Polyethylene Glycol 400

Category

Stabilizer; Plasticizer; Base Agents; Coating Agents; Wetting Agents; Emulsifier; Excipient; Collapsing Agents; Solvent; Dissolving aid

Molecular Formula

HOCH2(CH2OCH2)nCH2OH, n=7~9

Grade

Pharmceutical Excipients

Description

Polyethylene glycol as being an addition polymer of ethylene oxide and water. Polyethylene glycol 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. PEG 600 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 6002 and above are available as freeflowing milled powders.

UNII

B697894SGQ

Chemical Name

Polyethylene Glycol 400

CAS Number

25322-68-3

Synonyms

Macrogol 400

Administration route

Intramuscular injection; Intravenous injection; Nasal spray; Ophthalmic; Topical application; Oral

Dosage Form

Injections, sprays, drops, syrups

Stability and Storage Conditions

Store in airtight container.

Commonly used amount and the maximum amount

The maximum dosage of each route of administration: Oral: 2.31g; General external use: 700mg/g; Rectum, cavity, urethra: 3.07g; Dental external use and oral cavity: 200mg/g; Intravenous injection: 3, 2g; Local anesthesia injection; 7.881mg; Sublingual administration: 720mg/g; Other external use: 50mg; Intramuscular injection: 3.2g; Subcutaneous injection: 3.2g; Otolaryngological preparations: 50mg/mL.

Source and Preparation

Polyethylene glycol polymers are formed by the reaction of ethylene oxide and water under pressure in the presence of a catalyst.

Applications

Polyethylene glycols (PEGs) are widely used in a variety of pharmaceutical formulations, including parenteral, topical, ophthalmic, oral, and rectal preparations. Polyethylene glycol has been used experimentally in biodegradable polymeric matrices used in controlled-release systems.

Safety

LD50 (guinea pig, PO): 15.7g/kg; LD50 (mouse, IP): 10.0g/kg; LD50 (mouse, IV): 8.6g/kg; LD50 (mouse, PO): 28.9g/kg ; LD50 (rabbit, PO): 26.8g/kg; LD50 (rat, IP): 9.7g/kg; LD50 (rat, IV): 7.3g/kg.

Incompatibilities

The chemical reactivity of polyethylene glycols 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 polyethylene glycol grades may be incompatible with some coloring agents. The antibacterial activity of certain antibiotics is reduced in polyethylene glycol bases, particularly that of penicillin and bacitracin. The preservative efficacy of the parabens may also be impaired owing to binding with polyethylene glycols. Physical effects caused by polyethylene glycol 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 polyethylene glycols. Migration of polyethylene glycol can occur from tablet film coatings, leading to interaction with core components.