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Polythylene Oxide Excipient | Uses, Suppliers, and Specifications

Polyethylene Oxide is a synthetic, high molecular weight non-ionic homopolymer of ethylene oxide, represented by the formula (CH2CH2O)n, where n is the average number of oxyethylene groups (n is >2000). It may contain silicon dioxide or other additives as antioxidants. Polyethylene Oxide is supplied as a white or off-white, free-flowing powder with a slight ammoniacal odour.

Pharmacopoeial Compliance: USP-NF; Ph.Eur; B.P; J.P; I.P

Synonyms and Trade Names: Polyethylene Oxide; Polyoxyethylene; Polyox®

Uses and Applications: Mucoadhesive Polymer; Coating Polymer Base; Tablet Binder; Thickening Agent; and Sustained-Release Polymer

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POLYOX™ 301 - Dupont

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Description

Polyethylene oxide (PEO) is a polymer prepared by polymerization reaction (polycondensation) of ethylene oxide and water catalyzed by acidic or basic catalysts. It has two chemically synonymous names: poly(ethylene glycol) (PEG) and poly(oxyethylene) (POE). PEG has tended to refer to oligomers and polymers with a molecular weight below 20,000 g/mol, PEO to polymers with a molecular weight above 20,000 g/mol, and POE to a polymer of any molecular weight with the general formula H(OCH2CH2)nOH, commercially available over a wide range of molecular weights where n is the average number of repeating oxyethylene groups (OCH2CH2) typically from 2 to few 100. The low molecular weight members from n = 2 to n = 4 are diethylene glycol, triethylene glycol, and tetraethylene glycol, respectively, which are produced as pure compounds).

The USP-NF27 describes polyethylene oxide as a non-ionic homopolymer of ethylene oxide, represented by the formula (CH2CH2O)m where n represents the average number of oxyethylene groups. It may contain up to 3% of silicon dioxide or suitable antioxidant.

Polyethylene oxide occurs as a white to off-white, free-flowing powder, with a slight ammoniacal odour.

 

Chemical Structure & Identifiers

Chemical Structure

 

 

 

 


Chemical Name

Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated

CAS Registration Number [25322-68-3]
Empirical Formula H(OCH2CH2)nOH
Molecular weight 100 000 – >7 000 000 g/mol
EINCES Number 500-038-2
UNII Code (FDA) V46Y6OJ5QB (PEO 100 000)

 

Regulatory Status

Polyethylene oxide is currently listed in the USP-NF. It is also included in the FDA Inactive Ingredients Database (sustained- release tablets).

 

Physicochemical Properties

Angle of repose 34o
Density (true) 1.3 g/cm3
Melting point 65 – 70 oC
Moisture content <1%
Solubility Soluble in waler and a number of common organic solvents such as acetonitrile,  chloroform, and methylene chloride. Insoluble in aliphatic hydrocarbons
Viscosity 30 – 50 mPa s (5% aqueous solution)

 

Pharmacopeoeal Specifications

Test USP-NF
Identification +
Loss on drying 1.0
Silicon dioxide and nonsilicon dioxide residue on ignition 2.0
Silicon dioxide 3.0
Heavy metals 0.001
Free ethylene oxide 0.001

 

Applications in Pharmaceutical Formulations or Technology

Polyethylene oxide is used as a mucoadhesive, coating agent, tablet binder and, occasionally, as a thickening agent.

In tablets, concentrations of 5 – 25% have been used as binders to achieve sustained-release controlled matrices. Typically, higher molecular weight grades provide delayed drug release via the hydrophilic matrix approach.

Polyethylene oxide has also been shown to facilitate coarse extrusion for tableting as well as being an aid in hot-melt extrusion.

The relationship between swelling capacity and molecular weight is a good guide when selecting products for use in immediate or sustained release matrix formulations: higher molecular weights achieve greater sustaining effects compared with lower molecular weight grades.

Polyethylene oxide has been shown to be an excellent mucoadhesive polymer.

Low levels of polyethylene oxide are effective thickener, although alcohol is usually added to water- based formulations to provide improved viscosity stability.

Polyethylene oxide films demonstrate good lubricity when wet. This property has been utilized in the development of coatings for medical devices.

Polyethylene oxide can be radiation crosslinked in solution to produce a hydrogel that can he used in wound care applications.

 

Safety and Precautions

Polyethylene oxide polymers are nontoxic and nonimmunogenic, and approved by the US FDA as excipients. They are highly biocompatible, which makes them attractive as biomaterials. Animal studies suggest that polyethylene oxide has a low level of toxicity regardless of the route of administration. It is poorly absorbed from the gastrointestinal tract but appears to the completely and rapidly eliminated. The resins arc neither skin irritants nor sensitizers, and they do not cause eye irritation.

 

Stability and Storage Conditions

Store in tightly sealed containers in a cool, dry place. Avoid exposure to high temperatures as this can result in reduction in viscosity.

When handling the material, observe normal precautions appropriate on the circumstances and quantity of material handled. Polythylene oxide may form an  explosive dust-air mixture. Gloves, eye protection. a respirator, and other protective clothing should be worn.

 

Sustainability and Environmental Impact

Polyethylene oxide has not yet been assessed for sustainability and environmental impact.

Manufacturers & Suppliers

Dupont

POLYOX™ Polyethylene Oxide

Grade Approx. M.W Main application
POLYOX™ N-10 100 000 Osmotic pump tablets & Oral thin films
POLYOX™ N-80 200 000 Osmotic pump tablets & Oral thin films
POLYOX™ N-750 300 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release
POLYOX™ 250 600 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release
POLYOX™ 1105 900 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release
POLYOX™ N-12K 1 000 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release
POLYOX™ N-60K 2 000 000 Osmotic pump tablets, Hot melt extrusion, Abuse deterrence, and Sustained release
POLYOX™ 301 4 000 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release; Mucoadhesive & Gastroretentive
POLYOX™ COAGULANT 5 000 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release; Mucoadhesive & Gastroretentive
POLYOX™ 303 7 000 000 Oral thin films, Hot melt extrusion, Abuse deterrence, and Sustained release; Mucoadhesive & Gastroretentive

 

Additional Resources (Downloads)

References and Literature Used

[1] A. Car, Polyethylene Oxide, in: E. Drioli, L. Giorno (Eds.) Encyclopedia of Membranes, Springer Berlin Heidelberg, Berlin, Heidelberg, 2016, pp. 1-2.

[2] M.M. Crowley, F. Zhang, J.J. Koleng, J.W. McGinity, Stability of polyethylene oxide in matrix tablets prepared by hot-melt extrusion, Biomaterials, 23 (2002) 4241-4248.

[3] M.A. Howard, S.H. Neau, M.J. Sack, PEO and MPEG in high drug load extruded and spheronized beads that are devoid of MCC, Int J Pharm, 307 (2006) 66-76.

[4] J.D. Schulze, D.A. Ashiru, M.K. Khela, D.F. Evans, R. Patel, G.E. Parsons, M.D. Coffin, A.W. Basit, Impact of formulation excipients on human intestinal transit, The Journal of pharmacy and pharmacology, 58 (2006) 821-825.

[5] S. Thumma, S. Majumdar, M.A. ElSohly, W. Gul, M.A. Repka, Chemical stability and bioadhesive properties of an ester prodrug of Delta 9-tetrahydrocannabinol in poly(ethylene oxide) matrices: effect of formulation additives, Int J Pharm, 362 (2008) 126-132.

[6] S.B. Tiwari, A.R. Rajabi-Siahboomi, Extended-release oral drug delivery technologies: monolithic matrix systems, Methods in molecular biology (Clifton, N.J.), 437 (2008) 217-243.

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