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Excipients for Drug Formulation

Kollisolv® PEG 400

Excellent solvent for a large number of substances that do not readily dissolve in water

The low-molecular weight liquid polyethylene glycol Kollisolv® PEG 400 is an excellent solvent for a large number of substances that do not readily dissolve in water. They are therefore widely used as solvents and solubilising agents for active substances and excipients in liquid and semi-solid preparations. It is the ability of PEGs to form complexes with active substances that is responsible for their excellent solvent power.

However, equilibrium constants for complex formation vary considerably from one substance to another, and certain drugs such as Penicillin G and Bacitracin can even become inactivated. The effect of the polyethylene glycol on the efficacy and absorbtion of a drug must therefore always be determined in tests. With regard to incompatible substances, please see the remarks in the European Pharmacopoeia, Vol. II/3, Monographs M1, Macrogol 300, p. 3. Polyethylene glycols can also be used to adjust the viscosity of liquid pharmaceutical preparations and ointments, to modify their absorption properties and to stabilise the preparation.

Why choose Kollisolv® PEGs

  • Pharmaceutical grade IPEC GMP compliance
  • Versatile, water-miscible solvent vehicle for use in a multitude of drug formulations ranging from liquid and solid oral dosage forms to topical ointments and suppositories
  • Can be paired with BASF surfactants (for example Kolliphor® RH 40) to promote solubilization of poorly water-soluble APIs
  • May be formulated with BASF polymers (for example Kollidon® 12 PF) for crystallization inhibition
  • Combine low and high molecular weight PEG excipients to customize a waterwashable formulation base for topical ointments
  • Can also be used as a chemical intermediate in drug formulation
Product Details
Chemical name: Polyethylene glycol
Trivial names: Polyethylene glycol, macrogol, polyglycol, polyoxyethylene and polydiol
Former tradename: Lutrol® E 400
CAS-No: 25322-68-3
INCI: PEG-8
Regulatory Status: Kollisolv® PEG 400 meets the requirements of the current monograph for Macrogol in Ph. Eur., Polyethyleneglycol in USP/NF and Polyethyleneglycol in JP.
Applications: The product is mainly applied as solvent for oral and topical preparations.
Description: Kollisolv® PEG 400 is colourless, almost odourless and tasteless liquids at room temperature. The products are manufactured by alkali-catalysed polymerisation of ethylene oxide with subsequent neutralisation of the catalyst.
Solubility:

Kollisolv® PEG 400 is

  • readily soluble in water, ethanol, acetone, glycols and chloroform
  • insoluble in ether, paraffin, oils and fats

Learn more about Kollisolv® PEG 400

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