Drug delivery innovation: Vitamin E TPGS and Polyamino acids

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

Amino acid based biopolymer diversity for innovative therapies

Why a polyaminoacid based delivery technology?

Growing interest for advanced biomedecines
Biocompatibility and biodegradability
Chemical & Architectural Versatility of Polyamino acids
Many therapeutic areas: Immunotherapy, Oncology, Gene Therapy, Inflammatory, Neurodegenerative, Infectious, Diagnosis, Skin care…

Which delivery technology?

A biomaterial toolbox for various Nanotechnologies and Drug Conjugates