Used for various oral solid as well as semi-solid dosage forms: It can be used as a lubricant in oral dosage forms, matrix forming agent in sustained-release dosage forms, emulsifying and solubilizing agent in topical formulations and hardening agent in glycerin suppositories. Kolliwax® S Fine is particularly suitable for sensitive APIs.
Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine. Lubricants also ensure that tablet formulation and ejection can occur with low friction. Common minerals like silica or talk, and fats, i.e. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. Lubricants are added in small quantities to tablet and capsule formulations to improve certain processing characteristics.
In tablet formulations, Kolliwax® S Fine can be used as a lubricant as an effective alternative to magnesium stearate. Stearic acid is compatible to a large number of actives and does not provide a metallic taste. When used as lubricant Kolliwax® S Fine is blended to granular phase. The selection of the grade depends on formulation properties.
For film coating applications, Kolliwax® S Fine can be dispersed into hot (~60 C) aqueous solutions of hydroxypropoylmethylcellulose (HPMC). MCC can be added to further reduce water vapor transmission rate of the film. As a matrix former in sustained release tablets the use of 8-20% of Kolliwax® S Fine is recommended.
|Chemical name||Stearic acid + palmitic acid|
|Former product name||Speziol® L2SM GF Pharma|
|Raw material origin||Kolliwax® S Fine is based on vegetable and synthetic raw materials.|
Ph. Eur, USP/NF: Stearic Acid 50
JP: Stearic Acid
A kosher certificate for Kolliwax® S Fine is available upon request. All Kolliwax® grades are produced under IPEC GMP guidelines.
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