PEG 6000 is a versatile pharmaceutical excipient widely used in drug formulation. It serves multiple functions, including as a lubricant for effervescent tablets, a plasticizer in film coating formulations, and a base material for suppositories and topical dosage forms.
PEG 6000 (Polyethylene Glycol 6000, also known as Macrogol 6000) is a nonionic polyether polymer with an average molecular weight of approximately 6,000 Da, synthesized 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 roles in pharmaceutical formulations. PEG 6000 is recognized by the U.S. Food and Drug Administration (FDA) and major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP), for use in a wide range of pharmaceutical dosage forms.
Unlike lower molecular weight PEGs (PEG 200–600), which are liquids at room temperature, PEG 6000 is a white solid available in granular or wax-like flake form. Its physical properties make it particularly suitable for tablets, hard capsules, ointments, suppositories, and various advanced drug delivery systems.
Manufactured using advanced synthesis and purification technologies, Biorich's PEG 6000 offers exceptional purity with stringent control of potentially harmful impurities. It ensures outstanding batch-to-batch consistency while fully complying with the rigorous quality requirements of major international pharmacopoeias, making it an ideal choice for high-quality pharmaceutical formulations.
2. Physicochemical properties of PEG 6000
Material Name: PEG 6000 / Polyethylene Glycol 6000 (Macrogol 6000)
Origin: India
Category: Pharmaceutical Excipients
Function: Lubricant for effervescent tablets, Plasticizer for film coating formulations, Base material for suppositories and topical formulations, Solubility-enhancing agent
Chemical Composition: Polymer of ethylene oxide and water, general formula H(OCH2CH2)nOH (with the average n corresponding to a molecular weight of approximately 6000).
Form: Flakes or fine white crystalline powder, solid, odorless or with a faint characteristic odor.
Solubility: Very soluble in water (forming a clear solution), freely soluble in ethanol and chloroform, practically insoluble in ether and fatty oils.
Quality Standards: Complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), or Indian Pharmacopoeia (IP) standards.
The raw 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 distribution from 5400 - 6600 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. Advantages of PEG 6000
Water-Soluble Lubricant: Unlike magnesium stearate, which is water-insoluble, PEG 6000 dissolves completely in water, making it an ideal lubricant for effervescent tablet formulations. It does not leave an oily film after dissolution, does not impart an unpleasant taste, and has minimal impact on the dissolution rate or bioavailability of the API.
Excellent Water Solubility:Owing to its complete water solubility, PEG 6000 enhances the dissolution of poorly water-soluble drugs by improving wettability and reducing drug crystallization, thereby promoting faster drug release.
Effective Plasticizer:PEG 6000 is widely used as a plasticizer in film coating formulations. It improves film flexibility, minimizes cracking and peeling, enhances the mechanical strength of coated tablets, and is compatible with a wide range of film-forming polymers.
Suitable for Advanced Drug Delivery Systems:PEG 6000 is extensively employed in solid dispersions, hot-melt processing technologies, and nanotechnology-based formulations to improve drug solubility and formulation performance.
High Purity and Safety:Manufactured under stringent quality control, PEG 6000 undergoes rigorous monitoring of organic impurities, including ethylene glycol (EG) and diethylene glycol (DEG), ensuring a high-purity product with minimized toxicological risk.
Excellent Stability and Compatibility: PEG 6000 exhibits high thermal stability, excellent physicochemical stability, and broad compatibility with most APIs and pharmaceutical excipients, facilitating formulation development.
Cost-Effective with a Reliable Supply: Manufactured in India, PEG 6000 offers a competitive price advantage over comparable European products while maintaining high pharmaceutical quality. Its reliable supply chain makes it a cost-effective solution for pharmaceutical manufacturers seeking to optimize production costs without compromising product performance.
Film-Coated Tablets: Plasticizer for film coating formulations
Suppositories and Topical Formulations: Base material
Solid Dosage Forms: Solubility-enhancing agent for poorly water-soluble APIs
Solid Dispersions and Hot-Melt Processing:Carrier and solubility enhancer
Nano Drug Formulations:Excipient for advanced drug delivery systems
In Health Supplements
Vitamin effervescent products: Widely applied as a tableting excipient for effervescent tablets supplementing Vitamin C, Multivitamins, and electrolytes.
Solubilizer and dispersant: Helps increase solubility and improve the bioavailability of herbal extracts or poorly soluble active ingredients.
5. Commercial Products Using PEG 6000
6. Product Contact Information
For more information on the supply chain, PEG 6000 technical specifications, or to place an order, please contact us:
Sample/COA Request: Please contact us via email to request a sample and the latest Certificate of Analysis (COA) of the raw material from the manufacturer, Nitika Pharmaceutical Specialities Pvt. Ltd.
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Biorich Group
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Biorich Group provides raw materials and supply chain solutions for the pharmaceutical, nutrition, healthcare, cosmetics, food, and industrial sectors, with a global network of partners.
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