Skip to main content

Health Care Active Pharmaceutical Ingredients:
Polyethylene Glycols


PEG APIs to bring constipation relief in Laxative formulations

Gentle on the body, for better quality of life

Key benefits of PEG based laxatives:
  • Absence of side effects compared with other types of osmotic laxatives such as lactulose
  • Gentle on the body - because the PEG is almost completely excreted, with very low levels of absorption by the digestive tract
  • Suitable for long-term use by children as young as two years old for special PEG laxatives

Clariant Image Baking Soda 20221101

This type of laxative formulation thus improves quality of life for millions around the world, as part of treatment for chronic constipation in adults and children, during pregnancy, before or after surgery or as preparation for colonoscopy continue to improve people’s health.

Our laxative API PEGs are compliant with the general requirements of three of the most important international pharmacopoeias (the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopoeia–National Formulary (USP-NF), and the Japanese Pharmacopoeia (JP)). With more than 25 years’ experience as a producer, we maintain very rigorous production standards. We use dedicated reactors to avoid cross contamination and our production facilities undergo comprehensive audits for GMP compliance.

Excellence in production

Clariant is committed on Excellence in production with a global production, technical and regulatory footprint. Clariant also offers PEGs as APIs in various physical forms
  • Flakes
  • Sprayed powders
  • Milled powders

PEG API as GMP-compliant demulcent for ophthalmic solutions

Without the right tear composition and amount, people may suffer from conditions which can cause stinging, burning, fatigue and redness of the eyes. Factors such as contact lens wear, increased visual display use and environmental exposure have led to a significant increase in the incidence of eye conditions within modern society1, 2. Lubricant eye drops containing PEG 400 provide temporary relief to the patient. PEG 400 provides a lubrication effect and acts as a demulcent active pharmaceutical ingredient (API) in such formulations3. In the sensitive eye area, high quality ingredients are required in ophthalmic formulations.

Clariant provides this with Polyglykol 400 J which is a liquid PEG API grade product, produced under ICH Q7 conditions and in a facility certified to meet GMP requirements by the German competent authorities. It is specified according to the requirements of the international ICH guidelines and monographs. With its additional microbiological specification (incl. endotoxins) special formulation requirements can be fulfilled.

1. Stapleton F et al. TFOS DEWS II Epidemiology report. The Ocular Surface 15 (2017) 334-365. 2. Perry HD. Dry Eye Disease: Pathophysiology, Classification and Diagnosis. American Journal for Managed Care 2008;14: 79 – 87 3. FDA, Final Administrative Order OTC000023, “Over-the-Counter Monograph 018: Ophthalmic Drug Products for Over-the-Counter Use,” Section M018.12(d)(3) (available at: https://dps.fda.gov/omuf/monographsearch/monograph_m018).

Clariant Image Eyedrop in blue transparent container 20220823

Resources

Related products

  • Polyglykol 3350 P*
    Polyglykol 3350 P is a milled PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The powder form supports the homogeneous mixing with other materials within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    more
  • Polyglykol 3350 PS
    Polyglykol 3350 PS is a sprayed PEG API grade powder product, with a mean particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
    more
  • Polyglykol 3350 PSB
    Polyglykol 3350 PS is a sprayed PEG API grade powder product, with a coarse particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
    more
  • Polyglykol 3350 PSE
    Polyglykol 3350 PSE is a sprayed PEG API grade powder product, with a mean particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).With its low Ethylene oxide and Dioxane specification limits special formulation requirements could be fulfilled.
    more
  • Polyglykol 3350 PSR
    Polyglykol 3350 PSR is a sprayed PEG API grade powder product, with a coarse particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).With its low Ethylene oxide and Dioxane specification limits special formulation requirements could be fulfilled.
    more
  • Polyglykol 3350 PST
    Polyglykol 3350 PST is a sprayed PEG API grade powder product, with a fine particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).With its low Ethylene oxide and Dioxane specification limits special formulation requirements could be fulfilled.
    more
  • Polyglykol 3350 S*
    Polyglykol 3350 S is a flaked PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The flaked form enables easier handling of the material within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    more
  • Polyglykol 400 J
    Polyglykol 400 J is a liquid PEG API grade product, produced under ICH Q7 conditions and GMP certified by the German authorities. It is specified according to the requirements of the international ICH guidelines and monographs. With its additional microbiological specification (incl. endotoxins) special formulation requirements could be fulfilled.
    more
  • Polyglykol 4000 P*
    Polyglykol 4000 P is a milled PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The powder form supports the homogeneous mixing with other materials within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    more
  • Polyglykol 4000 PS
    Polyglykol 4000 PS is a sprayed PEG API grade powder product, with a mean particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder supports the homogeneous mixing with other powder materials within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
    more
  • Polyglykol 4000 S*
    Polyglykol 4000 S is a flaked PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The flaked form enables easier handling of the material within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    more

Get In contact

Page summary

Summarization in progress