STABILITY AND STORAGE CONDITIONS
SHREE CHEM-CO-35 forms stable solutions in many organic solvents such as chloroform, ethanol and propan-2-ol; it also forms clear, stable, aqueous solutions. SHREE CHEM-CO-35 is miscible with other polyoxyethylene castor oil derivatives and on heating with fatty acids, fatty alcohols and some animal and vegetable oils. Solutions of SHREE CHEM-CO-40 in
aqueous alcohols are also stable.
On heating an aqueous solution the solubility of SHREE CHEM-CO-35 is reduced and the solution becomes turbid. Aqueous solutions of polyoxyl castor oil heated for prolonged periods may separate into solid and liquid phases on cooling. However, the product can be restored to its original form by homogenization.
Aqueous solutions of SHREE CHEM-CO-35 are stable in the presence of low concentrations of electrolytes such as acids or salts, with the exception of mercuric chloride.
Aqueous solutions of SHREE CHEM-CO-35 can be sterilized by autoclaving for 20 minutes at 121 oC. In this process a product may acquire a deeper color although this has no significance for product stability. Aqueous solutions of polyoxyl castor oil can similarly be sterilized by autoclaving at 121 oC, but this may cause a slight decrease in the pH value.
Polyoxyethylene castor oil derivatives should be stored in a well-filled, airtight container, protected from light, in a cool, dry, place.
Polyoxyethylene castor oil derivatives are used in a variety of oral, topical and parenteral pharmaceutical formulations.
Acute and chronic toxicity tests in animals have shown polyoxyethylene castor oil derivatives to be essentially nontoxic and nonirritant materials. However, several serious anaphylactic reactions have been observed in humans and animals following parenteral, and more rarely, oral administration of formulations containing polyoxyethylene castor oil derivatives.
Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended.
Applications in Pharmaceutical Formulation or Technology
Polyoxyethylene castor oil derivatives are nonionic surfactants used in oral, topical and parenteral pharmaceutical formulations. They are also used in cosmetics animal feeds and Textile.
SHREE CHEM-CO-35 is mainly used as an emulsifing and solubilizing agent, and is particularly suitable for the production of aqueous liquid preparations containing volatile oils, fat-soluble vitamins and other hydrophobic substances.
SHREE CHEM-CO-35 has also been used as a solvent in proprietary injections of diazepam, propanidid and alfaxalone with alfadolone acetate. SHREE CHEM-CO-35 is also used in the production of glycerin suppositories.
In veterinary practice, SHREE CHEM-CO-35 can be used to emulsify cod liver oil, and oils and fats incorporated into animal feeding stuffs.
In cosmetics, SHREE CHEM-CO-35 is mainly used as a solubilizing agent for perfume bases and volatile oils in vehicles containing 30-50% v/v alcohol (ethanol or propan-2-ol). In hand lotions it can be used to replace castor oil.
SHREE CHEM-CO-40 may be used in preference to SHREE CHEM-CO-35 in oral formulations since it is almost tasteless. In aqueous alcoholic or completely aqueous solutions, SHREE CHEM-CO-40 can be used to solubilize vitamins, essential oils and certain drugs. Other materials which can be solubilized are, alfadolone, alfaxalone, hexacholrophane, hexetidine, methotrimeprazine, miconazole, propanidid, and thiopentone.
In aerosol vehicles which include water, the addition of SHREE CHEM-CO-40 improves the solubility of the propellant in the aqueous phase. This enhancement applies both to dichlorodifluoromethane and to propane/butane mixtures.
Foam formation in aqueous ethanol solutions containing SHREE CHEM-CO-40 can be suppressed by the addition of small amounts of polypropylene glycol 2000.
SHREE CHEM-CO-40 is also used as an emulsifier of fatty acids and alcohols.
Emulsifier, Co-emulsifier, Dispersant, Solubilizer, Lubricant, Anti stant, Emclient Wetting agent, Scouring agent, Deformer,
Softener, Lubricant, Viscosity control Agent, Dying Assistant Dye Carrier, Levelling agent, Stabilizer, Penetrant.