Vitamin E TPGS
Technical characteristics
Vitamin E TPGSChemical Name: D-α tocopheryl polyethylene glycol 1000 succinate
Other Names: Tocofersolan, Tocophersolan, TPGS, Vitamin E TPGS
CAS: 9002-96-4
US DMF: type IV
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
CDMO Lahr
Germany77933 Lahr
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 regulation – Information for the public / Störfallverordnung – Information der Öffentlichkeit
EcoVadis CSR Rating: Gold Certification
