Creams

Introduction
Creams are the topical preparations which can be applied on the skin. Creams are
defined as “viscous liquid or semi-solid emulsions of either the oil-in-water or water- in-oil type”
dosage forms which consistency varies by oil and water. Creams are used for cosmetic purposes
such as cleansing, beautifying, improving appearances, protective or for therapeutic function.
These topical formulations are used for the localized effect for the delivery of the drug into the
underlying layer of the skin or the mucous membrane. These products are designed to be used
topically for the better site specific delivery of the drug into the skin for skin disorders.
Creams are considered as a pharmaceutical product as they are prepared based on
techniques developed in the pharmaceutical industry; unmedicated and medicated creams are
highly used for the treatment of various skin conditions or dermatoses. Creams can be ayurvedic,
herbal or allopathic which are used by people according to their needs for their skin conditions.
They contain one or more drugs substances dissolved or dispersed in a suitable base. Creams may
be classified as o/w or w/o type of emulsion on the basis of phases. The term ‘cream’ has been
traditionally applied to semisolid formulated as either water-in-oil (e.g.: cold cream) or oil- in-
water (e.g.: vanishing cream).

Creams for application to mucous membranes such as those of the rectum or vagina
are also used. Creams may be considered pharmaceutical products as even cosmetic creams are
based on techniques developed by pharmacy and unmedicated creams are highly used in a
variety of skin conditions (dermatoses). The use of the finger tip unit concept may be helpful in
guiding how much topical cream is required to cover different areas.
Creams are semisolid dosage forms containing more than 20% water or volatile
components and typically less than 50% hydrocarbons, waxes, or polyols as vehicles. They may
also contain one or more drug substances dissolved or dispersed in a suitable cream base. This
term has traditionally been applied to semisolids that possess a relatively fluid consistency
formulated as either water-in- oil (e.g., cold cream) or oil-in-water (e.g., fluocinolone acetonide
cream) emulsions. However, more recently the term has been restricted to products consisting of
oil-in- water emulsions or aqueous microcrystalline dispersions of long-chain fatty acids or
alcohols that are water washable and more cosmetically and aesthetically acceptable.
Topical Drug Delivery
Over the last decades the treatment of illness have been accomplished by administrating drugs to
human body via various roots namely oral, sublingual, rectal, parental , topical, inhalation etc.Topical
delivery can be defined as the application of a drug containing formulation to the skin to directly treat
cutaneous disorder or the cutaneous manifestations of a general disease (eg. psoriasis) with the intent
of containing the pharmacological or the effect of drug to the surface of the skin or within the skin
semisolid formulations in all their diversity dominate the system for topical delivery, but foams, spray ,
medicated powders, solutions and even medicated adhesive systems are in use.

Advantages of topical drug delivery system:

 Avoidance of first pass metabolism.

 Convenient and easy to apply.

 Inconveniences of intravenous therapy and of the varied conditions of absorption like
Ph changes presence of enzymes gastric emptying time etc.

 Achievement of efficacy with lower total daily dosage of drug by continuous drug input.
 Avoid fluctuation of drug levels inter and intra patent variations.
 Skin irritation or dermatitis may occur due to the drug or excipients.
 Most drugs have a high molecular weight and are poorly lipid soluble, so are not
absorbed via skin or mucous membranes.

 Very slow absorption.

 It can be used only for those drugs which need very small plasma concentration for
action.

 Can be used only for drugs which require very small plasma concentration for action.
 Possibility of allergic reactions.
 Drugs of larger particle size not easy to absorb through the skin.

Physiology of human skin

Epidermis

The epidermis is the most superficial layer of the skin and is composed of stratified keratinised
squamous epithelium, which varies in thickness in different parts of the body. It is thickest on the
palms of the hands and soles of the feet. There are no blood vessels or nerve endings in the epidermis,
 but its deeper layers are bathed in interstitial fluid from the dermis, which provides oxygen and
nutrients, and drains away as lymph.

Dermis
The dermis is tough and elastic. It is formed from connective tissue and the matrix contains collagen
fibres interlaced with elastic fibres. Rupture of elastic fibres occurs when the skin is overstretched,
resulting in permanent striae, or stretch marks, that may be found in pregnancy and obesity. Collagen
fibres bind water and give the skin its tensile strength, but as this ability declines with age, wrinkles
develop. Fibroblasts, macrophages and mast cells are the main cells found in the dermis. Underlying
its deepest layer there is areolar tissue and varying amounts of adipose (fat) tissue.
Subcutaneous gland
Subcutaneous gland These consist of secretory epithelial cells derived from the same tissue as the hair
follicles. They secrete an oily substance, sebum, into the hair follicles and are present in the skin of all
parts of the body except the palms of the hands and the soles of the feet. They are most numerous in
the skin of the scalp, face, axillae and groins. In regions of transition from one type of superficial
epithelium to another, such as lips, eyelids, nipple, labia minora and glans penis, there are sebaceous
glands that are independent of hair follicles, secreting sebum directly onto the surface.
 Types of creams

They are divided into two types:-

Oil-in-Water (O/W) creams which are composed of small droplets of oil dispersed in a continuous phase,
and an emulsion in which the oil is dispersed as dropletsthroughout the aqueous phase is
termed an oil-in-water (O/W) emulsion. [Eg.: Vanishing Cream].

Water-in-Oil (W/O) creams which are composed of small droplets of water dispersed in a continuous
oily phase. When water is the dispersed phase and an oil the dispersion medium,the
emulsion is of the water-in-oil. (W/O) type. [Eg.: Cold Cream].

Vanishing creams
They are oil-in-water emulsion. When applied on the surface of the skin, they spread as
thin or less film which is not visible to the naked eye.Hence, they are called as vanshing cream. They
are used to hold powder on the skin as well as to improve adhesion.

Main ingredients and their uses:

Formula %
Stearic acid 24.0
Glycerin 10.5
Potassium Hydroxide 1.0
Purified water 64.0
Perfume 0.5
100.0

 Stearic acid : It governs the consistency to the cream and imparts pearlescent property to the
cream by forming crystals.
Molecular formula : C18H36O2
 Glycerin : It prevents excessive drying of the cream.
Molecular formula : C3H8O3

 Potassium Hydroxide : It imparts fine texture and consistency without providing harsgness.
Molecular formula : KOH

 Purified Water : It provides stability to the cream because hard water leads to the formulation to the
magnesium causing inversion of emulsion.
Molecular formula : H2O

 Perfume : Perfume is a substance that imparts a acent or order, including a sweet and pleasant smell.

Procedure for preparation of vanishing cream

 Stearic acid was melted by heating on water bath.

 Potassium hydroxide was added in water than glycerin was added and mixture was heated at 75℃.
 This mixture was added slowly to the melted stearic acid with constant stirring.
 The obtained mixture was maintainted at 45℃.
 Suitable perfume was added.

Cold cream

These types of emulsions are water-in-oil type of emulsion.They produce cooling sensation by the
evaporations of water, after of cream to emollient action by the layer left on the skin after
application,should be non-occlusive.
Main ingredients and their uses

Working formula %
White bees wax 10.0
Stearic acid 4.0
Mineral oil[Liquid Parffin] 47.0
Borax 4.0
Glycerin 4.0
Preservatives[Methyl Paraben] 1.0
Distilled water 30.0
100.0

White bees wax : It is used as emollient.Commonly referred to as moisturizers, are products thathelp
to soften skin or to treat skin that has become dry. Most emollients are forms of oil or grease, such as
mineral oil, squalene and lanolin. They work by increasing the ability of the skin to hold water,
providing the skin with a layer of oil to prevent water loss and lubricating the skin.

Mineral oil [Liqiud Paraffin] : Mineral oil consists of hydrocarbons derived from petroleum
oil.Mineral oil is clear,odourless and heavily refined oil and it is widely used in cosmetics. Mineraloil
rearely causes allergic reactions and it cannot become solid and clog pores of the skin. It is lightweight
and inexpensive,it helps to reduce water loss from the body and keeps body moisturized.

Stearic acid : Stearic acid is mainly used to support the scent of the product and improve the
texture and spreadability.It governs the consistency to the cream and imparts pearlescent property
to the cream by forming crystals.
Molecular formula : C18H36O2

Borax : It is used to saponifies fatty acids in the beeswax and allows for a more stable cream.
Molecular formula : Na₂B₄O₅₄·₈H
Glycerin : It prevents excessive drying of the cream.
Molecular formula : C3H8O3

Preservatives [Methyl paraben] : It is used to prevent alteration caused by microorganisms. Methyl

paraben is a form of paraben. Parabens are chemicals that are frequently employed as
preservatives to extend the shelf life of items.

Procedure for preparation of cold cream

 Melt all the ingredients by indirect heat in a separate beaker (Part A)

 The emulsifier and oil soluble components (White beeswax oil) was dissolved in the oil phase and
heated to 75℃ (Part B)
 The preservatives and other water soluble components (powdered borax) dissolved in aqueous
phase (part A) and heated indirectly on water bath to 75℃.
 While the still hot add the Part A to the Part B gradually with constant stirring to white beeswax and
oil mixture. Continue this process for the 5 minutes stir all the then remove the heat and stir until it
gets cold.

Characterization/Quality control tests of creams.

 Determination of pH:-
Method: About the 1gm of cream weighed and dissolved in 100ml distilled water and check the pH
of cream with the help of digital meter.

Observation:-

S.No. Creams Test sample value Standard Ph range

1. Vanishing cream 5.3 1 - 6.5
2. Cold cream 6.5 5.6 - 6.8
 Physical appearance:-
Method: The physical appearance of the cream can be observed by its colour, roughness and
graded.
Observation:-

S.No. Properties Vanishing cream Cold cream

1. Colour Pinkish white Dull yellowish white
2. Texture Smooth Smooth
3. Odour pleasant Pleasant

 Homogeneity:-
Method: The formulation was tested for the homogeneity by visual appearance and by touch.
Observation:- Homogeneous in nature and it can be easily applicable on skin.

 Removal:-
Method: The ease of removal of the creams applied was examined by washing the applied part
with tap water.
Observation:- Good with water and better with detergent.

 Dye Test:-
Method: The scarlet red dye mixed cream. Place a drop of cream on a microscopic slide then
covers it with cover slip, and examines it under a microscope. If the disperse globules appear red
the ground colourless. The cream is o/w type. The reverse condition occurs in w/o cream i.e., the
disperse globules appear colourless.
Observation:-

S.No. Creams colour

1. Vanishing cream Red
2. Cold cream Colourless

 After feel:-
Method: Emolliency, slipperiness and amount of residue left after the application of fixed amount
of cream was checked.
Observation: After the application of fixed amount of cream it feels Soft.
 Type of smear:-
Method: After application of cream, the type of film or smear formed on the skin were checked.
Observation: Covers the skin with a protective film to trap in moisture but cannot be observed by
naked eyes.

 Irritancy study:-
Method : Mark an area of 1sq.sm on the left hand dorsal surface. The cream was applied to the
specified area and time was noted. Irritancy was checked, if any, for regular intervals upto 24 hrs
and reported.
Observation : Creams are non-irritant.

Results : Creams were successfully formulated and evaluated.

References :-
 Marri Laxman Reddy Institute of pharmacy “The lab manual of industrial pharmacy” page
no.39-42.
https://mlrip.ac.in/wp-content/uploads/2022/03/INDUSTRIAL-PHARMACY-LAB
MANUAL.pdf
 Chauhan Lalita, Gupta Shalini, Creams: A review on classification, preparation methods,
Evaluation and its applications. Journal of drug delivery and therapeutics 10(5-s),(10.2020).
http://jddtonline.info
 Shashank Yadav, prerana sahu, Prachi Bhimte, Development and characterization of
vanishing cream. Acta Scientific pharmaceutical sciences (6.2023), Volume 7.
 Pal Rahul, Pandey Prachi, Cosmetics and Cosmeceuticals Experiments: Formulation and
Evaluations of Cold Cream(4.2023)
https://www.researchgate.net/publication/369978438_Formulation_and_Evaluations_of_Cold_Cre
am
 Yadav R, Thakur S.K, Parihar R, Chauhan U, Chanana A, Chawra H.S, Pharmaceutical
Preparation and evaluation of cold cream, International Journal of Innovative Science and
Research Technology (5.2023), 8(5).
.https://www.ijisrt.com/assets/upload/files/IJISRT23MAY1437.pdf

 Lachman,Lieberman,H.A. and Kanig, J.L.,The Theory and Practice of Industrial

 Pharmacy,Lea and Febiger, New York, 15th edition, 2013.

 B.S., Kalpesh, K. Mehta, et. All (2016), “Dispensing Pharmacy a Practical Manual”;
page no. 389-399, Pharma Med Press.

 N. Shah, B.M. Methal, (2006), “A Handbook of cosmetics” Vallabh Prakashan, Page no.
162-167.