Description

Polydextrose FCC

Polydextrose FCC is a high-purity, water-soluble polysaccharide used in pharmaceutical, nutraceutical, and food applications as a bulking agent, prebiotic fiber, and controlled-release excipient. It provides soluble fiber functionality, enhances tablet and capsule formulations, and supports digestive health, all while maintaining low caloric impact. Polydextrose

• Is a Food Chemicals Codex (FCC) compliant soluble polymer
• Is used as a bulking agent, fiber supplement, and excipient in tablets and capsules
• Supports prebiotic activity and promotes gut health
• Is suitable for oral dosage forms, chewable tablets, and powder blends
• Is manufactured under Good Manufacturing Practice (GMP) conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis (CoA) and technical data

Polydextrose is produced by polymerization of Dextrose in the presence of Sorbitol and organic acids, forming a highly branched Glucose polymer. It is partially fermentable in the colon, providing prebiotic benefits and promoting the growth of beneficial gut microbiota.

In pharmaceutical and nutraceutical applications, Polydextrose FCC is used in:

• Tablets and capsules as a low-calorie bulking and binder agent
• Chewable and effervescent formulations for fiber fortification
• Powder blends for oral nutrition supplements
• Prebiotic formulations to support digestive health and intestinal flora
• Controlled-release matrix systems for drug delivery

Polydextrose offers excellent compressibility and flow properties, making it suitable for direct compression tableting and uniform blending with other excipients. Its prebiotic activity contributes to gut health, while its low sweetness and neutral taste allow for versatile formulation in various dosage forms.

CarboMer supplies Polydextrose FCC with validated control over molecular weight distribution, moisture content, pH, and microbial quality. The material meets FCC standards and is suitable for human consumption in regulated dietary and pharmaceutical products.

The material is packaged in sealed, moisture-protective, tamper-evident containers. Available in laboratory, pilot, and commercial volumes. Minimum order quantities (MOQ), lead times, and documentation, including CoA and SDS, are provided upon request.

Each batch is tested for identity (IR, HPLC), moisture content, pH, particle size, microbial limits, and heavy metals. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer functional excipients and specialty polymers, Polydextrose FCC is supported by formulation expertise, regulatory guidance, and secure supply to support the development of safe, effective, and compliant pharmaceutical, nutraceutical, and food products.