Kolliwax® HCO is hydrogenated castor powder for pharmaceutical application used as consistency factor in topical formulations, as lipohphillic lubricant in tablets and capsules and as plasticizer in solid dispersions using spray drying, melt granulation or hot melt extrusion processes. Kolliwax® HCO is particularily suitable for formulation ofsensitive APIs.
Hydrogenated castor oil (Kolliwax® HCO) is a hard wax with a high melting point used in oral and topical pharmaceutical formulations and is used as a lubricant for tablets and capsules. Furthermore HCO can be used to prepare a sustained release formulation for water soluble APIs (e.g. Alfuzosin-HCL, Aminophyllin, Lithiumcarbonat, Niacin, Sulfanilamid, Theophylline). It can either as lipophilic matrix former or as a coating ingredient. Kolliwax® HCO can be used as a standalone solution as well as in combination with other sustained release polymers. Kolliwax® HCO was formerly known as Cutina® HR PH.
In topical formulations, Kolliwax® HCO can be used as consistency factor to enhance the viscosity of the formulation. The typical concentration at about 0.1-2% hydrogenated castor oil is compatible with most natural vegetable and animal waxes and can therefore be used in combination with fatty alcohols and other consistency factors.
Similar to emollients, waxes affect the sensory profile and the stability of a topical formulation. They are solid at ambient temperatures and stabilize emulsions as the viscosity is increased by formation of lamellar structures in oil-in-water formulations. Furthermore Kolliwax® HCO has a special advantage because of its high melting point and is able to support the formulation stability particularly at elevated temperatures.
Lubricant in tablet and capsule formulations
Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine. Lubricants also ensure that tablet formulations and ejection can occur with low friction. Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid, are most frequently used lubricants in tablets or hard gelatin capsules. Lubricants are added in small quantities to table or capsule formulations to improve certain processing characteristics.
In tablet formulations Kolliwax® HCO can be used as a lubricant as an effective alternative to magnesium stearate. Hydrogenated castor oil is compatible to a large number of actives and does not provide a metallic taste. Kolliwax® HCO is particularly suitable for formulation of sensitive APIs.
Plasticizer in solid dispersions
In solid dispersions, Kolliwax® HCO is used as plasticizer in solid polymeric matrices. It is suitable for melt granulation, spray drying and hot melt extrusion processes.
Ph. Eur.: Castor Oil Hydrogenated, USP/NF: Hydrogenated Castor Oil, JP: Hydrogenated Oil