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CONTENTS:
Theory of emulsions
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The term “thermodynamics” was coined by William Thompson (Lord Kelvin) in year
1749.Itcomes from the Greek words: thermo (heat) and dynamics (power).The name heat-power
is appropriate because thermodynamics explains the conversion of heat into power by steam
engines. Thermodynamics in context of cosmetics reflect the stability and elegance of the
conditions. There are some basic laws of thermodynamics which are described as:
If two systems are in thermal equilibrium with a third one, they are also in thermal equilibrium
with each other. Systems are assumed to be in thermal equilibrium with each other if
spontaneous molecular thermal energy exchanges between them do not lead to a net exchange of
This is the fundamental laws of nature and is based on the principle of conservation of energy.
The first law of thermodynamics states that during an interaction, energy can only change from
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one form to another, neither created nor destroyed but the total amount of energy remains
constant.
Energy has quality as well as quantity, and actualprocesses occur in the direction of decreasing
isinvolved. The thermodynamically stable cosmetic preparations are considered to be the stable
ones. It is discussed below in reference to the emulsion because various cosmeceuticals are
Theory of emulsion
In ancient time, there was a paradox as “water and oil can’t mix” but the concept of emulsion
demonstrated that these two phases- aqueous and oily, can be mixed very well to form stable
formulation. It has been known for many centuries that emulsion was used for cosmetics
and health-care markets. The reasons for popularity of emulsion include incorporation of both
polar and non-polar materials in the same formulation. Earlier, emulsion technology has been
associated with skin care products, but now the application of emulsion has become much wider.
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Currently, hair conditioners, antiperspirants, color cosmetics and cleansing products are also
Emulsion can be defined as mixture of two or more immiscible liquidsor it can also be
defined as a two phase system which is consisting of two immiscible or partially miscible liquids
in which one is dispersed in another as very fine droplets. These two phases are oil and aqueous
system. The term emulsion was coined from Latin word for “to milk” as milk is an emulsion of
fat and water with many more ingredients. Emulsion is mainly categorized in two categories
Oil in water type: In which discrete droplets of oil are dispersed in water.
Water in oil type: In which discrete droplets of water are dispersed in oil.
In addition to these two classes of simple emulsion, some more complex systems are also there
(W/O/W). These newer classes offer greater degree of formulation flexibility with more
efficacious and pleasant cosmetic products. As emulsions are thermodynamically unstable, the
emulsifier is added to stabilize the emulsion system. Emulsifier stabilizes the system by forming
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Of late, there are advanced classes of emulsion namely microemulsion and nanoemulsion with
Many theories have been given to explain the stabilization of emulsion by the emulsifier. At
present, there is no single theory that can be applied universally to all emulsions. Rather, there
are different theories namely electric double layer theory, phase volume theory, hydration theory
of emulsions, oriented wedge theory, adsorbed film and interfacial tension theory to justify the
The first theory for the electrical double layer was given by Gouy and Chapman. DL is a
structure which appears onto surface of an object when it is exposed to a fluid. It refers to the
parallel layers of charge surrounding object. The first layer is of surface charge(positive/
negative), comprises of ions adsorbed onto the object due to chemical interactions. Second layer
is made up of ions that are attracted to the surface charge via the Coulomb force. The second
layer is associated with object. It is composed of free ions which move in fluid with the influence
these forces increases with increase in surface charge density (or the electrical surface
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potential).For unequally charged objects and eventually at shorter distances, these forces may
also be attractive. The theory ofDerjaguin, Landau, Verwey, and Overbeek (DLVO) combines
such double layer forces together with Van der Waals forces in order to estimate the actual
According to this theory there is an interaction between infinite homogenously charged wall
(described by surface charge density σ) and infinite electrolyte solution extending on one side of
the wall. Ions of the electrolyte are described by point-like charges of both signs in water
medium (which is defined by the permittivity constant ε). According to this model the electric
potential function and the corresponding average charge distribution are computed in the
neighborhood of the charged surface. The layers of two oppositely charged ions, known as
Helmholtz double layer, are not confined just to emulsions but to all boundary. The electric
charge is a key factor to be considered for the stability of emulsions which is stabilized with
emulsifying agents.
If spheres of the same diameter are packed as close as possible, one sphere will touch 12 others
and the volume that spheres occupy is about 74% of the total volume. Thus if the spheres or
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drops of the dispersed phase remain rigid it is possible to disperse 74 parts of the dispersed phase
in the continuous phase, but if the dispersed phase is increased to more than 74 parts of the total
volume, a reversal of the emulsion will occur. However, the dispersed phase does not remain
rigid in shape but the drops flatten out when they come in contact with each other. Moreover, all
the dispersed particles are not of the same size; therefore, it is possible for the dispersed phase to
Fischer and Hooker stated that hydrated colloids make the best emulsifiers. Fischer stated that
hydrophilic colloid when water and oil emulsions are concerned. Put another way, oil cannot
This theory has been given from the work of Langmuir and Harkinsfor the manner in which
emulsions are stabilized. It is based upon the concept that the molecules of the emulsifier orient
themselves at the interface between the dispersed and continuous phases, forming a wedge like
structure, the curvature of which determines the size of the dispersed phase. It explains the
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emulsion formation on the basis of selective solubility of surfactant. Surfactant possesses a polar
and non-polar group. It orients itself in such a way that the polar group faces water and non-
It is probably the most universally accepted theory for the formation of emulsions. This theory
has been developed or rather extended from earlier theories. According to this theory,
emulsification is influenced by the mass of the emulsifying agent, the ease with which this agent
is adsorbed at the interfacial separating surface, and the nature of the ions adsorbed by the
resultant film.
According to this theory, the emulsifier is deposited upon the surface of the droplets of the
dispersed phase in the form of plastic monomolecular film. This film prevents contact and
coalescence of the dispersed liquid. Actionof the emulsifier is purely mechanical and does not
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Fragrance selection
applied to a person’s body to make the person more attractive is defined as a cosmetic under the
law. Some examples of fragrance products that are regulated as cosmetics include Perfume,
Fragrance ingredients are also commonly used in other products, such as shampoos, shower gels,
shaving creams, and body lotions etc. Even some products labeled “unscented” may contain
fragrance ingredients which might react with active ingredients. This is because the manufacturer
may add just enough fragrance to mask the unpleasant smell of other ingredients, without giving
the product a noticeable scent. Some fragrance products that are applied to the body are intended
for therapeutic uses, such as treating or preventing disease, or affecting the structure or function
of the body. Products intended for this type of use are treated as drugs under the law, or
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Aromatic scents: It consists of fragrances from aromatic plants. They are widely used in
aromatherapy and herbal medicine and currently their popularity in high-end perfumery has been
increased as well. These days, perfumes rarely belong to a single olfactory group.
Aromatic perfumes: These are made up of various herbs, e.g. rosemary, basil or thyme.
Aquatic perfumes: They have a base of synthetic ingredients that evoke the sea, mountain air or
Citrus/fruity perfumes: This includes bergamot, grapefruit, lemon, mandarin, sweet orange and
fruits such as peach, red berries, watermelon, etc. Example: Dior Addict 2.
Floral perfumes: They contain flower extracts, such as rose, lily or jasmine. Example: Pure
Poison (Dior).
Green perfumes: This is formerly known as chypre, are made of bergamot, labdanum, patchouli
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Gourmand perfumes: They consist of vanilla and tonka bean, chocolate or caramel. Example:
Delices (Cartier).
Oriental perfumes: These have a base of amber, musks, vanilla and other exotic plants.
Woody perfumes: These are made of woods such as cedar, patchouli, sandalwood and vetiver.
The prime purpose of testingcosmetic products is to ensure a new or tailored product meets the
proposed physical, chemical and microbiological quality standards and aesthetics when stored at
activity should not become economically disproportionate. Every year, each manufacturer may
have their disposal tests that are adapted according to their activity. Each manufacturer must
design their stability testing program such as it should be reasonable and efficiently addresses the
cosmetics preparation is put at different environmental conditions for a set period of time. These
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conditions vary in temperature and light levels and are meant to simulate what will happen to the
Good Manufacturing practice as described in 21 CFR part 211 is applicable to all over the
counter (OTC) and prescription drug products and can be applied to cosmetics, in some ways,
Testing protocol
At selected intervals, evaluation of samples is required for various physical, chemical and
performance characteristics to see how they have changed. If the changes are found minimal
according to standards, then it is said to have “passed” stability testing. This means that the
cosmetic preparation has good stability and it will be stable for the duration of testing period.
The underlying assumption in stability testing is that increasing storage temperature speeds up
the aging reactions. A simple handy thumb rule is that a sample stored at 45 ºC for 8 weeks is
equivalent to one that is stored at room temperature for a year. This isn’t an exact predictor, but
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Due to extensive variety of cosmetics and their inherent complexity, “standard” stability tests
may not be prescribed. Manufacturers, who have depth knowledge of their products and
packages, need to modify testing protocols and to make a sound scientific basis to assess product
stability. Specific tests should be performed in order to predict possible alterations in the product,
to be at par with new/unusual technologies, and to be able to provide extended shelf lives to the
product.
New prototypes: Whenever we make a new formula and are satisfied with the way it performs,
New raw materials: Whenever we have to change the fragrance, color, or other raw material in
a formula, we have to assess its stability to make sure there aren’t any unacceptable changes.
Also, when we have a new raw material source (or supplier), stability testing is required.
formulas. This often means to change some order of addition or shorten mixing time. Whenever
changes like this happen, it could affect the formulation time. This further requires to run a
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New packaging: Cosmetic products require diversified types of packaging and their materials.
Paper, glass, metal and plastic material are generally used for cosmetics packagingand the global
market basically utilizes bottles, tubes, jars, containers, sticks, pumps, dispensers, roller balls,
caps and closures etc. for packaging purpose. Whenever the package is new, then it has to be
checked that the formulation is compatible with the container. Stability testing further ensure the
parameters.
There are no set rules on how to conduct a stability test for cosmetic products. Of course, for
cosmetic OTC products like sunscreens, or dandruff shampoos, FDA has specific stability test
requirements that have to be followed. Some basic procedures are described that can be followed
based on the number of samples that will be used for the stability testing. Usually, it’s a
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The glass jars are filled with the product along with the finished package. In stability
testing, both glass and packaging are subjected to testing if possible. The number of
samples depends on how much testing is to be done but at minimum we should have 2
Initial readings are noted. Once we have a sample filled, it is tested for all the
characteristics we are going to evaluate later. The exact tests depend on the particular
product but minimally physical characteristics such as appearance, color and fragrance
are recorded. The viscosity and pH measurements are also performed. For aerosol
Samples are put in different conditions. Stability testing requires different temperature
and light conditions. Some standard temperatures include 50 ºC, 45 ºC, 37 ºC, 25 ºC,
(RT), and 4 ºC. A freeze/thaw stability test is also conducted which involves cycling
conditions involve a fluorescent light box and a natural light box (to simulate sunlight).
8, 12 , and 52 weeks. Only the RT, 37 ºC and 4 ºC samples will be evaluated after one
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year. The highest temperature samples and the light exposed samples need to be
evaluated for the first three test intervals. The evaluation tests should be the same ones
Lastly, stability is determined. After 8 weeks we can confidently decide whether the formula is
stable or not.
I. Physical and chemical integrity tests which evaluate color, odor/fragrance, pH value,
II. Microbiological stability tests which evaluate the degree of contamination with bacteria,
III. Packaging stability tests which evaluate the packaging of the product.
Various approaches are described to predict how cosmetics will resist common stresses as higher
temperature and light. Generally manufacturers determine whether to perform such testing based
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on vulnerabilities of cosmetics product and its predictable shipping, storage display and use
stability. Various companies conduct their high temperature testing at 37 ºC (98 ºF) and 45 ºC
(113 ºF). If a product is stored at 45 ºC for three months (and exhibits acceptable stability) then it
should be stable at room temperature for two years. Evidently, the product must be stored at 25
Cycle Testing: The product should pass three cycles of temperature testing from -10ºC (14ºF) to
25 ºC (77ºF). The product is placed at -10 ºC for 24 hours and at room temperature (25 ºC) for 24
hours. This comprise of one complete cycle. If the product passes three such cycles then it can be
said that the product has a good degree of confidence in the stability. An even more rigorous test
is a -10 ºC to 45 ºC five-cycle test. This puts emulsions under a remarkable stress and, if it passes
the test, it indicates that the emulsion exhibits very high stability.
Centrifuge Testing: The dispersed phase (of an oil-in-water emulsion) has a tendency to
separate and rise to top of the emulsion as oil droplets. This phenomenon is called creaming.
Creaming is one of the first signs of impending emulsion instability and this should be taken
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seriously. Centrifugation is a good test method to predict creaming of emulsion. Wherein, the
emulsion are heated to 50 ºC and then centrifuged for 30 minutes at 3000 rpm. After
centrifugation, the resultant product is inspected for creaming. This test is necessary for the
Light Exposure Testing: Both formulas and packaging can be sensitive to the UV radiation. All
products must be placed in glass and the actual package, in the window and if its available a light
box that has a broad-spectrum output. Another glass jar totally covered with aluminum foil is
placed in the window to serve as control. Frequently, we will see significant discoloration of the
product and sometimes of the package also. This discoloration might be due to fragrance or some
other sensitive ingredient. Usually all that is needed is the addition of a UV absorber (e.g. 0.1%
of benzophenone).
Mechanical Shock Testing: In order to determine shipping damage of the cosmetic and its
packaging, mechanical shock testing is often conducted. Vibrational testing (e.g. on a pallet
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Monitoring: For all of the above mentioned tests, the color, odor / fragrance, viscosity, pH
value, and, if available, particle size uniformity and/or particle agglomeration should be
Microbial contaminants generally come from two different ways, firstly during production and
filling and secondly through the use of the cosmetics by consumers. From initial, the cosmetic
Microbial preservation is essential to make sure microbial safety of cosmetics for consumers,
maintain the quality of the product, and confirms hygienic and high-quality handling.Therefore,
it is necessary to carry out routine microbiological analysis of each batch of the finished product.
Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans are considered as the
main potential pathogens in cosmetic products. These specific potential pathogens must not be
detectable in 0.1 g or 0.1 ml of a cosmetic product. The parameters examined, the criteria and
methods used, and the results obtained per batch should be well documented.
Screening Tests: There are various simple testing kits available in the market (e.g. dip-slides or
plate counts) which provide quick and semi-quantitative results whether a cosmetic product is
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significantly contaminated or not. Sampling and evaluation of the results is simple and can be
Quantitative Tests: Quantitative tests determine the actual count level of bacteria, mold and
yeast. These tests are very sophisticated and laborious and can be performed only by qualified
microorganisms from cosmetic products comprise direct colony counts and enrichment culturing.
Packaging Stability Tests: Packaging may directly affect finished product stability because of
interactions which may occur between product, the packages and external surroundings. For
example, product constituents may be absorbed into the container or may chemically react with
the container. In addition, the container may not fully protect the product from adverse effects of
atmospheric oxygen and/or moisture or volatile product constituents (e.g. fragrances) may
Glass Tests: Glass is the most inert material and does not react with a cosmetic product in any
way. For this reason all testing should be done in glass and the actual packaging. In this way it
can be determined that whether the cause of product failure is the formula or the package.
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Weight Loss Tests: To determine evaporation (water loss through the container wall or closure
gaps) weight loss evaluation is one of the most important tests that must be conducted. This
testing (performed in the actual package with the cap torqued to 100% of target torque) is done at
room temperature and at 45 ºC for a period of three months. The weight loss should not exceed
Leaking Tests: It is desirable to test the finished packaged product in different orientations
(upright, inverted, on its side, etc.) to determine whether the packaging may leak (especially
during transport).
Cosmetics are the products which are applied to human body for cleansing, beautifying, and
making the skin more attractive and pleasing. The purpose of using cosmetic products is to
maintain the body in a good condition, protect it from the effects of the environment and aging
processes, alteration in appearance, and to improve the body smell. Cosmetic products are widely
used by every socioeconomic class of human beings to cleanse, perfume, protect, and change the
appearanceof skin. Consumer’sassumption is that the cosmetic products are safer and pose no
risk to the human health, but the actual scene is different. A number of complaints have been
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filed and various regulatory bodies have found that sometimes the ingredients which are used to
make formulations were not safe. A number of chemicals are usually added to cosmetics
preparations as preservatives and fragrances, lots of them are found toxic and prohibited from
usage as ingredients becausetheycan cause cancer, mutation, reproductive toxicity, and endocrine
disruption. Studies conducted by the Environmental Defense in Canada revealed that heavy
metals such as lead,arsenic, and antimony were found as ingredients which were not listed on the
product label. These ingredients may be from raw materials and/or from processing methods.
also foundincosmetic products. Astudy from Nigeria also indicated an elevated level of lead in
After these findings many countries have taken steps towards regulations of cosmetic products
and a committee has been coined to see the cosmetics product for its toxicity. All this led to
“Campaign for Safe Cosmetics”. It was the result of sincere efforts of educational, religious,
labor, women's, environmental and consumer groups with a goal to protect the health of
consumers and workers. It propels the health and beauty industry to make clear the use of
chemicals which are linked to cancer, birth defects and other health related problems and
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substitute them with suitable alternatives. It was started in 2002 with the release of a report, "Not
In this context, environmental and public health groups contacted with a laboratory to test 72
brand, off-the-shelf beauty products for the presence of phthalates and the laboratory testing
found the presence of phthalates in nearly¾th of the cosmetic products tested. Furthermore, the
chemicals that were used in these formulations were not listed on any of the labels. A second
In February 2003, the European Union passed a new amendment to their Cosmetics Directive
that prohibits the use of known or suspected carcinogens, mutagens and reproductive toxins
(CMRs) from cosmetics. This amendment came into force in September 2004.
In 2004, members of the Campaign for Safe Cosmetics and more than 50 other organizations
signed a letter asking cosmetics companies and personal care product companies to sign the
Campaign for Safe Cosmetics (Campaign for the Global Production of Safer Health and Beauty
Products), a pledge to remove toxic chemicals and replace them with safer alternatives in every
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The purpose of this act was to ensure, all personal care products should be free from harmful
ingredients. Because existing laws, which were not been significantly updated since 1938, had
many loopholes, and allow use of chemicals linked to cancer, birth defects, learning disabilities
and other health related problems.The cosmetics industry was facing serious problems because
beauty products, shampoos, and lotions etc. were contaminated with toxic chemicals like cancer-
causing formaldehyde in baby shampoos, lead in lipsticks and mercury in skin creams. The Safe
Cosmetics and Personal Care Products Act of 2013 gave the beauty industry a much-needed
make-over.
Safe Cosmetics and Personal Care Products Act of 2013 proposed the following:
To substitute ingredients that are linked to cancer, birth defects and others developmental
harm.
To close labeling loopholes by providing full ingredient list on labels and company
websites also.
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To share the data for avoidance of duplicative testing and promote the other alternatives
to animal testing.
To provide sufficient funding for the FDA Office of Cosmetics and Colors so that it has
Industrial network
regulatory anomaly and an excellent success.No industry in the history of the United States has
ever made a greater assurance to self-regulation or has been more successful in achieving it than
the U.S. cosmetic industry. Protecting industry image entails the maintenance of favorable
consumer perceptions of safety levels in order to achieve steady retail sales. The cosmetic
industry is sensitive to the image of an uncontrolled market where anything goes. They counter
entails ensuring adequate industry safety levels in order to avoid the need for increased federal
regulation which would externally impose more stringent requirements upon the industry. Thus,
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the cosmetic industry since the 1960s or so has relied on self-regulation, particularly in times of
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