Cetyl Alcohol

Cetyl Alcohol is known as a Coating agent, emulsifying agent, stiffening agent. Cetyl Alcohol is one of the ingredients in Arvin Kala’s diverse product portfolio.

Description

Cetyl alcohol appears in the form of waxy, white flakes, granules, cubes, or castings. It possesses a faint characteristic odor and a bland taste. The structural form of Cetyl alcohol is as follows:

Applications in Pharmaceutical Formulation

Cetyl alcohol is extensively utilized in cosmetics and pharmaceutical products, including suppositories, modified-release solid dosage forms, emulsions, lotions, creams, and ointments.

In suppositories, cetyl alcohol is utilized to increase the melting point of the base. In modified-release dosage forms, it can be used to create a permeable barrier coating. In lotions, creams, and ointments, cetyl alcohol is valued for its emollient, water-absorptive, and emulsifying properties. It enhances stability, improves texture, and increases consistency. The emollient properties stem from the absorption and retention of cetyl alcohol in the epidermis, where it lubricates and softens the skin, giving it a characteristic ‘velvety’ texture.

Cetyl alcohol is also utilized for its water absorption properties in water-in-oil emulsions. For instance, a mixture of petrolatum and cetyl alcohol (19:1) can absorb 40-50% of its weight in water. Cetyl alcohol functions as a mild emulsifier for water-in-oil emulsions, which allows for a reduction in the amount of other emulsifying agents needed in a formulation. Additionally, cetyl alcohol has been noted to enhance the consistency of water-in-oil emulsions.

In oil-in-water emulsions, cetyl alcohol is known to enhance stability by interacting with the water-soluble emulsifying agent. This combination creates a tightly packed, monomolecular barrier at the oil-water interface, which acts as a mechanical barrier to prevent droplet coalescence.

In semisolid emulsions, excess cetyl alcohol interacts with the aqueous emulsifier solution to create a viscoelastic continuous phase. This phase imparts semisolid properties to the emulsion and prevents droplet coalescence. Consequently, cetyl alcohol is often called a ‘consistency improver’ or ‘bodying agent.’ However, it may be necessary to combine cetyl alcohol with a hydrophilic emulsifier to achieve this effect.

It is important to note that pure or pharmacopeial grades of cetyl alcohol may not form stable semisolid emulsions and may lack the same physical properties as grades of cetyl alcohol that contain significant amounts of other similar alcohols.

Stability and Storage Conditions

Cetyl alcohol remains stable when exposed to acids, alkalis, light, and air; it does not become rancid. It should be stored in a well-closed container in a cool, dry place.

Method of Manufacture

Cetyl alcohol can be produced through various methods, including the esterification and hydrogenolysis of fatty acids or the catalytic hydrogenation of triglycerides derived from coconut oil or tallow. It can be purified by crystallization and distillation.

Safety

Cetyl alcohol is primarily used in topical formulations, but it has also been utilized in oral and rectal preparations.

Cetyl alcohol has been linked to allergic delayed-type hypersensitivity reactions in patients with stasis dermatitis. Cross-sensitization with cetostearyl alcohol, lanolin, and stearyl alcohol has also been reported. It is suggested that hypersensitivity may be due to impurities in commercial grades of cetyl alcohol, as highly refined cetyl alcohol (99.5%) has not been associated with hypersensitivity reactions.

LD50 (mouse, IP): 1.6 g/kg

LD50 (mouse, oral): 3.2 g/kg

LD50 (rat, IP): 1.6 g/kg

LD50 (rat, oral): 5 g/kg

Handling Precautions

Take standard precautions suitable for the situation and the amount of material being handled. It is recommended to use eye protection and gloves.

Chemical-physical values

Test Item Unit Specification
ACID VALUE
mg KOH/g
Max 0.5
COLOUR
APHA
Max 40
FATTY ALCOHOL
%
Min 95.0 & Max 110.0
HYDROXYL VALUE
mg KOH/g
Min 225 & Max 235
IODINE VALUE (HANUS)
gI2/100g
Max 2.0
MELTING POINT
°C
Min 46 & Max 51
SAPONIFICATION VALUE
mg KOH/g
Max 1.0
WATER CONTENT
%
Max 0.5

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