The Skin

The skin completely covers the body and is continuous with the membranes lining the
body cavities. Structure of the skin.
There are two main layers of the skin.
a. Epidermis
b. Dermis
Between the skin and underlying structures there is a layer of subcutaneous fat.

A. Epidermis:
It is the superficial layer of the skin and is composed of stratified epithelium which
varies in thickness different parts of the body. It is thickest in the palms of the hands
and soles of the feet. There is no blood vessels and reserve endings in the epidermis.
From outside to inside stratified epithelium may be divided into five layers.
1. Stratum corneum: It is most superficially placed. The cells are keratinized.
2. Stratum lucidum: This is a thin and more or less transparent in appearance.
3. Stratum granulosum.
4. Stratum spinosum: This is a broad layer of variable thickness and is made up of
polyhedral cells.
5. Stratum germinativum: This layer is composed of single layer of columner
epithelium. At the junction of epithelium and the dermis, there occur a number
of branched cells, known as melanocytes.

B. Dermis:
This layer is also called the true ‘skin’. It is made up of connective tissue and
lies below the epidermal layer. It is made up cherty of collagenous and elastic Fibre.

Cells of the dermis:

a. Fibroblasts from which the fibrous issue of the dermis develops.
b. Cells belonging to the reticulo-endothelial system which protects the body from
invading bacteria. Some of these cells are load with melanin pigments known as
melanophores.
c. Areolar tissue of the other regions of the body.

Blood vessels of the dermis:

Capillary blood vessels mainly. They play a vital role in temperature regulation.
There is also a well-organized lymphatic system in the dermis.

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Nerves of the dermis:
Vasomotor nerve, Sensory nerve endings of various types keep the individual
informed about the surroundings.

Muscles of the dermis:

a. Arrectores pilorum: a small bundle of involuntary muscle.
b. Tunica dartos and other voluntary muscles.

PIGMENTATION OF THE SKIN

The color of the human skin is derived from a number of chemical and physical
properties associated with the skin structure. Five pigments are known to influence skin
color.
a. Melanin: It is a yellow to black pigment which is formed mainly in stratun,
malpighi and is formed on a specific cell particle, the melanosome within the
melanocytes. It contributes color to the skin and protects from un-radiation.
b. Melanoid: It is supposed to be the degradation product of melanin and is
diffused through the epidermis.
c. Carotene: It is a yellow-orange pigment and is present in lipid-rich areas (i.e,
stratum corneum and the fat of the subcutaneous tissue).
d. Oxyhaemoglobin: It imparts reddish hue to the skin and is evident in areas rich
in blood supply i.e. Face, neck palms etc.
e. Reduced haemoglobin: It contributes a bluish or purple color to the skin.
The distribution pattern and concentration of these pigments also influences the skin
color to a great extent.

FUNCTION OF THE SKIN

a. Protection: Stratum corneum- protects injury and bacterial invasion.
b. Regulation of body temperature.
1. Cutaneous vasoconstriction: diminishes heat loss
2. Cutaneous vasodilation: facilitates heat loss
3. Sweating.
c. Generalized sensation.
d. Excretion.
e. Synthetic function: synthesis of vitamin D.
f. Secretion: Sebum and sweat.

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 g. Absorption.
h. Water balance.
i. Acid-base equilibrium.
j. Storage functions.

FORMATION OF MELANIN IN THE SKIN

Melanins are high polymers with color ranging from brown to black and are
widely distributed in plants and animals. Melanin is mainly composed of CNHO.
Sometimes S and Fe are also present.
Melanin pigmentation takes place in the epidermal melanin unit which is
defined as a melanocyte surrounded by a constillation of malpighian cells. The number
of melanosomes produced and the rate of their transfer to the malpighian cells are
regulated by hormones and UV-radiation but primarily due to the genetic factors.

CHEMICAL SEQUENCE OF MELANIN FORMATION

Phenyl alanine → Tyrosine → DOPA → Dopaquinone → Leucodopachrome
→ Dopachrome → 5,6- Dihydroxyindole → 5, 6 → Indolequinone → Melanin.

EpiDermis containing melanocyte --------- UV light ---------- Melanin.

FUNCTIONS OF MELANIN
1. Protective action against sunlight in the skin is the principal function of the
melanin.
2. Another function of melanin in the choroid coat is to convert the eye-ball in a
perfect black chamber.

MECHANISM OF DEPIGMENTATION
1. By selectively destroying or decharacterizing melanocytes.
2. By interfering with the bio-synthesis of melanin and its precursors.
3. By inactivating or preventing the biosynthesis of the enzyme Tyrosinase.
4. By interfering with the transfer of melanin granule to malpighian cells either by
inhibiting the phagocytosis of melanocyte dendrites or by causing intracellular
oedema.
5. By changing the melanin present in the melanosome from dark to light dark.

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 CREAMS

Cream is a perfect semisolid stable emulsion system which is generally oil in

water (o/w) and water in oil (w/o) type. The water in oil (w/o) type emulsion is called
cold cream and the oil in water (o/w) type semisolid emulsion is called vanishing
cream.

Cream performs the following functions-

1. Supply oil to the skin: keeps the skin smooth and soft.
2. Gives an oily protective covering on the skin: control water evaporation and
maintain water balance.
3. The oil content of the cream imparts a polishing effect on the skin.
4. It removes to some extent water or oil soluble impurities.
5. It also gives some additional function.
a) Acts as an emollient
b) Acts as a base for application of certain drug
c) Acts as a base for application of make up foundation.
d) Acts as skin brightening.

There are different types of cosmetic creams-

1. Cold cream
2. Vanishing cream
3. Barrier cream
4. Cleansing cream
5. Moisturizing cream
6. Deodorant cream
7. Foundation cream
8. Hair cream
9. Hand cream
10. All purposes cream, etc.

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 COLD CREAM
Cold cream is nothing but a perfect semisolid stable w/o emulsion system. The
main ingredient of cold cream is oil and it constitutes the largest portion in cold cream
formulation. In winter, the dry environment drags water from the skin and the skin
becomes dry and rough. Cold cream gives on oily protective covering on the skin and
thus water content cannot evaporate out.
In cold cream -
Oil remains 40 to 70%
Wax or spermaceti remains 5 to 15%
Water remains 20 to 35%

THE CONTENT AND THEIR FUNCTIONS IN COLD CREAM

FORMULATION
1. Oil:
Oil gives an oily protective covering on the skin which controls water
evaporation. Oil keeps the skin smooth and soft.
There are different types of oily materials-
A) Hydrocarbon oils and waxes:
- Mineral oil or liquid paraffin
-White soft paraffin
-Ozokerite
-Squalene
-Patrolatum
B) Triglyceride esters:
-Vegetable and animal fat and oils (palm oil, clove oil, olive oil, pea nut oil etc.)
C) Lanolin Derivatives:
-Lanolin oil, lanolin wax.
D) Fatty alcohol:
-Lauryl alcohol
-Cetyl alcohol
-Stearyl alcohol
-Cetostearyl alcohol
-Myristyl alcohol
-Lanolin alcohol

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E) Wax esters:
-Lanolin, beeswax, spermaceti, myristyl myristate.
F) Vegetable wax:
-Carnauba wax.
Range: 30 to 50% or more or as required.

2. Emulsifying agent:
Na-borate is used as emulsifying agent. It gives opaque white appearance and
also has antiseptic property. If transparent cold cream is required, other emulsifying
agent than sodium borate should be used.
Borax is also used in cold cream to neutralize the wax acids.
Naturally emulsifying agents are generally not used, because they contain
oxidative enzyme and cause oxidation. Furthermore, natural emulsifying agents are
prone to microbial contamination.
So, to overcome this problem, synthetic emulsifying agents such as anionic,
cationic and nonionic may be used in cream formulation.
Anionic emulsifying agents are: Sodium Lauryl Sulphate Potassium Stearate,
Sodium Stearate, Sodium Cetyl Sulfate Cationic emulsifying agents’ salt.
Non ionic emulsifying agents are:
Tween series (water soluble)
Span series (oil soluble)
The orders of emulsifying agents to be used are:
Non ionic> Anionic> Cationic
Sometimes blends of emulsifying agents are to be used and in that case a
calculation of HLB value is necessary to constitute a stable cold cream.

3. Moisturizing Agents:
Moisturizing agents or humectants are the agents that control the moisture
exchange between the product and air, both in the jar and on the skin.
They are hygroscopic substances-
Purpose:
1. Moisturizers prevent water loss by evaporation from the cream and thus
maintain the water content of the preparation.
2. It absorbs moisture from the atmosphere. It also gives a protective coating on
the skin so that water can not evaporate from the skin.
3. It provides easy application of the cream on the skin.
4. It helps in smoothing the skin, as they have the polishing property.

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Example:
Glycerin, Propylene glycol, Sorbitol, etc.
Glycerin produced creams have the hardest consistency
Sorbitol produced creams have medium hardness
Propylene glycol produced creams have the softest consistency.
Some drawbacks of glycerin:
 Warm feeling due to capillary dilation.
 Adhesion of dust particles due to stickiness.
 Sweetening effect.
Range: Upto 30% or as required.

4. Antioxidant:
Antioxidant should be used because of the presence of oil phase. Oil phase is
very susceptible to oxidation caused by atmospheric oxygen. The vegetable and animal
oil and fats as well as waxes undergo rancid and gives an unpleasant odor. So
antioxidants are used to minimize and retard the development of rancidity.
Examples:
 Butylated hydroxy Anisole (BHA)- 0.02-0.5%
 Butylated hydroxy Toluene (BHT)- 0.02-0.5%
 Ethyl gallate Propyl gallate.
 Tocopherol.
 Sorbic acid
 Na metabisulfite.
Among them BHA is the most commonly used, but it is little bit.

5. Preservatives:
Preservatives are used to prevent microbial contamination and to kill microbes.
Examples:
 Methyl paraben: 0.1-0.2%
 Ethyl paraben: 0.1-0.2%
 Propyl Paraben: 0.05-0.1%
 Butyl Paraben: 0.02-0.05%
Sometimes fungus growth is observed in the oil phase and a preservative, which is
used both in water and oil phase is used. Propyl paraben is used for this purpose,
because it is soluble both in oil and slightly in water phase.

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 Sometimes mixed preservative should be used, one of which is more water
soluble and another is more oil soluble Thus methyl, ethyl, butyl paraben are added to
water phase and propyl paraben is added to oil phase.
Benzoic acid sodium benzoate, sorbic acid, potassium sorbate and sodium
propionate are effective in acid media only.

6. Perfumes:
The choice of perfume for use in cream is based on esthetic value.

7. Purified water:
Water forms the internal phase in cold cream. It also acts solublizer of different
ingredients. In cold cream, water remains 20 to 35% or as required.

THE IMPORTANT QUALITY OF COLD CREAM

1. Consistency or viscosity:
The cold cream should have optimum consistency: neither very hard nor very soft.
The consistency of cold cream can be adjusted by changing the amount of wax or
paraffin.
If too hard, add paraffin oil (liquid paraffin)
It too soft, add wax or white soft paraffin.

2. pH:
The pH of cream should be within the physiological range i.e. near to that of skin pH
should be within 4.2-4.8.

3. Appearance:
The cream should be attractive and aesthetic.
It should not be turbid. Turbidity should be adjusted by non ionic surfactant.
Oily appearance of the cream must disappear after application on the skin i.e. the cold
cream must not provide a greasy look after application on the skin.

4. Slip:
Cold cream should not be sticky and have slippery or slip property which helps easy
rubbing and well distribution on the skin surface.

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5. Penetration/Absorption:
The penetration of cold cream through epidermis of the skin is desired.
Penetration of cream helps to keep the skin soft penetration is particularly important
when drugs are incorporated into the preparation.

6. Degree of emolliency:
Skin becomes soft by the absorbing water from the penetration after application. This
emollient effect provided by cold cream should be very fast so that a hard dry skin can
swell up and become soft in very short time. Emollient effect is mainly due to the
presence of Lanolin or its derivatives, cetyl alcohol, spermaceti.

7. Cooling effect:
Cold cream should give a cooling sensation to some extent after application on the skin.
The effect is mainly due to evaporation of some water from the preparation. Glycerin
generally reverses the situation, because it produces warm effect when applied. So the
percentage of glycerin should be strictly controlled in the cold cream preparation.

TYPICAL FORMULATION OF COLD CREAM

Ingredients Quantity (gm)

Spermaceti 10
White soft paraffin 5
Cetyl alcohol 1
Lanolin 5
Mineral oil 50
Sodium Borax 0.5
Butylated Hydroxy Anisole 0.5
Tween 80 3
Span 20 2
Perfume 9.5
Water 23

Justification:
a. Spermaceti is a naturally occurring wax like compound obtained from whale. It
constitutes the oil phase of cold cream.
b. White soft paraffin is the oil phase of cold cream. It develops the consistency of
cold cream.
c. Cetyl alcohol is also the oil phase and develops the consistency of cold cream.
d. Lanolin is oil phase of cold cream and acts as emollient.

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 e. Mineral oil is liquid paraffin. This is oily in nature and constitutes the oil phase
of cold cream.
f. Sodium borate acts as emulsifier and it also gives a opaque white appearance. It
acts as antiseptic.
g. Butylated Hydroxy Anisole acts as antioxidant.
h. Tween 80 and span 20 also act as emulsifier.
i. Water constitutes water phase. The water should be purified and should be free
from dust and mineral.

ANOTHER FORMULA OF COLD CREAM

Ingredient Quantity (gram)
White soft paraffin 7
Spermaceti 10
Lanolin 5
Liquid paraffin 50
Sodium Borate 0.5
Purified water 27.5

MANUFACTURING PROCEDURE OF COLD CREAM

Step-1: Spermaceti and white wax is melt at 700C in a beaker. Care should be taken
because higher temperature may evaporate or burn up some constituents of these waxy
components. Longer heating should also be avoided.
Step-2: Now the mineral oil is poured in the liquid mixture of spermaceti and white
wax. It is stirred well for a homogeneous mixture at 700C.
Step-3: In a separate beaker, purified water is taken and Na-borate is added to it with
continuous mixing at the same temperature.
Step-4: Now water phase is poured gently into the oil phase with continuous stirring at
700C.
Temperature is maintained at 700C because two phases can easily be mixed at this
temperature and the dispersion of water phase can easily be done.
Steam jacketed vessel should be used in order to keep the temperature control precise.
Mixing order affects the appearance of cold cream. Grossly the following steps are
followed in the preparation of cold cream:
- Preparation of oil phase
- Preparation of water phase
- Addition of water phase to oil phase
- Milling of cream if necessary
- Filling and packaging
- Marketing.

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 THE CONTENTS AND THEIR FUNCTIONS IN A COLD CREAM
FORMULATION
Purified water:
- For w/o emulsion.
- Forms the internal phase of the emulsion.
- Acts as a solvent for different contents.

Oil:
- Chemically inert oil should be used, eg: petroleum and paraffin.
- Constitutes the oil phase of the system.
- Gives protective coverings on the skin control water evaporation.

Emulsifying agent: (as required 1-2%):

Na-borate is used as an emulsifying agent. It gives opaque white appearance and also
has anti-septic property. It transparent cold cream is required, other emulsifying agent
than Na-borate should be used.
(Up to 30%)

Hydrocarbon oils and waxes:

Mineral oil
Petrolatum
Soft paraffin
Ozokerite
Squalane

Triglyceride esters: Vegetable and animals fat and oils.

Fatty alcohols: Lauryl, myristyl, cetyl, stearyl, lanolin alcohol.
Lanolin derivatives: Lanolin oil, Lanolin wax.
Fatty alcohol esters: Ethoxylated lauxyl, cetyl, stearyl, lanolin alcohol.
Wax esters: Lanolin, bees wax, spen maceti, myristyl myristate, stearyl stearate.
Vegetable wax: Carnauba wax.

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MANUFACTURING PROBLEMS AND THEIR REMEDIES: FACTORS TO BE
CONSIDERED DURING THE PREPARATION OF COLD CREAM

1. Formation of oil/water pocket: (Mixing order)

Oil/water pockets are formed generally on the surface of the cold cream.
Cause:
1. Improper mixing
2. Insufficient use of emulsifier
3. Unprecised control of temperature.
Remedy:
1. Proper mixing order.
2. Adding non-ionic surfactants eg. Tween or Span.
3. Increasing temperature.
Proper mixing and mixing order is critically important to achieve a quality cold cream.
The mixing should be continued even after the preparation of cold cream. Stirring
direction is also important factor governing the appearance of cold cream.

2. Phase separation: (Emulsifying agent)

Cause:
1. Swelling of Borax
2. Decreasing of mixing temperature.
3. Improper selection of emulsifying agent.
Remedy:
1. Increasing the mixing temperature.
2. Adding good w/o emulsifying agent and mixing properly.

3. Presence of waxy granules: (During cooling process)

Cause:
It cooling of the mixed ingredients is very rapid, particularly just after emulsification is
completed, crystallization of the higher melting waxes may occur which gives a gritty
feelings.
Remedy:
Cooling process should be very slow and the emulsified cold cream should be cooled at
its own pattern.

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4. Effect of heat, temperature and evaporation: (Problems associated with cold
cream consistency)
A. Loss of water from the w/o emulsion system in the cold cream due to evaporation
during stirring and heating causes hardening of cold cream.
Remedy:
Extra water can be added before mixing provided that amount of water loss is predicted
accurately. Usually 3-5% extra water is added.

B. Formation of repulsive smell or burning smell and colored sports.

Cause:
1. Heating at elevated temperature
2. Prolonged heating.

C. Sometimes cold cream becomes brown, yellowish or black spots are observed in
cold creams. This is due the heating of the oil phase at elevated temperature.
Remedy:
1. Precise control of temperature during manufacturing of cold cream.
2. Both oil and water phase should be mixed at the same temperature (700C).
3. Steam jacketed vessel should be used during the manufacture.

5. Decrease in intensity of fragrance and perfume:

Perfume oil is added in the oil phase and aromatic water is added to the water phase.
During heating perfume may partially be destroyed. So perfumes should be added to
the cold creams during cooling of the contents to get the best effect.

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