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Cold cream

Cold Cream: History, Formula, Method, Uses, Evaluation

Cold cream is a water in oil (W/O) emulsion, in the European Pharmacopoeia cold cream is known as Fatty Cream. Before the 1st century, many druggists would compound the rosewater cream and keep it fresh on ice, to make it cold as a skin cream. Cold cream was originally described as the Latin word “refrigeran” meaning “making cold” because when applied, the water evaporates and creates a cooling sensation [1]. You may also read: Difference between Ointment, Cream, Paste, Gel, Lotion, and jelly. 

What Is Cold Cream

Cold cream is a water in oil (W/O) emulsion, in the European Pharmacopoeia cold cream is known as Fatty Cream. In cold cream, the major portion is the oil phase. Simply, the cold cream is an oil-based semisolid preparation. Cold cream is also known as Unguentum or Ceratum Refrigerans [2]. Generally, it contains mineral oil, beeswax, borax, and water [1]. It is a soothing and cleansing cosmetic typically of oily and heavy consistency, used to soothe and cleanse the skin. It can be classified as a form of cleansing cream. Cream vs Ointment 

Cold cream is an emulsion in which the proportion of fatty and oily material predominates, although when it is applied to the skin a cooling effect is produced due to slow evaporation of the water contained in the emulsion [3]. Cold cream is an example of a Water-in-oil (W/O) emulsion

According to European Pharmacopoeia, cold cream is known as Fatty Cream.

Cold cream

Why cold cream is called cold cream?

The name “cold cream” derives from the cooling feeling of the cream, when applied the water evaporates and creates a cooling sensation. Besides, in cold cream, the major portion is the oil phase thus cold cream is used especially in cold temperature or winter season. On the other hand, vanishing cream is used for summer or hot environments because vanishing cream contains a large portion of the aqueous phase.

Ideal characteristics of cold cream

  1. It should not normally be diluted.
  2. The pH of the cold cream must be optimum from 4.6–6.0
  3. Its consistency should be optimum so that it can be easily put out from the container and apply easily.
  4. Should give a cooling effect on the skin after external application.
  5. It must provide a thin waxy protective layer on the skin to protect the water evaporation from the skin surface.
  6. Should give a faster emollient effect, so that very dry skin can swell up and become soft within a short time.
  7. Less greasy than ointment.
  8. Generally, creams are white to off-white color but may have different colors such as yellow (Nystatin Cream USP).
  9. Easily spread on the skin.
  10. Free from gritty particles.
  11. It should be nontoxic and nonirritant.
  12. Attractive in appearance.
  13. It should be physically and chemically stable throughout its shelf-life.
  14. The excipients should be compatible with each other.
  15. It should be more easily washed off using water.
  16. Should be sterile.

History of Cold Cream preparation

Cold cream was first invented by Galen, a famous Greek physician- pharmacist in the Roman Empire (who practiced in Rome) of the 1st Century AD. The Galen formula of cold cream has changed but little in proportions or method of preparation throughout many centuries [1].

Raw materials and Apparatus to prepare Cold Cream

Raw materials as per formula. Cold creams may be formulated by oils, both or either mineral oil and vegetable oil, as well as fatty alcohols, fatty acids, and fatty esters, emulsifying agents, preservatives, and purified water. There should four main ingredients as follow:

Apparatus required laboratory-scale production as following:

  • Measuring Cylinder,
  • Beaker,
  • Stirrer/ Glass rod,
  • Thermometer,
  • Water bath.

Galen’s Cerate (Cold Cream) Formula for 1000 g [2]

Name of Raw materials Quantity Function
Cetyl Esters Wax 125.00 g Stiffening agent and Emollient
White Wax/ White Beeswax 120.00 g Stiffening agent
Almond Oil 560.00 g Emollient
Sodium Borate USP-NF/Borax BP 5.00 g Emulsifying agent
Stronger Rose Water 25.00 ml Flavoring agent
Rose Oil 0.20 ml Flavoring agent
Purified Water q.s. to 1000.00 g Vehicle and Solvent

Method of preparation

General preparation method is, prepare an oil and aqueous phase separately and then mix, after mixing add fragrance or other ingredients, then homogenize and congeal.

Preparation of oil phase: Melt together Cetyl esters wax, almond oil, and white wax in a beaker with continuous heating at 70°C-80°C.

Preparation of aqueous phase: Dissolve the sodium borate in the purified water and stronger rose water warmth to 70°-80°C. Then slowly add the warm aqueous phase to the oil phase, with continuous stirring until it has cooled to about 45°C. Then add the rose oil, finally, homogenize for 30 minutes and congeal this cream.Cold cream in Beaker

BP Formula of Cold Cream [4]

As a pharmaceutical preparation, cold cream was included in the issue of The British Pharmaceutical Codex in 1949, as an ointment of rose water.

Name of Raw materials Quantity Function
Almond oil 610.00 ml Emollient,  Solvent and vehicles of an oil phase
White beeswax 180.00 g Stiffening agent
Borax 10.00 g Emulsifying agent
Rosewater 199.00 ml Vehicle and Solvent of an aqueous phase
Oil of rose 1.00 ml Flavoring agent

Procedure: Melt the beeswax and almond oil at 75-80°C together. Melt borax dissolved in the rose water at 75-80°C. Mix the two-phase with constant stirring. Then add the rose oil, homogenize and congeal until cold.

USP Formula of Cold Cream for 1000.00 g [5]

Name of Raw materials Quantity Function
Spermaceti/ Cetyl Esters Wax 125.00 g Stiffening agent and Emollient
White wax 120.00 g Stiffening agent
Mineral oil 560.00 g Emollient,  Solvent and vehicles of an oil phase
Sodium borate 5.00 g Emulsifying agent
Purified water 190 ml Vehicle and Solvent of an aqueous phase

Method of preparation

Preparation of oil phase: Melt together white wax and cetyl esters wax in a glass or SS beaker, add the almond oil and continue heating at 70°-80°C.

Preparation of Aqueous phase: Add the sodium borate in the purified water heat to 70°-80°C until dissolve.

Then slowly add the aqueous phase to the oil phase, stirring continuously until it has cooled to about 45°C. Then homogenize and congeal.

Formula of Beeswax-Borax type Traditional Cold Cream

Name of Raw materials Quantity Function
Mineral oil 450.00 ml Emollient,  Solvent and vehicles of an oil phase
Beeswax 160.00 g Stiffening agent
Borax 10.00 g Emulsifying agent
Methyl parahydroxybenzoate 1.20 g Antimicrobial preservative
Propyl parahydroxybenzoate 0.20 g Antimicrobial preservative
Perfume 3.00 g Flavoring agent
Purified water 375.60 ml Vehicle and Solvent of an aqueous phase

Method of preparation

Heat together the mineral oil and beeswax to a temperature of 75-80°C in a beaker. Dissolve the borax, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate in the water and heat to 75°C in another beaker, and add slowly with continuous stirring to the oil/wax phase. Cool to about 45°C with stirring add the perfume.

Standard Formula

Name of Raw materials Quantity Function
White Wax/ White Beeswax 20.00-24.50 g Stiffening agent
Mineral oil (Liquid paraffin) 50.00-56.00 ml Emollient,  Solvent and vehicles of an oil phase
Sodium Borate USP-NF/Borax BP 0.50-0.70 g Emulsifying agent
Glycerin USP/ Glycerol BP 4.28 ml Humectant
Methylparaben 0.20 g Antimicrobial preservative
Propylparaben 0.02 g Antimicrobial preservative
Fragrance (IFF-5448616-scalp Klin-046) 0.50 ml Flavoring agent
Tween-80/ Polysorbate 80 0.50 ml Emulsifying agent
Purified water q.s. to 100.00 ml Vehicle and Solvent of an aqueous phase

Method of preparation of cold cream

  • Preparation of oil phase: White Wax/ White Beeswax and Mineral oil (Liquid paraffin) were melted in a glass or SS beaker at 70°-80°C and mixed.
  • Preparation of aqueous phase: Methylparaben, propylparaben, tween-80, borax, and glycerin were dissolved in water in another beaker at the temperature 70°-80°C.
  • Addition of aqueous phase to oil phase: The oil phase was then added to the aqueous phase with continuous stirring until it has cooled to about 45°C. Then fragrance was added with continuous stirring.
  • Homogenization of the cream by a homogenizer and congealing.
  • Filling, labeling, and packaging.

Formula of Typical Modern Cold Cream [3]

Name of Raw materials Quantity Function
Mineral oil 400.00 ml Emollient,  Solvent and vehicles of an oil phase
Beeswax 160.00 g Stiffening agent
Isopropyl Myristate 50.00 g Thixotropic properties enhancer and Emollient
Petroleum jelly 50.00 g Emollient
Borax 10.00 g Emulsifying agent
Perfume 3.00 ml Flavoring agent
Methyl parahydroxybenzoate 1.00 g Antimicrobial preservative
Propyl parahydroxybenzoate 0.20 g Antimicrobial preservative
Purified Water 325.80 ml Solvent and vehicles of an aqueous phase

Method of preparation

Heat together the mineral oil, Isopropyl Myristate, Petroleum jelly, and beeswax to a temperature of 75-80°C in a glass or SS beaker. Dissolve the borax, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate in the purified water and heat to 75°-80°C, and add slowly with continuous stirring to the oil/wax phase. Cool with stirring to about 35°C and add the perfume.

Uses of cold cream

  1. Medicated cold cream is mainly used for the treatment of skin.
  2. To help in the maintenance of moisture balance of skin and avoid rough skin conditions.
  3. As cleansing preparation to remove make-up
  4. To provide an emollient effect.
  5. To provide an oily protective layer on the skin.
  6. In medicated cream as a carrier for drug substances such as diflucortolone valerate.
  7. To remove oil-soluble impurities.
  8. As shaving cream

Cold cream example/ Market preparations

Pond’s Cold Cream, Nivea clod Cream, Avene cold cream, Eve Lom Cleansing Balm, Noxzema Classic Clean Deep Cleansing cream, Avène, Prai Beauty Platinum Cold Cream Cleanser, Queen Helene Triple Whipped Professional Cleansing Cream, Merle Norman Cleansing Cream, Cocoa Butter Garnier, Mustela cold cream, Johnson & Johnson’s baby cream, Clarins Gentle Day Cream, Diflucortolone cold Cream.

Sterility, storage and labeling information

It should be sterile, it complies with the test for sterility.

Storage

It should not be permitted to freeze.

Labeling information

The label information should contain:

  • Manufacture and expiration date
  • Conditions under which the it should be stored,
  • Where applicable,
  • Name of any added antimicrobial preservative.

To clear your concept you should know first about cream and its types. You may read the additional information below. 

Definition of Cream

Creams are opaque, viscous, relatively soft, consistently spreadable, a semisolid dosage form that often comprises more than 20% water & volatiles and normally less than 50% hydrocarbons, waxes, or polyols as the vehicle for the drug substance, intended for external application [4]. Actually, creams are semisolid emulsion dosage forms. Most of the pharmaceutical cream is oil in water or vanishing cream type.

Types of Cream

According to emulsion type

Lipophilic creams/ Cold cream is a water in oil (W/O) emulsion, in the European Pharmacopoeia it is also known as Fatty Cream. In lipophilic cream, the main ingredient is oil.  When the aqueous phase is dispersed in an oil phase, the emulsion is referred to as a water-in-oil (W/O) emulsion, and oil is referred to as the continuous phase.

Hydrophilic cream/ Aqueous Cream / Vanishing cream is an example of an Oil-in-water (O/W) emulsion. When an oil phase is dispersed in an aqueous phase, the emulsion is termed an oil-in-water (O/W) emulsion, and water is referred to as the continuous phase [6].

According to function

Cleansing cream, Moisturizing cream, Message Creams, medicinal cream, emollient creams, shaving creams, hand creams, and foundation creams. If you have any comments please feel free a drop your comments. You may also read: Quality control tests of tablets

Evaluation of cold cream preparation

The following several tests may perform to evaluate the quality of a cold cream:

  1. Appearance/ Description
  2. Viscosity test
  3. Uniformity of Dosage Unit (if required)
  4. Impurities
  5. Microbiological Examination
  6. Water content determination
  7. Assay (if required))

References

  1. Susan C. Wivell, Clear cold cream cosmetic compositions, United States Patent. 1996. https://patents.google.com/patent/US5525344A/en
  2. Remington, Joseph P, and Paul Beringer. Remington: The Science and Practice of Pharmacy. 21st edition. Philadelphia: Lippincott Williams & Wilkins; 2005.
  3. Poucher, W A, and George M. Howard. Perfumes, Cosmetics, and Soaps. London: Chapman and Hall, 1974.
  4. British Pharmacopoeia Commission. British Pharmacopoeia 2021. London: TSO.
  5. The United States pharmacopeia The National formulary. Rockville, Md.: United States Pharmacopeial Convention, Inc. (USP 21 – NF 16).
  6. Lachman, Lieberman, H.A. and Kanig, J.L., The Theory and Practice of Industrial Pharmacy, Lea and Febiger, New York, 15th edition; 2013.

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