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Sodium Stearyl Fumarate Lubricant

Tanlube

Tanlube (Sodium Stearyl Fumarate) is a next-generation, less hydrophobic specialised lubricant with excellent lubrication potential that does not hamper dissolution profile, hardness or other functional attributes.

Its lubrication is largely independent of processing parameters such as blending time and lubricant concentration. It can also be used effectively in melt-in-mouth tablets, effervescent formulations and drugs incompatible with metals.

Applications
Melt-in-mouth tablets, effervescent formulations, metal-incompatible actives

Tanlube

01

Specification

ParameterLimit
WaterNMT 5.0%
LeadNMT 0.001%
Heavy metalsNMT 0.002%
Saponification value142.2 to 146.0 (anhydrous basis)
Sodium stearyl maleateNMT 0.25%
Stearyl alcoholNMT 0.5%
AssayNLT 99.0% and NMT 101.5% w/w (dried basis)
StoragePreserve in well-closed containers
Shelf lifeFive years from manufacturing month

02

Application

  • Inert, hydrophilic super lubricant for tablets, granules, spansules and capsules
  • Water-soluble lubricant for solid oral dosage forms
  • Especially effective in orally disintegrating tablets
  • Effective usage level: 0.25 – 3.0% w/w

03

Advantages

  • Lower insoluble residue on dissolution or effervescence
  • Higher tablet hardness and lower ejection forces
  • Less impact on disintegration times; less sensitive to blending time
  • Anti-adherent properties, a high melting point and a controlled particle size
  • Better mouthfeel than conventional metallic stearates, suiting melt-in-mouth and effervescent tablets
  • Avoids active incompatibility, over-lubrication and film formation in effervescent tablets
  • Useful where other lubricants fail to give adequate stability, hardness, content uniformity, disintegration and dissolution rate
  • Improves disintegration and friability characteristics of tablets

04

Tanlube vs. magnesium stearate

  • Less retardant effect on dissolution rate than magnesium stearate, even after extended mixing or blending
  • Effect of blend time on disintegration compared at 2% Tanlube and 2% magnesium stearate