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Wax, anionic emulsifying
موم امولسیفایر آنیونی
1Nonproprietary names
- BPEmulsifying Wax
- Ph. Eur.Cetostearyl Alcohol (Type A), Emulsifying
- Ph. Eur.Cetostearyl Alcohol (Type B), Emulsifying
2Synonyms and trade names
Anionic emulsifying wax; emulsifying wax BP; emulsifying cetostearyl alcohol; Lanette Wax SX; Lanette N
3Chemical name and CAS Registry Number
Mixture of cetostearyl alcohol and an anionic surfactant (sodium lauryl sulfate or sodium cetostearyl sulfate) · [—]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Surfactant, emulsifier, Semi-solid base, emollient
Typical concentrations: — · Dosage forms: Semi-solid
6Applications in pharmaceutical formulation
Used as an emulsifying agent and stiffener to make o/w creams and emulsifying ointments. Classic examples are Emulsifying Ointment BP (30% emulsifying wax with white soft paraffin and liquid paraffin) and Aqueous Cream BP, which contains 30% emulsifying ointment.
7Description
A white or pale yellow waxy solid or flakes with a faint characteristic odour. It becomes plastic when warm and melts to a clear liquid. On mixing with water when melted it forms stable o/w emulsions.
8Typical properties
- Composition (BP)
- cetostearyl alcohol 9 parts and sodium lauryl sulfate 1 part, with a small amount of water
- Melting range
- about 50–56 °C
- Solubility
- soluble in ether and chloroform, partly soluble in ethanol (95%); practically insoluble in water but forms emulsions when melted with water
- Ionic character
- anionic
- Physical form
- white or pale yellow waxy solid or flakes
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place. Creams made from it need an antimicrobial preservative.
10Incompatibilities
Because of its anionic surfactant it is incompatible with cationic compounds, such as quaternary ammonium antiseptics and many basic drugs, and with polyvalent metal ions; high electrolyte concentrations and strongly acidic conditions may destabilise emulsions.
11Method of manufacture
Made by melting cetostearyl alcohol, adding sodium lauryl sulfate (or sodium cetostearyl sulfate) and a little water, heating with stirring until the water is removed and a homogeneous mass is obtained, and then cooling and flaking.
12Safety
Used widely in topical products and generally regarded as non-toxic. The sodium lauryl sulfate component can irritate the skin; Aqueous Cream BP used as a leave-on emollient has been associated with stinging and skin irritation, particularly in children with eczema, and is better used as a soap substitute.
13Handling precautions
Observe normal precautions for the quantity handled. Take care with the hot molten wax; eye protection and gloves are recommended.
14Regulatory status
Included in non-parenteral (topical) medicines licensed in the UK and Europe.
15Related substances
Cetostearyl alcohol; sodium lauryl sulfate; wax, nonionic emulsifying; cetrimide emulsifying wax (cationic).
16Comments
Choose the emulsifying wax according to the charge of the drug: anionic wax for neutral or anionic drugs, nonionic (cetomacrogol) wax where electrolytes or a wide pH range are involved, and cationic wax with cationic drugs. Ph. Eur. describes two emulsifying cetostearyl alcohols: Type A contains sodium cetostearyl sulfate and Type B sodium lauryl sulfate.