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ISODEL® Vitamin E TPGS (Tocophersolan)

Pharmaceutical -  Nutritional supplement - Food and beverage
Cosmetic - Personal care & Wound care - Veterinary

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:

Emulsifier - solubilizer of poorly soluble drugs - absorption enhancer - PgP inhibitor - plasticizer for HME - stabilizer of Amorphous Solid Dispersion (ASD) - antioxidant

Emulsifier Drug solubilizer Plasticizer for hot melt extrusion Stabilizer of amorphous solid dispersion Absorption enhancer PgP inhibition API for vitamin E deficiency Antioxidant

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

Oral Infusion IV Transdermal Ocular capsule tablet softgel solution

Vitamin E TPGS in drug formulation​ 

​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​​.
 
Track records
 
Formulation using TPGS has been developed for commercial for many drugs in various therapeutic areas like anti-virus (HIV & Hepatisis C), antihyperlipidemic, central nervous sytem deseases (accute treatment of migraine), orphan deases.
 

​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.

PMC Isochem’s offer

PMC Isochem his producing under GMP USP/NF compliant ISODEL® Vitamin E TPGS for 10 years. PMC Isochem owns a DMF Type II for the acive ingredient application.

PMC Isochem offers a robust supply of ISODEL™ Vitamin E TPGS with manufacturing capacity over two GMP FDA Audited plants.

Packaging proposed are 1, 5, 20 and 100 kg.

Technical and quality support​
 
Technical support for storage and handling; Information for quality and pharmaceutical regulatory​ available on demand.
 
Research products​
 
PMC Isochem offers ISODEL™  TPGS analogues with Polyethylene glycol chain molecular weight of 200, 300, 400, 1500, 2000 and 4000 g/mol.
Standard TPGS has a Polyethylene glycol molecular weight of 1000 g/mol. 
 

For more detailed technical support, please contact us

Publication: Using Tocophersolan for Drug Delivery, Pharmaceutical Technology - January 2015