Technical characteristics

Vitamin E TPGS

Chemical Name: D-α tocopheryl polyethylene glycol 1000 succinate

Other Names: Tocofersolan, Tocophersolan, TPGS, Vitamin E TPGS

 

CAS: 9002-96-4

US DMF: type IV

VITAMIN E TPGS comes from the esterification of Vitamin E succinate with PEG 1000.


APPLICATION FIELD OF VITAMIN E TPGS

Due to its properties, Vitamin E TPGS is used for various applications:

  • Pharmaceutical
  • Nutraceutical
  • Food & Beverage
  • Cosmetic & Personal Care
  • Animal Nutrition

Marketed Products
A large number of formulations 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, and approved by different agencies like FDA and EMEA, PMDA.

PROPERTIES OF VITAMIN E TPGS

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

Improving Bioavailability

  • Absorption enhancer
  • PgP inhibitor

Surfactant properties

  • Drug solubilizer
  • Emulsifier
  • Vehicule for lipid based formulation (SEDDS* and SMEDDS*)
  • Plasticizer for hot Melt Extrusion
  • Stabilizer for amorphous solid dispersion

Source of Vitamin E

  • API for Vitamin E (water soluble source of Vitamin E)
  • Antioxidant

* SEDDS: Self-Emulsifying Drug Delivery System
** SMEDDS: Self-MicroEmulsifying Drug Delivery System

type of formulation and administration pathway

Formulation

  • Tablet
  • Capsule (hard and soft)
  • Soft gel
  • Solution
  • Cream

Administration

  • Oral
  • Mucosal (buccal, vaginal, nasal etc.)
  • Parenteral
  • Ophtalmics
  • Dermal

regulatory status

GMP certification, a National Formulary (NF) monograph is in the United States Pharmacopeia / National Formulary (USP/NF) version USP 40 – NF 35

download vitamin e-tpgs documentation

Our location

Address Uetikon, Raiffeisenstraße 4
77933 Lahr
Business Line Custom Manufacturing, APIs & Intermediates
Phone 49 7821 585 0
Market Pharmaceutical
Email info@uetikon.com
More information

Surface: 48, 000 m²

Lab surface: 700 m²

Capabilities:

  • Total reactor capacity: 92 m³
  • Reaction vessels: 1 to 6 300 L; temperature  -80°C to +250 °C
  • Multi-purpose state of the art cGMP facilty: 4 independent, vertical integrated production trains 800 L train, 2 x 3 000 L trains plus 1 x 3 000 L low temperature hydrogenation reactor and 6 000 L train
  • Classic two-floor layout Facility: 20 vessels with capacity between 800 and 6 000 L (glaslined and SS)
  • Autoclaves (operational range up to 100 bar)
  • Kilo-Lab: 3 reactors: 25 / 100 / 250 L

Flagship technologies:

  • Hydrogenation
  • Reductive amination
  • Organometallic reactions
  • Protected AADs (Aminoacid derivatives)
  • Carbonylation & Hydroformylation
  • Pressure aminolysis, other reactions under pressure
  • Cryogenic chemistry
  • Enantiopure synthesis
  • Cyanation high volumes (NaCN) C-C coupling
  • Reductions
  • Halogenation

Number of scientists: 25

Last inspections:

  • FDA 2018
  • The last inspection by the authorities took place on the 23rd November 2021 / Die letzte Inspektion der Aufsichtsbehörde fand am 23.11.2021 statt.

Certifications:

  • GMP
  • ISO 9001
  • ISO 50001

Seveso regulationInformation for the public / StörfallverordnungInformation der Öffentlichkeit

EcoVadis CSR Rating: Gold Certification