Excipients for Drug Formulation

Kolliwax® S Fine

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.

Why choose Kolliwax® S Fine?

  • Fully approved, pharmaceutical-grade excipient – for your peace of mind
  • Compatible to a large number of actives
  • Guaranteed performance across a wide variety of applications
  • Particularly suitable for sensitive APIs
  • Effective alternative to magnesium stearate as lubricant
  • No metallic taste development

Major Applications of Kolliwax® S Fine

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.

Kolliwax® S Fine can also be used as moisture protective component for coating films together with hydroxypropoylmethylcellulose (HPMC) and microcrystalline cellulose (MCC).

In combination with Kollicoat® SR 30 D, Kolliwax® S Fine creates sustained release profiles.

Suppository formulations containing high amount of glycerol can be hardened by the addition of Kolliwax® S Fine.

Kolliwax® S Fine can be used as a consistency factor and co-emulsifier in topical pharmaceutical applications. The typical concentration in emulsions and creams is about 1-5%. As a structure-building consistency factor with dry feel it forms a crystalline barrier on skin.

For softgel formulations Kolliwax® S Fine can be used as emulsifying, viscosity enhancer and solubilizing agent or as solid lubricant for capsules shells.

Product Details
Chemical name Stearic acid + palmitic acid
Former product name Speziol® L2SM GF Pharma
CAS No 67701-03-5
Raw material origin Kolliwax® S Fine is based on vegetable and synthetic raw materials.
Regulatory status

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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