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Vitamin E TPGS

Vitamin E TPGS
Vitamin E TPGS
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Product Code : 9002-96-4
Brand Name : Shanghai Lianlu
Price And Quantity
  • Minimum Order Quantity
  • 1
  • Unit of Measure
  • Kilograms/Kilograms
Product Specifications
  • HS Code
  • 29362800
  • Molecular Weight
  • 1513 Grams (g)
  • Place of Origin
  • China
  • Storage
  • Room Temperature
  • Molecular Formula
  • C33H54O5.(C2H4O)n
  • Application
  • Other, Cosmetic Industry, Pharmaceutical Industry
  • Form
  • Solid
Product Description

 The percentages of Free PEG, mono-TPGS, and bis-TPGS could be customized. 

The Vitamin E TPGS is a water soluble derivative of natural Vitamin E. Apart from this, they are white to brownish colored waxy solid acting as an excipient. These chemicals are highly suitable for making edible items that requires transparent appearance like soft capsules, excipients and emulsifying agents. The Vitamin E TPGS is a non ionic surfactant that is widely used in the pharmaceutical industries for drugs that are poorly soluble. They also acts as an absorption enhancer, antioxidant and an intermediate for lipid based drug formulation.

Features:

  • Have low melting point of around 38 degrees Celsius

  • Possesses amphiphilic properties

  • Appears as white to light tan colored solid

  Emulsifier - TPGS has amphiphilc properties and is therefore used as emulsifier for nutraceuticals and pharmaceuticals (Lehr 2005). Emulsifier for injectable formulations

DRUG DELIVERY SYSTEM

·         Drug solubilizer – It directly increases the bioavailability and delivery of poorly soluble drugs

·         Protects drugs from crystallization Provide Vitamin E or poorly soluble nutraceuticals in liquid dosage form Reduces drug sensitivity on skin and tissues

·         Acts as a vehicle in semi-dosage form and also for pulmonary (inhalation) dosage form

·         Carrier for wound care and treatment

·         A thermal binder in melt granulations / extrusion process

ABSORPTION ENHANCER

ANTIOXIDANT

Vehicle for lipid - based drug delivery - Vitamin E TPGS is an important extension to a range of drug delivery products

Source of natural Vitamin E - used in pharmaceutical formulations as well as dietary supplements Extensively used in solid, topical and ophthalmic dosage forms

AMPHIPHILIC (SURFACE-ACTIVE) PROPERTIES

Vitamin E TPGS is amphiphile, that is it has a dual nature. Part of the molecule exhibits hydrophilicity and the other lipophilicity. General accepted view is that the polyethylene glycol portion serves as the hydrophilic polar head (water soluble), while the tocopherol succinate portion serves as the lipophilic alkyl tail (water insoluble).

STABILITY

Vitamin E TPGS is stable when exposed to oxygen, heat, light, or oxidizing agents. It is unstable to alkali. Vitamin E TPGS is known to be stable excipient with a shelf-life of 4 years when stored in the original unopened container at room temperature. Vitamin E TPGS is stable under the conditions of heat sterilization. Stability data will be available soon.

SAFETY AND TOXICOLOGY

Regarding the safety of Vitamin E TPGS, various studies have been conducted in the last decades. EFSA (European Food Safety Authority) has conducted studies to assess the safety and bioavailability of Vitamin E TPGS for use in food particularly for nutritional / medical purposes. From toxicology studies, an overall no-observed-adverse-effect level (NOAEL) of 1000 mg / kg body weight per day can be derived. Vitamin E TPGS is not genotoxic. Also approved by US-FDA (United States - Food and Drug Administration). Vitamin E TPGS is a non-toxic multi-role excipient used in pharmaceutical and nutraceutical applications. Vitamin E TPGS has been shown to improve the bioavailability of poorly absorbed drugs by acting as an absorption and permeability enhancer. As a water soluble compound, Vitamin E TPGS can be used to dissolve lipophilic and other insoluble ingredients and can also used as an efficient source of natural Vitamin E, both for therapeutic and nutritional purposes.

Vitamin E TPGS is a multi role excipient used in nutraceutical and pharmaceutical applications.

Vitamin E TPGS has shown proven and recognized properties to improve bioavailability of poorly absorbed drugs vitamins micro-nutrients acting as an absorption and permeability enhancer and to developp Self Emulsifying Drug Delivery System (SEEDS) for poorly soluble drugs as an emulsifier. As a water soluble compound, Vitamin E TPGS is also used as an efficient source of natural Vitamin E, both for therapeutic purposes and nutrition. In Addition Vitamin E TPGS has physical properties that make it a relevant plasticizer for innovative technologies in the pharmaceutical industry such as hot melt extrusion.

A lot of pharmaceutical companies have incorporated Vitamin E TPGS mainly in oral dosage forms for years but new delivery applications are being investigated:

parenteral delivery

topical delivery

- dermal

- nasal

- pulmonary

 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:

l  solubilizer of poorly soluble drugs

l  absorption enhancer

l  emulsifier

l  vehicle for lipid-based drug formulation

l  antioxidant

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

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​ 

Vitamin E TPGS

Alpha Tocopheryl Polyethylene Glycol Succinate (TPGS) is widely used as a water-soluble vitamin E formulation. TPGS is synthesized from the lipid-soluble antioxidant, α-tocopherol (vitamin E) by grafting to a polyethylene glycol (PEG) oligomer through a succinate diester linker. Vitamin-E TPGS is amphiphile that is it has a dual nature. Vitamin-E TPGS is prepared from two different sources - Natural and synthetic vitamin E. 

Applications 

l  Emulsifier

l  Drug delivery system

l  Dietary supplements

l  Food and beverages

l  Personal care

l  Cosmetics

l     Animal nutrition

D-α-Tocopheryl polyethylene glycol 1000 succinate (simply TPGS or Vitamin E TPGS) is formed by the esterification of Vitamin E succinate with polyethylene glycol 1000. As novel nonionic surfactant, it exhibits amphipathic properties and can form stable micelles in aqueous vehicles at concentration as low as 0.02 wt%. It has been widely investigated for its emulsifying, dispersing, gelling, and solubilizing effects on poorly water-soluble drugs. It can also act as a P-glycoprotein (P-gp) inhibitor and has been served as an excipient for overcoming multidrug resistance (MDR) and for increasing the oral bioavailability of many anticancer drugs. Since TPGS has been approved by FDA as a safe pharmaceutic adjuvant, many TPGS-based drug delivery systems (DDS) have been developed. In this review, we discuss TPGS properties as a P-gp inhibitor, solubilizer/absorption and permeation enhancer in drug delivery and TPGS-related formulations such as nanocrystals, nanosuspensions, tablets/solid dispersions, adjuvant in vaccine systems, nutrition supplement, plasticizer of film, anticancer reagent and so on. This review will greatly impact and bring out new insights in the use of TPGS in DDS. 

Uses:

·         Pharmaceutical – it greatly enhances the absorption, bioavailability and effectiveness of pharmaceutical ingredients (APIs).

·         Dietary Supplements – it is used to formulate supplements, especially those created to improve absorption of vitamin E and other lipophilic nutrients and nutraceuticals.

·         Food and Beverage – it can be employed to fortify foods and beverages, sports drinks, water and juices.

·         Personal Care – it serves as an ethanol free, hypoallergenic, non-irritating emulsifier/excipient in personal care and cosmetic applications.

·         Animal Nutrition Products – it supplies a highly absorbable and bioavailable vitamin E for animals that do not efficiently absorb traditional forms of vitamin E.

l  Emulsifier/ Solubilizer of poorly soluble drugs

l  Vehicle for lipid-based drug formulation

l     Dietary supplements/ Animal nutrition

l  Food and beverages

l  Personal care/ Antioxidant

l  Cosmetics

l  Absorption enhancer

Technical Specifications: 

Test items

In-house Standard

Analytical method

Description

Waxy solid, white to light brown

Visual method

Identification

Corresponds to reference

GC

Solubility in water

20% Min (Clear solution)

USP39

Acid value

0.27ml

USP39

Specific Rotation

+24

USP<781S>

Heavy metals

Cadmium

Arsenic

Lead

Mercur

10ppm

1ppm
1ppm

3ppm
1ppm

USP<231>

ICP-MS

ICP-MS

ICP-MS

AAS

Residual solvents

Ethanol

Ethyl Acetate

Complies with USP39 Requirement

5000ppm 3000ppm

USP<467> 

PEG1000

20%

Calculation

Assay (D-a-tocopherol)

25.0%

USP39 

Microbiological Profile

Total Plate Count

Yeast & Mold

E.coli

Salmonella

1000cfu/g
100cfu/g

Negative

Negative

USP<61>


Trade Information
  • FOB Port
  • Shanghai
  • Payment Terms
  • Telegraphic Transfer (T/T)
  • Supply Ability
  • 5MT Per Month
  • Delivery Time
  • 2 Week
  • Sample Available
  • Yes
  • Sample Policy
  • Free samples available with shipping and taxes paid by the buyer
  • Packaging Details
  • 25KG/drum
  • Main Export Market(s)
  • Western Europe, North America
  • Certifications
  • KOSHER, HALAL

SHANGHAI LIANLU INDUSTRIAL CO., LTD.
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