Chemical the term soap refers to combination of fatty acids with alkalis (metallic bases).
• Raw materials for making soap: Fats & oils (coconut oil/palm oil/beef tallow/soybean oil), Alkalis (Caustic soda –
NaOH), Other additives – Water, Salt, Antioxidants, Whiteners, Perfumes, Pigments & Colours.
• Manufacture of soap – Semi-boiled Process & Cold Process, Full-Boiled Process.
• Other types of soaps:
1. Transparent soaps
2. Castile soaps
3. Superfatted soaps
4. Carbonated soaps
5. Deodorant soaps
6. Liquid soaps
7. Bathing Bars
FORMULA I
Soap base 99.3 %
Titanium dioxide 0.2 %
Perfume 0.5 %
Colour q.s.
22. Mrs. Nisha Marcel
Pharmaceutics II CBCS 22
• Aerosol Cosmetics: The success of aerosol packaging depends on its various constituents. Some products
which are commonly available in aerosol form are – Hair sprays, Deodorants & Antiperspirants, Fragrances,
Shaving cream.
• Cosmetic Patches: These are at the beginning stage of evolution though it represents a convenient, simple, safe
and effective way of cosmetic application. Types: pore cleansers, blackhead removers, face sheet masks.
Components of cosmetic patch: backing film, adhesive layer, release liner.
• Herbal cosmetics: These are products which are composed of cosmetic base containing plant materials like
extracts, tincture, distillates etc. Herbs are used in the form of infusions, decoctions, extracts & tinctures, flower
water, oil soluble extracts. Examples – Almond (Scrubs), Apple (Mask), Beet (Face wash), Cucumber (Soothing
gel), Fenugreek (Hair care), Jasmine (Bath oils), Lime (Soaps), Seaweed (Jellies)
FORMULA I
Herbal face mask
Aloe vera pulp
Almond meal
FORMULA II
Herbal rouge
Beet juice
Glycerin
23. Mrs. Nisha Marcel
Pharmaceutics II CBCS 23
• As per provision of Dugs & Cosmetics Rules, cosmetics are required to comply with the standards
laid down by the Bureau of Indian Standard (BIS), it is necessary to consult the Indian Standard IS
4707 (Part 1) & (Part 2) – Classification of cosmetics Raw Materials & Adjuncts.
• Under this standard, BIS has classified the ingredients for use in cosmetics into 2 categories:
1. Generally Recognised As Safe (GRAS)
2. Generally Not Recognised As Safe (GNRAS)
24. Mrs. Nisha Marcel
Pharmaceutics II CBCS 24
WATER
Most widely
used raw
material
2 source of
water & 2
source of
contamination
Purification
Methods for
Inorganic
Contaminates:
Ion Exchange
System,
Distillation,
Reverse
Osmosis
Microbiological
Purification:
Chemical
Treatment, Heat
Treatment, UV
Radiation,
Filtration,
25. Mrs. Nisha Marcel
Pharmaceutics II CBCS 25
▪ One of the most widely used raw materials in the manufacture of cosmetics is water.
▪ Water is extremely reactive substance. Four types of reactions take place in biochemical processes,
i.e. Oxidation, reduction, condensation & hydrolysis.
▪ Water is used as solvent for many ingredients of cosmetics.
▪ The water which is available from water mains contains traces of contaminations.
1. Water from urban areas contain inorganic traces like ammonia, phosphates, arsenates, borates,
chromium, zinc, beryllium, cadmium, copper, cobalt, nickel, iron, manganese & organic contaminants.
2. Water from rural areas contains inorganic ions like calcium, magnesium, sodium, potassium,
bicarbonate, sulphate, chloride, silicates.
▪ With purification the levels of these contaminants are brought to such limits as are not harmful to
human beings & animals.
26. Mrs. Nisha Marcel
Pharmaceutics II CBCS 26
▪ 2 types of contaminants should be consider if it is to be used in manufacture of cosmetics.
▪ Type 1 – Inorganic ions : a number of cosmetic products are emulsion. The presence of inorganic
ions such as Mg & Zn can interfere with the balance of static charges responsible for proper
functioning of some surfactants.
▪ Type 2 – Microbial contamination : The presence of micro-organisms would lead to development of
foul odour, visible colonies of bacteria, moulds or fungi.
Purification method to remove the
minerals from water include:
1. Ion-exchange system
2. Distillation
3. Reverse osmosis
Purification method to remove the micro-
organisms from water include:
1. Chemical treatment
2. Heat treatment
3. UV radiation
4. Filtration
27. Mrs. Nisha Marcel
Pharmaceutics II CBCS 27
• The purification assembly consists of 2 columns, one
column consist of cation resins (to absorb anionic
minerals) & the other column contains anion resins
(to absorb cationic minerals).
• Water form the mains is 1st passed through one
column & then through other column.
• Thus the cations & anions are removed & water
becomes free from inorganic ions.
• However these resins have limited capacity to bind
cations & anions . Therefore when their capacity is
exhausted, inorganic ions from water are not
removed & the water still contains the inorganic ions.
• This can be detected by conductivity meter as the
conductivity is directly proportional to inorganic ions
present in the water.
• When the conductivity is more than the
recommended for water free from inorganic ions,
inlet of water is stopped. Resins of these columns
are regenerated with strong mineral acid & sodium
hydroxide. After regeneration the resins become fit
for demineralization of water.
• De-ionised water on exposure to atmosphere
absorbs carbon dioxide & forms carbonic acid.
Therefore the pH of de-ionised water becomes
acidic on storage.
29. Mrs. Nisha Marcel
Pharmaceutics II CBCS 29
• In this process the water is heated & boiled which causes formation of steam.
• The steam thus produced is condensed & the produced water is collected.
• In-organic materials being non-volatile remain in the still & condense steam produces water free
from minerals.
• Distillation plants are more commonly used in pharmaceutical industry particularly by those units
which manufacture sterile products.
30. Mrs. Nisha Marcel
Pharmaceutics II CBCS 30
• In this process, feed water passes across & through membrane & is collected as purified water on the other side
of the membrane.
• About 75% of feed water is collected as purified water & 25% of it is continuously discarded as concentrate.
• In this process the nature & structure is of the membrane is of great importance to the efficiency of the process.
• The commonly used membranes are anistropic cellulose acetate & the hollow polyamide fibre.
• A typical cellulose acetate membrane consists of relatively dense non-porous layer which is also called as
‘active’ layer.
31. Mrs. Nisha Marcel
Pharmaceutics II CBCS 31
Chemical Treatment
• Ion-exchange resins & distribution systems can be
treated with dilute solutions of formaldehyde or
sodium hypochlorite.
• The usual practice is to leave the beds & distribution
systems with 1% solution of either chemical.
• This treatment will greatly reduce the number of
micro-organism in water that is passed through ion-
exchange system.
• Microbial count of stored water can be kept under
control by dosing it with small amount of either
formaldehyde or sodium hypochlorite.
Heat Treatment
• Heat treatment to deionised water is often given in
the process vessel itself in the cosmetic industry.
• An adequate quantity of water is transferred to the
vessel & water is heated to boiling & is held at this
temperature for at least 20 minutes.
• This treatment will destroy all water borne bacteria
except spore forming.
• In an alternate method the water is heated to 120°C
& then instantaneously cooled. This method is also
called as Ultra High Short Term (UHST) treatment.
32. Mrs. Nisha Marcel
Pharmaceutics II CBCS 32
UV Radiation
• UV radiation (below 300nm) are known to have
lethal effect on micro-organisms.
• Since the radiation of this wavelength do not
penetrate very far through water, water has to be
brought very close to the source of radiation.
• Efficiency of UV exposure to water goes down with
deterioration of UV radiation source.
Filtration
• Membrane filters of pore size 0.2μ or less are known to
retain bacteria.
• Though these filters can effectively remove bacteria but have
a number of drawbacks.
• Drawbacks are:
1. Running cost are very high
2. With gradual build up of micro-organisms in the filter
matrix, the resistance to flow increases to a point where
either the flow stops or some micro-organisms break
through membrane.
3. Some micro-organism like moulds are able to grow in filter
matrix and literally go through the other side of the filter.
• To monitor quality of purified water it can be tested to
pharmacopeial standards. Microbial limit of 100 CFU* per
1ml of water.
33. Mrs. Nisha Marcel
Pharmaceutics II CBCS 33
OILS
FATS
OILS WAXES FATS
• Triglycerides have
unsaturated fatty acids
1. Vegetable Oils: Almond,
Arachis, Castor, Olive,
Coconut, Jojoba oil.
2. Mineral oils: Light &
Heavy liquid paraffin.
• Base of many cosmetics
e.g. lipsticks
1. Bees wax
2. Spermaceti
3. Paraffin wax
4. Ceresin & Ozokerite wax
5. Microcrystalline wax
6. Carnauba wax
• Saturated fatty acid
glycerides.
1. Fatty acids
2. Fatty alcohols
3. Fatty acid esters
4. Lanolin & its
derivatives
5. Soft paraffins
34. Mrs. Nisha Marcel
Pharmaceutics II CBCS 34
• Oils from vegetable origin as well as mineral origin are used in cosmetics.
❑ Vegetable Oils:
i. Almond oil: it has emollient properties and is used in creams & lotions.
ii. Arachis (ground nut) Oil: its used in hair oils and brilliantines.
iii. Castor oil: it’s emollient. Generally used in lipsticks. Can also be used in hair oils, brilliantines, creams &
lotions.
iv. Olive Oil: olive oil is emollient & soothing. Its used in bath oils, creams & lotions.
v. Coconut Oil: It has odour of coconut .
vi. Jojoba oil: It gives on pleasant feeling on use and used in creams, milky lotions, lipsticks etc.
35. Mrs. Nisha Marcel
Pharmaceutics II CBCS 35
❑ Mineral Oils:
i. Light liquid paraffin: Has low viscosity. It is a mixture of liquid hydrocarbons. Colourless & odourless oily liquid.
Has Good spread. Used in bath oils, hair oils, brilliantines, lotions and creams.
ii. Heavy liquid paraffin: The composition of heavy liquid paraffin varies according to the source of petroleum
from which it has been obtained. Almost colourless oily liquid. Emollient in nature. It is used in creams, lotions,
brilliantines, hair oils, bath oils.
• Mineral oils are much more stable than vegetable oils .
• It is advisable to use 10ppm of tocopherol or butylated hydroxy toluene (BHT) as stabilizer.
36. Mrs. Nisha Marcel
Pharmaceutics II CBCS 36
❑ Beeswax : A secretion formed by the hive bee. It enables water to be incorporated and form w/o emulsion.
❑ Spermaceti : A solid wax obtained from mixed oils from the head, blubber & carcase of spermaceti whale.
Available as white to off-white translucent flakes with crystalline structure and pearly white luster.
❑ Paraffin Wax : Is a mixture of solid hydrocarbons, obtained by distillation from petroleum. It is colourless,
translucent wax like solid and slightly greasy to touch.
❑ Ceresin & Ozokerite Wax : Also known as Mineral wax & Purified Ozokerite. Obtained from purification of
ozokerite (naturally occurring solid paraffin). Colourless, odourless, crystalline wax.
❑ Microcrystalline Wax : Complex mixture composed of mainly of C31 – C70 isoparaffins. It has microcrystalline
structure. When mixed with other waxes prevents crystallization hence used in lipsticks.
❑ Carnauba Wax : Obtained from leaves of the Brazilian wax palm. It is one of the hardest wax.
37. Mrs. Nisha Marcel
Pharmaceutics II CBCS 37
• A variety of fatty materials are used in cosmetics are used in cosmetics.
• These materials may be from vegetable, animal or mineral origin.
❑ Fatty Acids: Fatty acids having carbon chain ranging from C12 to C18 have been used in cosmetic but stearic
acid is the fatty acid of choice. Commercially available stearic acid is a mixture of 55% palmitic acid & stearic
acid. The only other acids which is been used is oleic acid. Oleic acid is used to enhance pearl shine in lotions &
creams and also to overcome the problem of gel formation associated with stearates.
❑ Fatty Alcohols: Widely used in creams & lotions. Most commonly used fatty alcohols are cetyl & stearyl. Both
are used in the emulsions as emulsion stabilizers and are effective emollient.
❑ Fatty Acids Esters: Butyl stearate, isopropyl stearate, isopropyl myristate (Low molecular weight) have been
widely used in creams & lotions. These are oily in character & have low viscosity. Polyol esters of fatty acid are
also used in creams & lotions.
38. Mrs. Nisha Marcel
Pharmaceutics II CBCS 38
❑ Lanolin & its derivatives: it is a good emollient because of its hydrophobic and adhesive character. However
its use is limited upto 5% concentration as increased concentration leads to tackiness to the final product. It also
has emulsifying property (w/o emulsion).
• Lanolin alcohols are derived from lanolin. These are mixtures of alcohols which fall into 3 groups: sterols,
triterpene alcohols, aliphatic alcohols.
• Lanolin derivatives are used for cases hypersensitive to lanolin. Acetylated lanolin & propionyl lanolin derivative
are used in cosmetics.
❑ Soft Paraffins: purified mixture of hydrocarbons obtained from petroleum. They are emollient. Probably function
by covering the skin with a hydrophobic occlusive film which prevents water loss from skin thereby promoting
hydration.
39. Mrs. Nisha Marcel
Pharmaceutics II CBCS 39
• Plays an important role in emulsification process.
• Main objective is to form a condensed film around
the droplets of dispersed phase. Therefore the
concentration of the emulsifier should be sufficient
for forming the film.
• The film maybe monomolecular or multimolecular or
made of solid particles.
• Classifications:
1. Natural emulsifying agents:
- Monomolecular film forming e.g. Lecithin, cholesterol
- Multimolecular film forming e.g. Acacia, gelatine
2. Synthetic (surfactants): MOST COMMONLY USED
- Monomolecular film forming
- Anionics e.g. SLS, potassium laurate
- Cationics e.g. Ammonium bromide
- Non ionics e.g. Sorbitan fatty acid esters
3. Finely divided solids:
- Solid particles film forming
- Colloidal clays e.g. Bentonite, veegum
- Metallic hydroxides e.g. Magnesium hydroxide
40. Mrs. Nisha Marcel
Pharmaceutics II CBCS 40
Anionics
• In this group the surfactant ion possesses a
negative charge.
• Alkali soaps like potassium, sodium salts of
lauric, oleic & stearic acid are soluble in water
& are good emulsifying agents.
• Calcium, magnesium & aluminium salts of fatty
acids, also known as metallic soaps are water
soluble & produce w/o type emulsions.
• Soaps of fatty acids with organic amines like
triethanolamine produce o/w type emulsion.
• Sulphate alcohols & sulphonates are mainly
used as wetting agent but also have some
value as emulsifiers also. Sulphonates have
higher tolerance to calcium & do not hydrolyse
as readily as sulphates. The most commonly
used surfactant of this class is dioctyl
sulphosuccinate.
41. Mrs. Nisha Marcel
Pharmaceutics II CBCS 41
Non - ionics
• These are undissociated surfactants & are widely
used as surfactants.
• These emulsifiers are not susceptible to pH &
electrolytes.
• The most commonly used are:
- Glyceryl esters
- Sorbitan fatty acid esters
- Polyoxyethylene glycol esters
• List of auxiliary emulsifying agents:
- Agar, Bentonite, Cetyl alcohol, Glyceryl
monostearate
Cationic
• Surfactant ion of this group possesses positive
charge.
• Not widely used as anionics & non - ionics.
• Are valuable as they posses antibacterial property.
• Emulsions prepared using cations have pH within a
range of 4 to 6.
• This pH range being the pH of the skin, emulsions
made with cationics are good for skin.
• Cationics are weak emulsifying agents, therefore
often used with auxiliary emulsifying agents such as
cetostearyl alcohol.
42. Mrs. Nisha Marcel
Pharmaceutics II CBCS 42
• Cosmetic Thickeners and Natural Polymers add texture and help stabilize lotions and creams, and
also create a wide variety of different gels.
1. Xanthum gum: Xanthan gum is widely used because it is compatible with most ingredients used
in cosmetics and it’s readily available and versatile. This gum will create a gel that can tolerate the
addition of a wide range of water-soluble active ingredients.
2. Hydroxyethylcellulose (HEC): Is a nonionic natural polymer made from plant cellulose. HEC is
compatible with most other gums but works especially well with sodium alginate.
3. Acacia gum: Acacia gum is a naturally-occurring gum soluble in hot or cold water and gives a
clear solution of neutral to acidic pH. This gum is not a thickener unless used in concentrations
above 40%. It also pairs well with other gums to help stabilize formulations.
4. Sclerotium Gum: Is non-ionic thickener made from a fermented fungus. This versatile gum has
high thermal stability and can help to enhance the skin’s moisture barrier, preventing trans-
epidermal water loss and helping to keep the skin moisturized.
44. Mrs. Nisha Marcel
Pharmaceutics II CBCS 44
➢ A desire to buy cosmetic product is controlled by three senses: sight, touch, smell.
❑Pigment: White or coloured chemical compound which is insoluble in a particular solvent.
❑Dye: A chemical compound usually of coal-tar origin which is soluble in the vehicle to which the
reference is made. Either can be water soluble dyes or oil soluble dyes.
❑Lake: An organic pigment prepared by precipitating a soluble dye on either a reactive or absorptive
substratum / diluents.
❑Toner: An organic pigment which does not contain substratum / diluents.
45. Mrs. Nisha Marcel
Pharmaceutics II CBCS 45
Toluidine Red Toner :
pigment in context
with water & dye in
context with organic
solvents.
46. Mrs. Nisha Marcel
Pharmaceutics II CBCS 46
➢Colour can be defines as a visual
sensation caused by a definite
wavelength or a group of wavelengths by
an object by either emission, reflection,
refraction or transmission.
➢Visually colour can change in 3 ways.
➢According Munsell’s nomenclature there
are Hue, Value, Chroma.
Hue – Helps to distinguish a colour. Hue
tells whether a colour is Red Yellow Green
Value – A light colour is distinguished from
dark colour by value. Value indicates how
much light energy strikes the eye.
Chroma – Tells the intensity of the colour.
By this a strong colour can be
distinguished by weak colour.
47. • Solubilities of the order of 0.0001% are generally considered as insoluble. But sometimes a pigment in this order
of solubility imparts colour to the solvent. This phenomenon is called BLEEDING.
• Pigment is slightly shaken with a particular solvent in a test tube and the solvent is filtered.
• The colour of the filtrate is compared with the colour of the solvent.
• If the filtrate has changed noticeably in colour , it is termed as bleed.
Bleed Slight Bleed Non- Bleed Pseudo/Colloidal Bleed
Mrs. Nisha Marcel
Pharmaceutics II CBCS 47
48. • Are used to describe or compare visually the pigments
grounded in oil/ wax/ other suitable grinding materials.
• To compare colours the grounded colours are smeared on a
white paper side by side.
• When spatula is pulled down on a paper 1st a thick film is
formed & then a thin film is made.
• These films reveal colour differences.
• Appearance of thick film is called Masstone ot Toptone.
• Appearance of thin film is called Undertone / Skintone / Print
tone.
• When gorunded colour samples are mixed with white
pigment such as titanium dioxide, zinc oxide in the same
above conditions the results are described as reduction,
strength, tint or let down with white.Mrs. Nisha Marcel
Pharmaceutics II CBCS 48
49. Mrs. Nisha Marcel
Pharmaceutics II CBCS 49
1. NATURAL COLORS:
SAFFRON: It is dried stigma of flowers of the plants
Cross Sativus Linne. The principal colouring agent is
crocin, a glycoside. Crocin is a yellow powder easily
soluble in water.
CHLOROPHYLL: Occurs abundantly in nature. Green
colours to leaves is imparted by chlorophyll (acts as a
catalyst to photosynthesis).
COCHINEAL: Red dye stuff. It consists of dried bodies
of female insects Coccus cacti. Principal colouring
matter is carminic acid. Extracted from ground insect
mass.
2. INORGANIC COLORS:
ULTRAMARINE: The raw materials sulphur, soda ash,
china clay, charcoal are used to make ultramarine
colour. Depending on the proportions used blue & pink
shades are produced.
TITANIUM DIOXIDE: Commercially used anatose
form. It is used in all types of cosmetics because of its
inertness.
ZINC OXIDE: White pigment. It is brightness and low in
tinting strength. Extensively used in face powder.
50. 3. COAL TAR COLORS
Mrs. Nisha Marcel
Pharmaceutics II CBCS 50
• Rule 144 of the D&C Rules
prohibits use of coal tar colours
other than specified in Schedule
Q.
• Schedule Q colours should not
contain more than:
1. 2ppm of Ar
2. 20ppm of Pb
3. 100ppm of heavy metals
Common name
of the colour
Colour index
No.
Guinea Green B 42085
Tartrazine 19140
Sunset Yellow
FCF
15985
Ponceau 3R 16155
Amaranth 16185
Schedule Q – Part I
Colours to be used in cosmetics other than soap
Schedule Q – Part II
Colours permitted to be used in soap
Common name of the
colour
Colour index
No.
Iragalite Red 12075
Citrus Red No.2 12156
Aqueous Green Paste 74260
Monolite Red 4R 12420
Olive Red 3R 26105
51. Mrs. Nisha Marcel
Pharmaceutics II CBCS 51
• Prevents the spoilage of cosmetic products.
• 2 main reasons for spoilage of cosmetics: oxidation of oils & fats , microbial growth.
• Most of the cosmetics preparation are likely to deteriorate if preservatives have not been added. Water
promotes the growth of micro-organisms, therefore all cosmetics preparations containing water are susceptible
to microbial growth.
• Cosmetic preprations containing oils & fats are susceptible to oxidative reactions.
• In above view both Antimicrobial agents & Antioxidants are part of preservatives
52. Mrs. Nisha Marcel
Pharmaceutics II CBCS 52
• Sources of microbial contamination include raw materials, environment, equipment, packaging materials &
personnel.
• If microbes are allowed to multiply in finished cosmetics, they will utilize cosmetic ingredients for their growth &
the metabolite produced interferes with the ingredients present leading to spoilage of product.
• According to survey - Used cosmetics are found contaminated with staphylococci, diphtheroids, fungi & yeast. In
unused cosmetics, pseudomonas were most frequently present.
• An ideal preservative must ossess the following attributes:
1. Compatible with formulation
2. Solublity to obtain effective concentration
3. Stable to provide sustained anti-microbial effect.
4. Colourless & odourless
5. Non-toxic, non- irritant or non- allergenic in concentrations used.
53. • Factors affecting
effectives of
Antimicrobials:
1. Dissociation & pH
2. Concentration
3. Susceptibility of organism
4. Interference by
ingredients of cosmetics
Preservatives which are used in
Cosmetics & Pharmaceutical
Preparations
Inorganic Acids
Benzoic acids
Salicylic acid
Formic acid
Sorbic acid
Alcohols
Ethyl alchol
Isopropyl alcohol
Chlorbutanol
Aldehydes Formaldehyde
Phenolic
compounds
Cresol
Phenol
Mercury
compounds
Thiomersol
Nitromersol
Surface active
agents
Benzalthonium
chloride
Miscellaneous Vanillin
Mrs. Nisha Marcel
Pharmaceutics II CBCS
53
54. Mrs. Nisha Marcel
Pharmaceutics II CBCS 54
• Fats and oils which have unsaturated linkage which are prone to oxidative deterioration.
• Rancidity is the term w.r.t. Oils and fats.
• Natural antioxidants (tocopherol) are destroyed during refining.
• Factors affecting rancidity:
1. Presences of pro-oxidants (Oxidase)
2. Oxygen
3. Moisture
4. Light
5. Heat
6. Micro-organisms
55. Mrs. Nisha Marcel
Pharmaceutics II CBCS 55
• Classification of Antioxidants:
1. Phenolic type: Gallic acid, Mathyl gallate, Ethyl
gallate, Amyl gallate, Butylated Hydroxy Toulene
(BHT).
2. Quinone type: Tocopherols, Hydroxy chromans.
3. Amine type: Ethanolamine, Lecithin, Purines,
Glutamic acid.
4. Organic acids, alcohols & Esters: Ascorbic acid,
Citric acid, Oxalic acid, Tartaric aicd, Sorbitol,
Mannitol.
5. Inorganic aicds & their salts: Sodium sulphite,
sodium metabisulphite, Phosporous acid & their
salts
• Choice of Antioxidants depends on the following
points:
1. The nature of fat/oil present as ingredient of
cosmetics
2. The physical form of cosmetic
3. pH of cosmetic
4. Intended use of cosmetic
5. Expected shelf-life of cosmetic
6. Conditions of storage
56. Mrs. Nisha Marcel
Pharmaceutics II CBCS 56
• Perfumery is an industry itself.
• Floral composition and specialities are often used in the perfume formulation.
• Steps for compounding perfumes:
1. Selection of aromatic raw materilas
2. Selection of floral composition and specialities
3. Dosification of all aromatics of variables strength
4. Addition of the floral absolutes
5. Dosification of tinctures
57. • When you smell a perfume 1st you encounter the top notes,
followed by middle notes then the base notes.
• Base note - e.g. Sandalwood, Balsam.
• Middle notes - light, spicy, green, rosy, narcotic, fruity, precious.
• Top notes – vaporizes rapidly, sharp.
• Accessory notes are certain fragrant materials such as ambrette,
civet which when added add their pronounced frangrance & also
alter the other ingredients unpredictably.
Mrs. Nisha Marcel
Pharmaceutics II CBCS
57
NOTES:
Base
Middle/Heart
Top
Accessory
59. Florals: characterised by dominance of floral essences
Green, Fresh, Ambery
Orientals: composed most intense spies
Ambery, Spies
Chypres: often include patchouli with top notes of citrus
Green: sharper than florals calling mind to
meadows, green grasses & leaves.
Pine, Basil, Rosemary
Citrus: composed of orange, lemon, grapefruit.
Citrus, Orange, Lemon, Herbal, Anise
https://www.fragrancex.com/blog/fragrance-wheel/Mrs. Nisha Marcel
Pharmaceutics II CBCS
59
60. Mrs. Nisha Marcel
Pharmaceutics II CBCS
60
• The psychology of fragrance selection :
1. Research has led to several theories about the physical and psychological factors which influence selection of
a particular perfume.
2. A new viewpoint based on rich classical literature (Corbin, 1984) focuses on the relationship between a
person's personality and his or her choice of fragrances.
3. The physiological basis of the senses and, in particular, human odour memory are of particular interest. Smell
is the only sense which has direct contact with the brain.
4. Extroverted perfume users, who looked for stimulation, had a significant (5% level) tendency towards fresh
fragrance notes.
5. Introverted women had a tendency (5% level) towards oriental notes.
6. Emotionally ambivalent perfume users were significantly (5%) more fascinated with floral-powdery notes.
7. Emotionally stable perfume users showed no significant tendency towards anyone specific kind of fragrance
note.
https://link.springer.com/chapter/10.1007/978-94-009-1215-1_10
63. Mrs. Nisha Marcel
Pharmaceutics II CBCS 63
1. STABILITY OF BASE FORMULA & ITS TESTING (General preservation test: Temperature preservation
test , Photo stability test, General performance and effectiveness tests)
2. STABILITY OF FUNCTIONAL AGENTS
3. STABILITY OF MASS PRODUCED COSMETICS (Variation of manufacturing conditions, filling
conditions, quantity produced)
4. STABILITY BASED ON USAGE ENVIRONMENT (Soaps & cleansers, sunscreens, Aerosols, cosmetics
containing strong solvents, hair colouring pdts.)
64. • Temperature preservation test : The cosmetics are stored at different temperatures, & observations are made
in the different properties of cosmetics. Parameters observed are : Changes in external appearance, changes in
fragrance, physiochemical properties (pH, hardness, viscosity, turbidity, etc.)
• Photo stability test : Cosmetics are often exposed to light of varying degree particulary during window display.
For this a cosmetic can be subjected to outdoor(sunlight) exposure test, inside (artificial light) exposure test &
fluorescent light exposure test.
• General performance and effectiveness tests : Other parameters which maybe observed during the general
performance test include:
1. Skin care cosmetics: changes in texture, changes in lasting quality, covering power, applied colour, adhesion,
lasting quality, water resistance.
2. Cosmetics for nails: changes in adhesion, luster, drying speed, colouring ability, water & oil resistance.
3. Cosmetics for hair: changes in setting & weaving ability, effect on hair luster, effect on hair removal ability.
Mrs. Nisha Marcel
Pharmaceutics II CBCS 64
65. • This method of evaluation not only indicates stability of base formulation but also indicates the stability of
functional ingredients. Some typical accelerated tests are :
1. Temperature and humidity combination test: In these tests cosmetics is stored at predetermined temperature
& humidity. Range of temperature & humidity could be 37-50 ℃ and 75-98% respectively.
2. Cyclical temperature tests: In tese tests temperature is changed cyclically every day e.g. low-high-low-high-
low-high, to stimulate changes in temperature.
3. Stress test : This test has been desined taking into considerations the overall stress & time period of actual
usage. typical methods are - Centrifugation seperation method, Vibration test, Drop test, Load test, Friction
test.
Mrs. Nisha Marcel
Pharmaceutics II CBCS 65
66. • Some functional materials are easily degraded by atmospheric oxygen. For example, vitamins (A, B1, B2, B6, C).
Generally , upper & lower limits of 110% to 90% are stated for functional materials.
• There may be some materials which maybe incompatible with cosmetic base or an ingredient of cosmetic base.
• Other maybe affected by the changes in pH.
• Stability of these materials can be predicted on the basis of accelerated test methods.
• The products maybe stored at different temperatures for predetermined period and then analyzed for the
contents of functional material.
Mrs. Nisha Marcel
Pharmaceutics II CBCS 66
67. • Sometimes problems are encountered during large production of cosmetics.
• The problems encountered may be separation of two phase, change in viscosity, change in colour shade, etc.
• Points to be considered while scaling up production:
1. Variation in the lots of raw materials
2. Variation in manufacturing conditions
3. Variation in filling conditions
4. Quantity produced
Mrs. Nisha Marcel
Pharmaceutics II CBCS 67
68. • The stability of the cosmetic must match the anticipated usage requirements.
• For this it should be taken into considerations how the consumer actually uses the product.
• Some examples are given:
1. Soaps & cleansers: these may become soggy / have reduced viscosity / become unusable due to immersion
in water.
2. Sunscreens: may stain clothes & difficult to remove.
3. Bath preparations: may cause damage to bath tubs or may stain towel with plant extracts, may be accidently
ingested or get access to the eyes.
4. Aerosols: solvents in aerosol may have adverse effect on household goods or gases may leak out due to
misuse.
5. Cosmetics containing strong solvents: can damage spectacles, combs, sponge.
6. Hair colouring products: may stain hands, towels & bath room fittings.
• Thus when considering the stability of cosmetics, consideration should also be given to phenomena which relate
to usage environment.
Mrs. Nisha Marcel
Pharmaceutics II CBCS
68
69. Mrs. Nisha Marcel
Pharmaceutics II CBCS 69
• Manufacturing of cosmetics should be carried out in clean & hygenic conditions.
• IS: 11377-1985 Guidelines on Hygeine Manufacture of Cosmetics state that is expected that bacterial count of a
cosmetics should not exceed 1000 micro-organism per 1gm. These standards also state that there should not
be any pathogens.
• Standards o some cosmetics prescribe total microbial countthat should not be exceeded. For examples;
1. Skin creams - NMT 1000 micro-organism per 1gm
2. Lipsticks - NMT 100 micro-organism per 1gm
70. Mrs. Nisha Marcel
Pharmaceutics II CBCS 70
• Control of microbial contamination requries attention to various points.
• Salient points to which attention should be paid to control microbial contamination of cosmetics are:
1. Control of environment of manufacturing premises
2. Control of personal hygiene of operators
3. Development of an effective cleaning & sterilization programme
4. Monitoring of quality of water
5. Adherence of strict microbiological criteria for raw materials
6. Use of adequate preservatives
7. Monitoring of microbiological quality of cosmetics during manufacturing stage
71. Mrs. Nisha Marcel
Pharmaceutics II CBCS 71
• Large number of micro-organisms in a cosmetic can spoil it.
• Changes may occur in colour, odour or consistency.
• Sometimes there could be visible growth of micro-organisms, tarnishing the reputation of cosmetic brands.
Therefore adequate measures should be taken to control microbial contamination.
S.No. Cosmetics Indian Standards Microbial Limits
1 Tooth pastes IS 6356 : 2001
Total viable count per
gram - max 1000
pathogens per gm -
Absent
2 Hair oils IS 7123 : 1993
Microbial examination -
NMT 100 MO / gm
3 Face pack IS 15153 : 2002
Total viable count per
gram - max 1000
Gram negative
pathogens per gm - <
10
4 Kajal IS 15154 : 2002
Total viable count per
gram - max 100 Gram
negative pathogens
per gm - < 10
72. Mrs. Nisha Marcel
Pharmaceutics II CBCS 72
• Environment in which cosmetics aare manufactured is one of the sources of contamination.
• The other soucrces of contamination include equipemnts, raw materials & personnel.
• The contamination from the following sources should be minimized:
1. Environment
2. Equipment
3. Raw materials
4. Personnel
• Monitoring of the microbial load
73. Mrs. Nisha Marcel
Pharmaceutics II CBCS 73
1. Environment:
• The potential of contamination from environment is significantly reduced with the control of environment in the
manufacturing area.
• To control environment, the building where cosmetics are manufactured should have certain features: the floors
should be made of impervious material, should be smooth & free from cracks. The walls should be washable.
the drains should have air vents. The construction of the building should be such as that it prevents the
entrance and harbouring of vermin, birds & pests. The building should have appropriate air - control facilities
suitable to the operations to be carried out.
74. Mrs. Nisha Marcel
Pharmaceutics II CBCS
74
• The following steps will keep the enivronment clean & will bring down microbial count:
1. Floors in manufacturing area should be washed everyday, walls should be washed periodically & should be
mopped with antiseptic solution.
2. Drains should be kept covered.
3. Air ducts, light fitting & other piping should be cleaned periodically.
4. All areas in building should be well lit & ventilated
5. Apart from manufacturing areas, other areas such as stores, laboratories should be kept in neat & tidy
conditions.
6. All dirt, debris & waste material should be removed as soon as possible.
7. Cleaning equipments shoulde be kept clean.
8. Manufacturing areas should be fumigated occasionally with formaldehyde vapours. (Vrosil Pharma - based on
Hydrogen Peroxide)
9. The factory clothings should be used and clothing should be put on before entering the manufacturing areas.
10. Manufacturing areas should be cleaned & sanitized as per schedule & SOPs.
81. Mrs. Nisha Marcel
Pharmaceutics II CBCS 81
❑ Hazard v/s Risk
❑ Safety evaluation: control of recognized
hazards to achieve an acceptable level of
risk. Determines whether the product is under
normal condition of use .
❑ Types of risk
❑ Sources of risk
82. Mrs. Nisha Marcel
Pharmaceutics II CBCS 82
Hazard
• Potential to cause injury
• No relation to does /exposure
Risk
• The safety assessment of polyacrylamide and
acrylamide residues in cosmetics
• https://pubmed.ncbi.nlm.nih.gov/16154914/
83. Mrs. Nisha Marcel
Pharmaceutics II CBCS
83
1. Hazard Identification:
• Identify the causes
• Physiological chemical data
• Quantitative structure activity relationship
(QSAR) is a strategy of the essential
importance for chemistry and pharmacy,
based on the idea that when we change
a structure of a molecule then also the
activity or property of the substance will
be modified.
• Invitro & invivo studies
• Epidemiological studies measure the risk
of illness or death in an exposed
population compared to that risk in an
identical, unexposed population (for
example, a population the same age,
sex, race and social status as the
exposed population).
2. Dose Response
Risk characterisation
Risk management
Risk communication
- Safe dose with negligible /
acceptable risk
3. Exposure assessment:
➢ Duration of contact
➢ Percutanoeus absorption
➢ Interferences within products
➢ Frequency of use
➢ Body surface location
➢ Route of exposure
➢ Rinse off / leave on products
➢ Concentration in products
➢ Quantity applied
85. Mrs. Nisha Marcel
Pharmaceutics II CBCS 85
1. Unsuitable ingredient use: Unsafe substances e.g. mercury in skin whitener – 10x concentration – impaired
vision, no coordination.
2. Inadequate microbial quality management: contamination with pathological germs such as S.aureus,
P.aeruginosa
3. Traces of banned substances: Lead in lipsticks (infertility, memory loss), Formaldehyde in shampoo.
4. Unwanted interactions between ingredients: pH change, precipitation of substances, smell, texture, colour.
86. Mrs. Nisha Marcel
Pharmaceutics II CBCS 86
• EU Cosmetic regulation 1223/2009
• FDA Cosmetic Act (Title 21)
• Preservative Efficacy Testing (PET)
• Trends
• Challenges
87. Mrs. Nisha Marcel
Pharmaceutics II CBCS 87
• USP 51/ EP 7
• Candida albicans, E.coli, P.aeruginosa, S.aureus
• Microorganisms are either harvested by centrifugation from broth culture / by washing surface growth from a
solid medium into sterile vessel.
• Innoculum size 10+8 CFU/ml adjusted using optical density & calibration curve.
• Determined by Plate count & serial dilution method.
89. Mrs. Nisha Marcel
Pharmaceutics II CBCS 89
TRENDS
- Use rapid detection method: culture based
(colorimetric test), Non culture based (ATP
bioluminescent test),
CHALLENGES
- Challenge future products by repetitive inoculation,
longer incubation, , new preservative system which are
safe.
90. • In ATP Bioluminescence Technology, an ATP meter and an ATP swab are used to detect ATP on
surfaces, used to detect hygiene level in water used in food processing industry and drinking water.
• ATP Bioluminescence meter detects extremely low levels of organic contamination.
• Adenosine Triphosphate, or ATP, is the energy molecule found in all living things, making it a perfect
indicator when trying to determine if a surface is clean or not.
• Allows QC microbiology group to quickly confirm the presence or absence of microbial contamination
faster than traditional methods using an automated, reagent-based assay. Whether testing at critical
production process steps, screening incoming raw materials and water, or for final product release
testing.
Mrs. Nisha Marcel
Pharmaceutics II CBCS 90
92. • Sensorial analysis is the examination of a product through the evaluation of the attributes
perceptible by the five sense organs (organoleptic attributes) such as colour, odor, taste, touch,
texture and noise.
• It is used in diverse fields like cosmetics, food, personal care products, textiles etc. The Consumer
Acceptance Tests, Difference Tests and Descriptive Tests are the three types of sensory analysis.
• The analysis is carried out in two phases: the first test uses common naïve assessors followed by
the second phase employing well trained assessors.
• In the cosmetic industry sensory evaluation data has been used as a part of marketing decision. It is
acknowledged to be a powerful approach in optimizing product preference.
Mrs. Nisha Marcel
Pharmaceutics II CBCS *
93. • Sensorial analysis is used to evaluate the consumer acceptance of the cosmetic; especially for
products of general topical use.
• Sensorial analysis data plays an integral role in the marketing decision.
• The results are reproducible but the complexity and high costs limit their use in the field of research
and development of new products rather than the routine use in monitoring processes and quality
control.
• Sensorial analysis consists of three subsections.
1. Effective testing: It is concerned with obtaining “objective facts” about the products which could
range from basic discrimination testing to descriptive profiling. It requires a trained panel.
2. Affective testing: Also known as “consumer testing” and deals with obtaining subjective data. It
employs a panel of untrained personnel.
3. Perception: It involves the biochemical and psychological theories related to animal and human
sensations which help to explain why certain characteristics are preferred over others.
Mrs. Nisha Marcel
Pharmaceutics II CBCS
*
94. • The study methodology consists of two phases:
• Phase 1: After having used the product under study, a questionnaire is being completed by each
trained panellist and includes parameters for evaluation of product sensory characteristics and for
the “subjective evaluation of skin characteristics” after application (redness, itching etc.)
• Phase 2: In this phase, normal untrained consumers are asked to use the product and answer the
questionnaire based on the same parameters as described above .
• Based on the feedback after phase 1, suitable formulation adjustments are made and phase-1b is
subsequently carried out wherein the modified formulation is again tested on the same panel.
Mrs. Nisha Marcel
Pharmaceutics II CBCS
*
95. Advantages
• Sensory panels help manufacturers, scientists, food technologists etc.
gain a clear perception of what ordinary consumers may experience
• Sensory panel testing can be much more rapid than most non sensory
methods
• Sensory panellists use more than one sense, making them more
flexible instruments
• Sensory panellists can be very sensitive and good at detecting minute
differences in product characteristics
• Sensory panels are acceptable for writing into specifications for quality
• Laboratory facilities are not required to conduct the descriptive
analysis of a product. This makes sensory panels a feasible
proposition to study products
Disadvantages
• Sensory panellists can become fatigued with the entire process of
testing and assessing descriptive data.
• Assessors may be partial or biased due to loss of interest.
• To ensure precision in the analysis and interpretation of the descriptive
data, several assessors may be required making it an expensive
proposition.
• The entire process of recruiting and training sensory panellists can be
a time-consuming and costly process.
• It may not be easy to replace assessors quickly as the incoming
assessor will have to be given intensive training to develop requisite
expertise of the job.
• The sensory panel method can be more expensive than some non-
sensory methods.
• The panellists may not be good at quantifying perceptions.
• Interpretation of results may get problematic and be open to dispute.
Mrs. Nisha Marcel
Pharmaceutics II CBCS
*
96. • “Cosmetic” means any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or otherwise applied
to, the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the
appearance & includes any article intended for use as a
component of cosmetic.
• Why you require a Regulation for Cosmetics????
Mrs. Nisha Marcel
Pharmaceutics II CBCS *
99. I – GENERAL REQUIREMENTS
• Location & surroundings
• Buildings
• Water supply
• Disposal of water
• Health, clothing & sanitary requirements of the staff
• Medical services
• Working benches
• Adequate facilities – washing & drying containers
II – REQUIREMENTS OF PLANTS &
EQUIPMENTS
• Powders
• Semi solids
• Nail lacquers
• Lipsticks
• Depilatories
• Preparations used for eyes
• Aerosol
• Alcoholic fragrances
• Hair dyes
• Tooth pastes & powders
• Toilet soaps
Mrs. Nisha Marcel
Pharmaceutics II CBCS *
100. II – REQUIREMENTS OF
PLANTS & EQUIPMENTS A. Face powders, cake makeup, compacts, face packs,
masks & rouges – EQUIPMENT
B. Creams, lotions, emulsions, pastes, cleansing milk,
shampoos, pomade, brilliantine, shaving creams &
hair oils
C.Nail polishes & lacquers – EQUIPMENT,
PREMISES, STORAGE, MANUFACTURE, OTHER
REQUIREMENTS
D.Lipsticks & lip gloss – EQUIPMENT
E. Eyebrows, eyelashes, eyeliners, kajal, surma
A. Powders
B. Semi solids
C.Nail lacquers
D.Lipsticks
E. Depilatories
F. Preparations used for eyes
G.Aerosol
H.Alcoholic fragrances
I. Hair dyes
J. Tooth pastes & powders
K. Toilet soaps
Mrs. Nisha Marcel
Pharmaceutics II CBCS
100
101. • Standards for cosmetics in finished forms : the following cosmetics in finished form shall conform to the Indian
Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS).
1. Skin powders
2. Skin powders for infants
3. Tooth powders
4. Toothpaste
5. Skin creams
6. Hair oils
7. Cologne
8. Kumkum powders
9. Cosmetic pencils
10. Liquid toilet soaps
Mrs. Nisha Marcel
Pharmaceutics II CBCS *
102. Part I – List of dyes, colors & pigments
permitted to be used in Cosmetics & soaps
Common Name Color Index No.
Guinea Green B 42085
Tartrazine 19140
Sunset yellow FCF 15985
Ponceau 3R 16155
Toney Red 26100
Orange G 16230
Acid Red 89 23910
Naphthol Blue Black 20470
Part II – List of colors permitted to be used in
Soaps
Common Name Color Index No.
Phthalocyanine Blue 74060
Iragalite Red 12075
Citrus Red No.2 12156
Monolite Red 4R 12420
Oil Red 3R 26105
Aqueous Green Paste 74260
Iragalite Carmine 12490
Mrs. Nisha Marcel
Pharmaceutics II CBCS *
103. • The Bureau of Indian Standards (BIS) is the national
Standards Body of India working under the aegis of
Ministry of Consumer Affairs, Food & Public
Distribution, Government of India. It is established by
the Bureau of Indian Standards Act, 1986 which
came into effect on 23rd December 1986.
• It is a comprehensive building code for regulating the
building construction activities across the country.
• The main objective of the proposed legislation are:
To establish the Bureau of Indian standards(BIS) as
the National Standards Body of India.
Mrs. Nisha Marcel
Pharmaceutics II CBCS *
BIS (Bureau of Indian Standards)
specifications
Activities:
• One of the major functions of the
Bureau is the formulation, recognition
and promotion of the Indian
Standards.
• Product Certification - Product
Certifications are to be obtained
voluntarily.
• Management System Certification:
1. Quality Management System
Certification Scheme IS/ISO 9001.
2. Environmental Management System
Certification Scheme IS/ISO 14001.