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Polyglykol 3000 P by Clariant is a non-volatile slip, solubilizer, carrier, thickener and anti-static agent.
Polyglykol 3000 P offers softening, binding and non-irritating properties.
Polyglykol 3000 P provides low toxicity and no emulsifying effect.
CAS: 25322-68-3
MF: N/A
MW: 0
EINECS: 500-038-2
Polyglykol 3000 P is a white waxy solid powdered type polyethylene glycol at room temperature.
Polyglykol 3000 P is soluble in water and polar organic solvents like acetone or methanol.
Polyglykol 3000 P is insoluble in pure hydrocarbons and displays typical chemical reactions of alcohols/diols.
Polyglykol 3000 P shows very low water content and compatible with hard water.
Polyglykol 3000 P is used in skin-care products.
Polyglykol 3000 P are a family of linear polymers formed by a base-catalyzed condensation reaction with repeating ethylene oxide units being added to ethylene.
The molecular formula is (C2H4O)multH2O where mult denotes the average number of oxyethylene groups.
The molecular weight can range from 200 to several million corresponding to the number of oxyethylene groups.
The higher-molecular-weight materials (100 000 to 5 000 000) are also referred to as polyethylene oxides.
The average molecular weight of any specific Polyglykol 3000 P product falls within quite narrow limits (°5%).
The number of ethylene oxide units or their approximate molecular weight (e.g., PEG-4 or PEG-200) commonly designates the nomenclature of specific Polyglykol 3000 P.
Polyglykol 3000 P with amolecular weight less than 600 are liquid, whereas those of molecular weight 1000 and above are solid.
These materials are nonvolatile, water-soluble, tasteless, and odorless.
They are miscible with water, alcohols, esters, ketones, aromatic solvents, and chlorinated hydrocarbons, but immiscible with alkanes, paraffins, waxes, and ethers.
Any of several condensa-tion polymers of Polyglykol 3000 P with thegeneral formula HOCH2(CH2OCH2)nCH2OH orH(OCH2CH2)nOH.
Average molecular weightsrange from 200 to 6000.
Properties vary with molec-ular weight.
Clear colorless viscous liquid.
Polyglykol 3000 P are widely used in a variety of pharmaceutical formulations.
Generally, they are regarded as nontoxic and nonirritant materials.
Adverse reactions to Polyglykol 3000 P have been reported, the greatest toxicity being with glycols of low molecular weight.
However, the toxicity of Polyglykol 3000 P is relatively low.
Polyglykol 3000 P administered topically may cause stinging, especially when applied to mucous membranes.
Hypersensitivity reactions to Polyglykol 3000 P applied topically have also been reported, including urticaria and delayed allergic reactions.
The most serious adverse effects associated with Polyglykol 3000 P are hyperosmolarity, metabolic acidosis, and renal failure following the topical use of Polyglykol 3000 P in burn patients.
Topical preparations containing Polyglykol 3000 P should therefore be used cautiously in patients with renal failure, extensive burns, or open wounds.
Oral administration of large quantities of Polyglykol 3000 P can have a laxative effect.
Therapeutically, up to 4 L of an aqueous mixture of electrolytes and high-molecular-weight Polyglykol 3000 P is consumed by patients undergoing bowel cleansing.
Liquid Polyglykol 3000 P may be absorbed when taken orally, but the higher-molecular-weight Polyglykol 3000 P are not significantly absorbed from the gastrointestinal tract.
Absorbed Polyglykol 3000 P is excreted largely unchanged in the urine, although polyethylene glycols of low molecular weight may be partially metabolized.
The WHO has set an estimated acceptable daily intake of Polyglykol 3000 P at up to 10 mg/kg body-weight.
In parenteral products, the maximum recommended concentration of Polyglykol 3000 P is approximately 30% v/v as hemolytic effects have been observed at concentrations greater than about 40% v/v.
Polyglykol 3000 P are chemically stable in air and in solution, although grades with a molecular weight less than 2000 are hygroscopic.
Polyglykol 3000 P do not support microbial growth, and they do not become rancid.
Polyglykol 3000 P and aqueous polyethylene glycol solutions can be sterilized by autoclaving, filtration, or gamma irradiation.
Sterilization of solid grades by dry heat at 150℃ for 1 hour may induce oxidation, darkening, and the formation of acidic degradation products.
Ideally, sterilization should be carried out in an inert atmosphere.
Oxidation of Polyglykol 3000 P may also be inhibited by the inclusion of a suitable antioxidant.
If heated tanks are used to maintain normally solid Polyglykol 3000 P in a molten state, care must be taken to avoid contamination with iron, which can lead to discoloration.
The temperature must be kept to the minimum necessary to ensure fluidity; oxidation may occur if Polyglykol 3000 P are exposed for long periods to temperatures exceeding 50℃.
However, storage under nitrogen reduces the possibility of oxidation.
Polyglykol 3000 P should be stored in well-closed containers in a cool, dry place.
Stainless steel, aluminum, glass, or lined steel containers are preferred for the storage of liquid grades.
Polyglykol 3000 P Chemical Properties
Melting point: 64-66 °C
Boiling point: >250°C
Density: 1.27 g/mL at 25 °C
Vapor density: >1 (vs air)
Vapor pressure: <0.01 mm Hg ( 20 °C)
Refractive index: n20/D 1.469
Fp: 270 °C
Storage temp.: 2-8°C
Solubility H2O: 50 mg/mL, clear, colorless
Form: waxy solid
Color: White to very pale yellow
Specific Gravity: 1.128
PH: 5.5-7.0 (25℃, 50mg/mL in H2O)
Water Solubility: Soluble in water.
Sensitive: Hygroscopic
λmax: λ: 260 nm Amax: 0.6
λ: 280 nm Amax: 0.3
Merck: 14,7568
Stability: Stable. Incompatible with strong oxidizing agents.
LogP: -0.698 at 25℃
NIST Chemistry Reference: Polyglykol 3000 P (25322-68-3)
EPA Substance Registry System: Polyglykol 3000 P (25322-68-3)
Polyglykol 3000 P is a polymer which is hydrolyzed by ethylene oxide.
Polyglykol 3000 P has no toxicity and irritation.
Polyglykol 3000 P is widely used in various pharmaceutical preparations.
The toxicity of low molecular weight Polyglykol 3000 P is relatively large.
In general, the toxicity of diols is very low.
Topical application of Polyglykol 3000 P, especially mucosal drug, can cause irritant pain.
In topical lotion, Polyglykol 3000 P can increase the flexibility of the skin, and has a similar moisturizing effect with glycerin.
Diarrhoea can occur in large doses of oral administration.
In injection, the maximum Polyglykol 3000 P concentration is about 30% (V/V).
Hemolysis could occur when the concentration is more than 40% (V/V).
The USP32–NF27 describes Polyglykol 3000 P as being an addition polymer of ethylene oxide and water.
Polyglykol 3000 P grades 200–600 are liquids; grades 1000 and above are solids at ambient temperatures.
Liquid grades (PEG 200–600) occur as clear, colorless or slightly yellow-colored, viscous liquids.
They have a slight but characteristic odor and a bitter, slightly burning taste.
Polyglykol 3000 P can occur as a solid at ambient temperatures.
Solid grades (PEG>1000) are white or off-white in color, and range in consistency from pastes to waxy flakes.
They have a faint, sweet odor.
Grades of PEG 6000 and above are available as freeflowing milled powders.
Polyglykol 3000 P is another osmotic laxative that is colorless and tasteless once it is mixed.
Application in Biomedicine
Polyglykol 3000 P is also known as polyoxirane (PEO).
Polyglykol 3000 P is a linear polyether obtained by ring opening polymerization of ethylene oxide.
The main uses in the field of biomedicine are as follows:
Contact lens liquid.
The viscosity of polyethylene glycol solution is sensitive to the shear rate and it is not easy for bacteria to grow on Polyglykol 3000 P.
Synthetic lubricants.
The condensation polymer of ethylene oxide and water.
Polyglykol 3000 P is a cream matrix for preparing water-soluble drugs.
Polyglykol 3000 P can also be used as a solvent for acetylsalicylic acid and caffeine, which is difficult to dissolve in water.
Drug sustained-release and immobilized enzyme carrier.
The Polyglykol 3000 P solution is applied to the outer layer of the pill to control the diffusion of drugs in the pill so as to improve the efficacy.
Surface modification of medical polymer materials.
The biocompatibility of medical polymer materials in contact with blood can be improved by adsorption, interception and grafting of two amphiphilic copolymers containing Polyglykol 3000 P on the surface of medical polymers.
Polyglykol 3000 P can make the membrane of the alkanol contraceptive pill.
Polyglykol 3000 P can make hydrophilic anticoagulant polyurethane.
Polyglykol 3000 P is an osmotic laxative.
Polyglykol 3000 P can increase osmotic pressure and absorb moisture in the intestinal cavity, which makes the stool soften and increase in volume, resulting in bowel movement and defecation.
Denture fixing agent.
Polyglykol 3000 Pnontoxic and gelatinous nature can be used as a component of denture fixer.
Polyglykol 3000 P are commonly used to promote cell fusion or protoplast fusion and help organisms (such as yeasts) to take DNA in transformation.
PEG absorbs water from the solution, so Polyglykol 3000 P is also used to concentrate the solution.
Pharmaceutical Applications
Polyglykol 3000 P are widely used in a variety of pharmaceutical formulations, including parenteral, topical, ophthalmic, oral, and rectal preparations.
Polyglykol 3000 P has been used experimentally in biodegradable polymeric matrices used in controlled-release systems.
Polyglykol 3000 P are stable, hydrophilic substances that are essentially nonirritant to the skin;They do not readily penetrate the skin, although the Polyglykol 3000 P are water-soluble and are easily removed from the skin by washing, making them useful as ointment bases.
Solid grades are generally employed in topical ointments, with the consistency of the base being adjusted by the addition of liquid grades of Polyglykol 3000 P.
Mixtures of Polyglykol 3000 P can be used as suppository bases,for which they have many advantages over fats.
For example, the melting point of the suppository can be made higher to withstand exposure to warmer climates; release of the drug is not dependent upon melting point; the physical stability on storage is better; and suppositories are readily miscible with rectal fluids.
Polyglykol 3000 P have the following disadvantages: they are chemically more reactive than fats; greater care is needed in processing to avoid inelegant contraction holes in the suppositories; the rate of release of water-soluble medications decreases with the increasing molecular weight of the polyethylene glycol; and Polyglykol 3000 P tend to be more irritating to mucous membranes than fats.
Aqueous Polyglykol 3000 P solutions can be used either as suspending agents or to adjust the viscosity and consistency of other suspending vehicles.
When used in conjunction with other emulsifiers, Polyglykol 3000 P can act as emulsion stabilizers.
Liquid Polyglykol 3000 P are used as water-miscible solvents for the contents of soft gelatin capsules.
However, they may cause hardening of the capsule shell by preferential absorption of moisture from gelatin in the shell.
In concentrations up to approximately 30% v/v, Polyglykol 3000 P have been used as the vehicle for parenteral dosage forms.
In solid-dosage formulations, higher-molecular-weight Polyglykol 3000 P can enhance the effectiveness of tablet binders and impart plasticity to granules.
However, they have only limited binding action when used alone, and can prolong disintegration if present in concentrations greater than 5% w/w.
When used for thermoplastic granulations,a mixture of the powdered constituents with 10–15% w/w Polyglykol 3000 P is heated to 70–75°C.
The mass becomes pastelike and forms granules if stirred while cooling.
This technique is useful for the preparation of dosage forms such as lozenges when prolonged disintegration is required.
Polyglykol 3000 P can also be used to enhance the aqueous solubility or dissolution characteristics of poorly soluble compounds by making solid dispersions with an appropriate polyethylene glycol.
Animal studies have also been performed using Polyglykol 3000 P as solvents for steroids in osmotic pumps.
In film coatings, solid grades of Polyglykol 3000 P can be used alone for the film-coating of tablets or can be useful as hydrophilic polishing materials.
Solid grades are also widely used as plasticizers in conjunction with film-forming polymers.
The presence of Polyglykol 3000 P in film coats, especially of liquid grades, tends to increase their water permeability and may reduce protection against low pH in enteric-coating films.
Polyglykol 3000 P are useful as plasticizers in microencapsulated products to avoid rupture of the coating film when the microcapsules are compressed into tablets.
Polyglykol 3000 P grades with molecular weights of 3000 and above can be used as lubricants, particularly for soluble tablets.
The lubricant action is not as good as that of magnesium stearate, and stickiness may develop if the material becomes too warm during compression.
An antiadherent effect is also exerted, again subject to the avoidance of overheating.
Polyglykol 3000 P have been used in the preparation of urethane hydrogels, which are used as controlled-release agents.
Polyglykol 3000 P has also been used in insulin-loaded microparticles for the oral delivery of insulin;it has been used in inhalation preparations to improve aerosolization;Polyglykol 3000 P nanoparticles have been used to improve the oral bioavailability of cyclosporine;it has been used in self-assembled polymeric nanoparticles as a drug carrier;and copolymer networks of Polyglykol 3000 P grafted with poly(methacrylic acid) have been used as bioadhesive controlled drug delivery formulations.
Uses
Polyglykol 3000 P is a binder, coating agent, dispersing agent, flavoring adjuvant, and plasticizing agent that is a clear, colorless, viscous, hygroscopic liquid resembling paraffin (white, waxy, or flakes), with a ph of 4.0–7.5 in 1:20 concentration.
Polyglykol 3000 P is soluble in water (mw 1,000) and many organic solvents.
Polyglykol 3000 P is a binder, solvent, plasticizing agent, and softener widely used for cosmetic cream bases and pharmaceutical ointments.
Pegs are quite humectant up to a molecular weight of 500.
Beyond this weight, their water uptake diminishes.
Used in conjunction with carbon black to form a conductive composite.
Polymer nanospheres of Polyglykol 3000 P were used for drug delivery.
Polyglykol 3000 P molecules of approximately 2000 monomers.
Polyglykol 3000 P is used in various applications from industrial chemistry to biological chemistry.
Recent research has shown Polyglykol 3000 P maintains the ability to aid the spinal cord injury recovery process, helping the nerve impulse conduction process in animals.
In rats, Polyglykol 3000 P has been shown to aid in the repair of severed sciatic axons, helping with nerve damage recovery.
Polyglykol 3000 P is industrially produced as a lubricating substance for various surfaces to reduce friction.
Polyglykol 3000 P is also used in the preparation of vesicle transport systems in with application towards diagnostic procedures or drug delivery methods.
H2 histamine receptor antagonist, anti-ulcer agent.
A polymer used to precipitate proteins, viruses, DNA and RNA.
Preparation
The ring-opening polymerization of ethylene oxide is readily effected by a variety of ionic reagents and several types of polymer have been prepared.
For commercial purposes, poly(ethylene oxide)s of low molecular weight and of very high molecular weight are of interest.
(a) Low molecular weight polymers
Poly(ethylene oxide)s of low molecular weight, i.e. below about 3000, are generally prepared by passing ethylene oxide into ethylene glycol at 120-150C and about 0.3 MPa (3 atmospheres) pressure, using an alkaline initiator such as sodium hydroxide.
Anionic polymerization proceeds according to the following scheme:
The polymers produced by these methods are thus terminated mainly by hydroxy groups (a few unsaturated end-groups are also formed) and are often referred to as poly(ethylene glycol)s.
Polyglykol 3000 P with molecular weights in the range 200-600 are viscous liquids which find use as surfactants in inks and paints and as humectants.
At molecular weights above about 600, Polyglykol 3000 P are low-melting waxy solids, uses of which include pharmaceutical and cosmetic bases, lubricants and mould release agents.
Polyglykol 3000 P may be noted that homogeneous cationic polymerization of ethylene oxide also generally leads to low molecular weight products; typical initiators include aluminium chloride, boron trifluoride and titanium tetrachloride.
Systems of this type are not utilized on a commercial scale.
(b) High molecular weight polymers
Poly(ethylene oxide)s of molecular weight ranging from about 100000 to 5 x 106 and above are available.
Details of the techniques used to manufacture these polymers have not been disclosed, but the essential feature is the use of (generally) heterogeneous initiator systems.
Effective initiators are mainly of two types, namely alkaline earth compounds (e.g. carbonates and oxides of calcium, barium and strontium) and organometallic compounds (e.g. aluminium and zinc alkyls and alkoxides, commonly with added coinitiators).
Unlike the low molecular weight poly(ethylene oxide)s, the high molecular weight polymers are tough and extensible.
They are highly crystalline, with a melting point of 66C.
Unlike most water-soluble polymers, the high molecular weight poly(ethylene oxide)s may be melt processed; they may be injection moulded, extruded and calendered without difficulty.
Poly(ethylene oxide)s are soluble in an unusually broad range of solvents, which includes water; chlorinated hydrocarbons such as carbon tetrachloride and methylene dichloride; aromatic hydrocarbons such as benzene and toluene; ketones such as acetone and methyl ethyl ketone; and alcohols such as methanol and isopropanol.
There is an upper temperature limit of solubility in water for the high molecular weight poly(ethylene oxide)s; this varies with concentration and molecular weight but is usually between 90 and 100C.
Water-solubility is due to the ability of the polyether to form hydrogen bonds with water; these bonds are broken when the temperature is raised, restoring the anhydrous polymer which is precipated from the solution.
High molecular weight poly(ethylene oxide)s find use as water-soluble packaging films and capsules for such products as laundry powders, colour concentrates, tablets and seeds.
In solution, the polymers are used as thickeners in pharmaceutical and cosmetic preparations, textile sizes and latex stabilizers.
Manufacturing Process
Polyglykol 3000 P was obtained by polymerization of ethylene oxide in an autoclave at 80-100°C using as a catalyst dipotassium alcogolate of polyethylene glycol 400.
Dipotassium alcogolate of Polyglykol 3000 P was synthesized by a heating of the dry mixture of polyethylene glycol 400 and potassium hydroxide.
The molecular weight of polymer was regulated by the ratio of monomer:catalyst.
Purification Methods
PEG is available commercially as a powder or as a solution in various degrees of polymerization depending on the average molecular weight, e.g.
PEG 400 and PEG 800 have average molecular weights of 400 and 800, respectively.
They may be contaminated with aldehydes and peroxides.
Solutions deteriorate in the presence of air due to the formation of these contaminants.
Methods available for purification are as follows: Procedure A: A 40% aqueous solution of PEG 400 (2L, average molecular weight 400) is de-aerated under vacuum and made 10mM in sodium thiosulfate.
After standing for 1hour at 25o, the solution is passed through a column (2.5x20cm) of mixed-bed R-208 resin which has a 5cm layer of Dowex 50-H+ at the bottom of the column.
The column was previously flushed with 30% aqueous MeOH, then thoroughly with H2O.
A flow rate of 1mL/minute is maintained by adjusting the fluid head.
The first 200mL are discarded, and the effluent is then collected at an increased flow rate.
The concentration of PEG solution is checked by density measurement, and it is stored (preferably anaerobically) at 15o.
Procedure B: A solution of PEG 800 (500g in 805mL H2O) is made 1mM in H2SO4 and stirred overnight at 25o with 10g of treated Dowex 50-H+ (8% crosslinked, 20-50 mesh).
The resin, after settling, is filtered off on a sintered glass funnel.
The filtrate is treated at 25o with 1.5g of NaBH4 (added over a period of 1minute) in a beaker with tight but removable lid through which a propeller-type mechanical stirrer is inserted and continuously flushed with N2.
After 15minutes, 15g of fresh Dowex 50-H+ are added, and the rate of stirring is adjusted to maintain the resin suspended.
The addition of an equal quantity of Dowex 50-H+ is repeated and the reaction times are 30 and 40minutes.
The pH of a 1 to 10 dilution of the reaction mixture should remain above pH 8 throughout.
If it does not, more NaBH4 is added or the addition of Dowex 50-H+ is curtailed.
(Some samples of PEG can be sufficiently acidic, at least after the hydrolysis treatment, to produce a pH that is too low for efficient reduction when the above ratio of NaBH4 to Dowex 50-H+ is used.)
About 30minutes after the last addition of NaBH4, small amounts of Dowex 50-H+ (~0.2g) are added at 15minute intervals until the pH of a 1 to 10 dilution of the solution is less than 8.
After stirring for an additional 15minutes the resin is allowed to settle, and the solution is transferred to a vacuum flask for brief de-gassing under a vacuum.
The de-gassed solution is passed through a column of mixed-bed resin as in procedure A.
The final PEG concentration would be about 40% w/v.
Assays for aldehydes by the purpural method and of peroxides are given in the reference below.
Treatment of Dowex 50-H+ (8% crosslinked, 20-50 mesh): The Dowex (500g) is suspended in excess 2N NaOH, and 3mL of liquid Br2 is stirred into the solution.
After the Br2 has dissolved, the treatment is repeated twice, and then the resin is washed with 1N NaOH on a sintered glass funnel until the filtrate is colourless.
The resin is then converted to the acid form (with dilute HCl, H2SO4 or AcOH as required) and washed thoroughly with H2O and sucked dry on the funnel.
The treated resin can be converted to the Na salt and stored.
Reactivity Profile
Polyglykol 3000 P is heat-stable and inert to many chemical agents; Polyglykol 3000 P will not hydrolyze or deteriorate under normal conditions.
Polyglykol 3000 P has a solvent action on some plastics.
Biochem/physiol Actions
Polyglykol 3000 P (PEG) helps in the purification and crystal growth of proteins and nucleic acids.
PEG also interacts with cell membrane, thereby allowing cell fusion.
Toxicity Evaluation
Many years of human experience in the workplace and in the use of consumer products containing Polyglykol 3000 P have not shown any adverse health effects, except in situations where very high doses are administered to hypersusceptible individuals or persons with underlying diseases.
Incompatibilities
The chemical reactivity of Polyglykol 3000 P is mainly confined to the two terminal hydroxyl groups, which can be either esterified or etherified.
However, all grades can exhibit some oxidizing activity owing to the presence of peroxide impurities and secondary products formed by autoxidation.
Liquid and solid Polyglykol 3000 P grades may be incompatible with some coloring agents.
The antibacterial activity of certain antibiotics is reduced in Polyglykol 3000 P bases, particularly that of penicillin and bacitracin.
The preservative efficacy of the parabens may also be impaired owing to binding with Polyglykol 3000 P.
Physical effects caused by Polyglykol 3000 P bases include softening and liquefaction in mixtures with phenol, tannic acid, and salicylic acid.
Discoloration of sulfonamides and dithranol can also occur, and sorbitol may be precipitated from mixtures.
Plastics, such as polyethylene, phenolformaldehyde, polyvinyl chloride, and cellulose-ester membranes (in filters) may be softened or dissolved by Polyglykol 3000 P.
Migration of Polyglykol 3000 P can occur from tablet film coatings, leading to interaction with core components.
Synonyms
1,2-ethanediol,homopolymer
2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-Poly(oxy-1;Alcox E 160;Alcox E 30
alcoxe30
Poly(ethylene oxide),approx. M.W. 600,000
Poly(ethylene oxide),approx. M.W. 200,000
Poly(ethylene oxide),approx. M.W. 900,000
