PEG 3350 – Plasticizer in film-coated tablet

1. General Introduction to PEG 3350

PEG 3350 (Polyethylene Glycol 3350, or Macrogol 3350) is a nonionic polyether polymer with an average molecular weight of approximately 3,350 Da, produced through the polymerization of ethylene oxide. It is one of the most widely used pharmaceutical excipients due to its excellent safety profile, high water solubility, broad compatibility with APIs, and multifunctional performance in pharmaceutical formulations. PEG 3350 is recognized by the U.S. Food and Drug Administration (FDA) and is compliant with major pharmacopeial standards, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP), for use in a wide range of dosage forms.

Unlike low-molecular-weight PEGs (PEG 200–600), which are liquids at room temperature, PEG 3350 is a white solid available as granules or wax-like flakes. Its physical properties make it particularly suitable for use in tablets, capsules, ointments, suppositories, and a variety of advanced drug delivery systems.

In addition to its role as a pharmaceutical excipient, PEG 3350 is also widely used as an osmotic laxative active ingredient in medications for the treatment of constipation.

Manufactured using advanced synthesis and purification technologies, Biorich's PEG 3350 offers exceptional purity with stringent control of potentially harmful impurities. It delivers excellent batch-to-batch consistency and fully complies with the rigorous quality requirements of major international pharmacopeias, making it an ideal choice for the development and manufacture of high-quality pharmaceutical products.

2. Physicochemical Properties of PEG 3350

• Material Name: PEG 3350 / Polyethylene Glycol 3350 / Macrogol 3350
• Origin: India.
• Material Category: Active Pharmaceutical Ingredient (API) / Pharmaceutical Excipient.
• Function: Osmotic laxative (as an API), binder, plasticizer in film-coating tablet, consistency-modifying agent in topical formulations, solubility-enhancing excipient for poorly water-soluble APIs.
• Chemical Composition: A polymer of ethylene oxide and water, with an average molecular weight of 3350.
• Form: Powder or waxy flakes, white or almost white, odorless or with a very faint characteristic odor.
• Solubility: Very soluble in water, freely soluble in ethanol and polar organic solvents, insoluble in fatty ethers and mineral oils.
• Quality Standards: Complies with strict international pharmacopoeia standards such as USP, BP, and EP.

The material is strictly controlled for:

• Toxic Impurity Limits: Strict control of Ethylene Glycol and Diethylene Glycol (EG/DEG) levels to extremely low thresholds below international pharmacopeia limits, ensuring safety during use.
• Molecular Weight: Ensures a precise molecular weight at 3350 g/mol to maintain stable physicochemical properties and viscosity.
• Heavy Metals and Microbial Limits: Meets strict microbiological standards for both oral and topical preparations.

3. Key advantages of PEG 3350

• Widely used plasticizer: Enhances the flexibility of film coatings, minimizes the risk of cracking and peeling, improves the mechanical strength of film-coated tablets, and exhibits excellent compatibility with a wide range of film-forming polymers.
• Excellent water solubility: Due to its complete water solubility, PEG 3350 enhances the solubility of poorly water-soluble APIs and helps inhibit drug recrystallization, thereby improving dissolution performance.
• Suitable for advanced drug delivery systems:Widely used in solid dispersions, hot-melt processing technologies (including hot-melt granulation and hot-melt extrusion), and nanotechnology-based formulations to improve drug solubility and bioavailability.
• High purity and safety:Manufactured under stringent quality control with rigorous monitoring of organic impurities such as ethylene glycol (EG) and diethylene glycol (DEG), minimizing potential toxicity risks and ensuring compliance with global pharmacopeial standards.
• Excellent stability and compatibility:PEG 3350 exhibits high thermal stability, good chemical stability, and broad compatibility with most active pharmaceutical ingredients (APIs), making it suitable for a wide variety of pharmaceutical formulations.
• Cost-effective with a reliable supply: Manufactured in India, PEG 3350 offers a highly competitive cost compared with European sources while maintaining consistent quality, providing pharmaceutical manufacturers with a reliable and economical solution for optimizing production costs.

4. Applications of PEG 3350

In Pharmaceuticals

• Osmotic laxative (when used as an API): API for the treatment of acute and chronic constipation, as well as bowel cleansing prior to colonoscopy or colorectal surgery.
• Film-coated tablets: Plasticizer.
• Tablets and capsules: Binder.
• Suppositories and topical formulations:Base-forming excipient.
• Solubility enhancement of poorly water-soluble APIs in solid dosage forms.
• Solid dispersion systems and hot-melt processing technologies (including hot-melt granulation and hot-melt extrusion).
• Nano drug delivery formulations.

In Health Supplements and Cosmetics

• Healthcare Products: Applied in digestive support formulas.
• Cosmetics: Acts as a film-forming agent, humectant, and viscosity controller in creams and lotions.

5. Commercial Products Using PEG 3350

6. Product Contact Information

For more information about the supply chain, technical specifications of PEG 3350, or to place an order, please contact us:

• Consultation Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website:www.biorichgroup.com
• Sample/COA Request: Please contact us via email to request samples and the latest Certificate of Analysis (COA) for the material from the manufacturer.