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
stabilizer of Amorphous Solid Dispersion (ASD)
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 :