CRODACOL Series of Fatty Alcohols
 

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CRODACOL C-95 NF (Cetyl Alcohol NF)
CRODACOL C-95 EP (Cetyl Alcohol NF, EP)
CRODACOL S-95 NF (Stearyl Alcohol NF)
CRODACOL S-95 EP (Stearyl Alcohol NF, EP)
CETOSTEARYL ALCOHOL NF (Cetostearyl Alcohol NF)

The CRODACOLS are a range of saturated aliphatic fatty alcohols of non-animal origin. CRODACOLS are wax-like materials that exhibit crystalline properties and are supplied in pastille form. Pastilles are convenient, uniform, free-flowing, non-dusting pellets.

CRODACOLS perform various functions in the pharmaceutical industry; their use is not limited exclusively to topical administration. The National Formulary1 recognizes fatty alcohols as stiffening agents, however they are widely used to emulsify, stabilize and opacify emulsions. Fatty alcohols are crystalline in nature allowing them to be used as structural agents. They confer bodying properties to emulsions, giving them better density and improved viscosity. In doing so, they enhance both the aesthetics and the application properties of the emulsion. As primary emulsifiers their concentration ranges between 5-20%. As stabilizers their concentration ranges between 1-5%. In topical dosages they act as emollients and impart a dry, velvety feel to the skin.

CRODACOLS are also used in anhydrous and low moisture systems such as absorption bases where they aid in the absorption of water. They also aid in the formation of stick products such as lip balms and antiperspirants.

Since CRODACOLS are wax-like substance they maybe used to modify melting characteristics of products including suppository bases. Additionally the waxy nature of fatty alcohols acts as a barrier retarding water penetration, which is useful in the production of controlled release tablets and pellets. Lubricating properties are also attributed to the wax-like nature of the CRODACOL and may provide additional benefits during production or to the final dosage form.

CRODACOLS are also widely used in the personal care industry as conditioning agents in cream type rinses and conditioners. When used in cream rinse conditioners, fatty alcohols deposit on the surface of the hair's cuticle replenishing the lipid content of the hair and providing lubricity. The hair is restored to a more hydrophobic state. This de-wetting and lubrication action on the hair's surface makes wet combing easy and detangling possible.

PRODUCT FEATURES

• Stiffening Agent

• Emulsifier

• Emulsion stabilizer

• Structural agent

• Dry emollience

• Opacifier

• Melt point modifier

• Lubricant

• Wax like material

• Mild to the skin²
   

APPLICATIONS

• Creams

• Ointments

• Tablets

• Suppositories

• Ophthalmics

• Vaginal Delivery

• Antiperspirants

• Aerosol foams

• Controlled Release

PRODUCT RANGE

All three fatty alcohols, Cetyl, Stearyl and Cetostearyl find similar applications in pharmaceutical applications. This is expected since the fatty alcohols are very close in structure. Cetyl and Stearyl alcohol do not occur as pure compounds but have a varying degree of the other alcohol present as the major remaining component. In the case of Cetostearyl Alcohol the material is the eutectic mixture of Cetyl and Stearyl alcohol. Despite these similarities, in most applications, the three products cannot be interchanged without the probability of significantly altering the physical nature of the system involved.

CRODACOL C-95 NF and CRODACOL C-95 EP

Both products, CRODACOL C-95 NF and CRODACOL C-95 EP conform to Cetyl Alcohol NF. CRODACOL C-95 EP additionally conforms to the monograph listed in the European Pharmacopoeia3. Cetyl Alcohol, also know as 1-Hexadecanol is 16 carbons in length with an approximate melting range of 45-52° (please refer to the specification). This melting range is dependent on the minimum Cetyl Alcohol present in the product as dictated by the EP monograph.

CRODACOL C-95 NF is the most commonly used fatty alcohol of the group and is used in a variety of pharmaceutical dosage forms. It emulsifies water-in-oil ointments and improves water-retaining power of absorption bases. In creams or emulsion bases, which are oil in water emulsions, it acts to stabilize and increase the viscosity of the emulsion. Creams using CRODACOL C-95 NF tend to be soft and translucent. Viscosity can be adjusted to suit the route of administration by adjusting the water, CRODACOL and surfactant concentrations.

CRODACOL S-95 NF AND CRODACOL S-95 EP

Both CRODACOL S-95 NF and CRODACOL S-95 EP conform to Stearyl Alcohol NF. CRODACOL S-95 EP additionally conforms to the monograph listed in the European Pharmacopoeia. Stearyl alcohol is 1-Octadecanol and is 18 carbons in length with an approximate melting range of 55-60° (please refer to the specification).

In simple emulsions CRODACOL S-95 NF results in significantly lower viscosity. This is likely due to its different crystalline character and slightly less polar nature. CRODACOL S-95 NF is most frequently used in anhydrous systems and water in oil emulsions where it improves the water absorbing capacity of the formulation. CRODACOL S-95 NF may-be employed in anhydrous sticks to modify texture or to impart structure.

CETOSTEARYL ALCOHOL NF

Fatty alcohol of this type has a synergistic effect when employed with nonionic, anionic and cationic surfactants and produce oil-in-water emulsions of exceptional stability. For this purpose, CETOSTEARYL ALCOHOL NF is frequently used.

FORMULATION EXAMPLES

Three examples of topical semisolid bases are shown to illustrate the use of the CRODACOLS in topical semi-solids.

Hydrophilic Ointment USP¹ (oil-in-water)

REGULATORY STATUS 

• NF Monograph Compliant
   

• PhEur (EP) Monograph Compliant where indicated
   

• 21 CFR 172.864
   

• Inactive Ingredients Search for Approved Drug Products5 lists the following applications: Otic and ophthalmic suspensions, oral enteric capsule, oral tablet, oral film coated tablet, oral sustained action tablet, rectal metered aerosol, topical aerosol, topical cream, topical sustained release cream emulsion, topical lotion, topical ointment and vaginal cream emulsion.
   

COMMERCIAL INFORMATION

CRODACOL pastilles are available in 9 kg HDPE drum, 25 kg polyethylene lined bag, 75 kg polyethylene lined fiber drum. Containers should be stored in dry, cool area away from heat.

Samples may be obtained by contacting our Sample Department at (732) 417-0800, by email at marketing@crodausa.com, through our website www.crodausa.com, or your Croda Sales Representative.

REFERENCES

1. United States Pharmacopoeia, The United States Pharmacopoeia Convention, Rockville, MD

2. Final Report On the Safety Assessment of Cetearyl, Cetyl Alcohol, Isostearyl Alcohol, Myristyl Alcohol and Behenyl Alcohol, J.Am. Coll. Toxicol 1988 7(3) 359-413

3. European Directorate for Quality Medicines –European Pharmacopoeia, Stasbourg, France

4. L.W. Dittert Ed, Sprowls’ American Pharmacy 7th Edition, J.B. Lippincott Company,      Philadelphia, 1974

5. US Food and Drug Administration –Center for Drug Evaluation and Research, Database December 31, 2002.

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