Health Care Active Pharmaceutical Ingredients:
Polyethylene Glycols

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

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.

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 society^{1, 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).