Vitamin E TPGS

 

 

Vitamin E TPGS, a water soluble derivative of natural Vitamin E, is a multirole excipient for pharmaceutical drug delivery innovation. Vitamin E TPGS is a non-ionic surfactant used as:

  • solubilizer of poorly soluble drugs
  • absorption enhancer
  • emulsifier
  • vehicle for lipid-based drug formulation
  • antioxidant

Vitamin E TPGS is also used as an efficient source of natural Vitamin E both for therapeutic and nutrition purposes.​

​Regulatory 

A National Formulary (NF) monograph is in the United States Pharmacopeia / National Formulary (USP/NF) version USP 40 – NF 35. Several commercial drugs using Vitamin E TPGS are approved by FDA and EMEA, PMDA.

Vitamin E TPGS in drug formulation​ 

Formulation fields: 
Vitamin E TPGS has been used mainly in oral dosage forms for years but new delivery applications are being investigated in parenteral, nasal, ophthalmic, dermal deliveries​​
 
Benefits:​
- Enhancement of Bioavailability by increasing solubility of poorly water-soluble APIs and by formulation of Self Emulsifying Drug Delivery System (SEEDS)​
- Thermal stability for hot melt extrusion as a versatile plasticizer with solubilizer properties and as Antioxidant for sensitive excipients​​​
 
Track records:​
Formulation using TPGS has been developed for commercial drugs : ​
  • Two anti HIV drugs, AGENERASE® (Amprenavir) soft gel capsules and oral solution and APTIVUS® (Tripanavir) oral solution ​

  • One anti HCV drug, VIEKERA Pack™ (combination of 3 APIs) tablets​

PMC Isochem’s offer

PMC Isochem his producing, under GMP, ISODEL® Vitamin E TPGS for 10 years. PMC Isochem owns a DMF Type II 

Large quantity
 
PMC Isochem offers large production capacity for both NF grade according to USP/NF monography and API grade according to US Type II drug master file  (DMF number : 23823). PMC Isochem offers a robust supply of ISODEL®  Vitamin E TPGS with manufacturing capacity on two different GMP FDA Audited.
Large quantities are supplied upon order and samples for development and qualification are available upon request.​​​
 
Research products​
PMC Isochem offers ISODEL®  TPGS analogues with Polyethylene glycol chain molecular weight of 200, 300, 400, 1500, 2000 and 4000g/mol. Standard TPGS has a Polyethylene glycol molecular weight of 1000g/mol.  
 
Technical and Quality support​
PMC Isochem offers to its clients :​
  • technical support for storage and handling​

  • information for quality and pharmaceutical regulatory​

 

For more detailed technical support, please contact us

Reference:  Yves Robin, Pharmaceutical Technology - January 2015

Download TPGS brochure