PEG 400 is widely used in pharmaceutical formulations as a solvent and co-solvent to enhance the solubility of poorly soluble APIs in liquid and semi-solid dosage forms.
PEG 400 (Polyethylene Glycol 400 or Macrogol 400) is an ethylene oxide polymer widely used in the pharmaceutical and cosmetic industries. Unlike high-molecular-weight PEGs that exist in solid forms, PEG 400 is a clear, viscous liquid. It serves as a highly effective solvent, co-solvent, and bioavailability enhancer for active pharmaceutical ingredients (APIs) that are poorly soluble in water. In particular, PEG 400 is an indispensable component in the formulation of soft gelatin capsules (softgels) and oral liquid dosage forms.
The raw material is manufactured by Nitika Pharmaceutical Specialities Pvt. Ltd. (India), one of the leading and most reputable excipient manufacturers in India. Utilizing modern production lines and strict quality management systems, Nitika's PEG 400 achieves optimal purity and complies with international pharmacopoeia standards, ensuring high safety, stability, and excellent compatibility in all formulations.
Function: Solvent, co-solvent for solubility enhancement, humectant, softgel capsule vehicle, and carrier for topical formulations.
Chemical Composition: A polymer of ethylene oxide and water, with an average molecular weight of approximately 400.
Form: Slightly viscous, clear, colorless or almost colorless liquid. It is hygroscopic (absorbs moisture).
Solubility: Completely soluble in water, ethanol, acetone, and other glycols; 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:
Molecular Weight: Ensures a standard molecular weight distribution ranging from 380 to 420.
Purity and Safety: Strict control of related impurities, free ethylene oxide, 1,4-dioxane, and heavy metal limits, ensuring absolute safety.
Stability Indicators: Strict monitoring of pH and moisture levels to prevent any adverse impact on the stability of the active ingredients (APIs) when formulated together.
3. Key advantages of Nitika's PEG 400
Outstanding Solubilizing Capacity: PEG 400 is a widely used solvent capable of dissolving a broad range of poorly water-soluble active pharmaceutical ingredients (APIs). It helps prevent API recrystallization, thereby significantly improving dissolution, enhancing drug absorption, and increasing bioavailability.
Low Viscosity: PEG 400 has a low viscosity, making it easy to handle, mix, and process during pharmaceutical manufacturing.
Excellent Compatibility with Soft Gelatin Capsules:PEG 400 is commonly used as a solubilizer for poorly water-soluble APIs in soft gelatin capsule fill formulations. It is compatible with gelatin shells and does not adversely affect capsule integrity, helping prevent brittleness or cracking during long-term storage.
Suitable for Advanced Drug Delivery Systems: PEG 400 is widely used as a component of self-emulsifying drug delivery systems (SEDDS/SMEDDS) and is also incorporated into various dispersion-based formulations to improve the solubility and oral bioavailability of poorly soluble drugs.
High Biocompatibility and Safety Profile: PEG 400 exhibits very low toxicity and minimal irritation to the skin and mucous membranes. It is well tolerated in oral, topical, and certain parenteral formulations, while offering excellent compatibility with a wide range of APIs and pharmaceutical excipients.
International Quality Standards:Manufactured in GMP-compliant facilities, PEG 400 delivers consistent purity and quality, meeting the stringent requirements of global pharmaceutical manufacturing standards.
4. Applications of PEG 400
In Pharmaceuticals
Soft Gelatin Capsules (Softgels): Serves as a solvent/co-solvent to dissolve poorly water-soluble APIs in softgel fill formulations.
Liquid Dosage Forms (Injectables, Ophthalmic Solutions, and Oral Liquids): Functions as a co-solvent to enhance API solubility, improve dispersion, and maintain formulation stability.
Topical Formulations: Acts as a solubilizing excipient in ointments, creams, and gels, providing moisturizing properties, improving spreadability, and facilitating drug release.
Suppositories:Used in combination with PEG 4000 or PEG 6000 to produce suppository bases with improved flexibility, reduced brittleness, and enhanced ease of administration.
Self-Emulsifying and Solid Dispersion Systems
In Health Supplements and Cosmetics
Healthcare Products: Used as a carrier in softgel capsules containing vitamins and herbal extracts.
Cosmetics: Acts as a humectant, solvent, and viscosity modifier in lotions, body washes, and toothpaste.
5. Commercial Products Using PEG 400
6. Product Contact Information
For more information about the supply chain, technical specifications of PEG 400, or to place an order, please contact us:
Sample/COA Request: Please contact us via email to request samples and the latest Certificate of Analysis (COA) for the material from the manufacturer.
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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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