Frequently Asked Questions
Pharmgenity Health supplies Sodium Starch Glycolate, a highly effective superdisintegrant excipient used in oral solid dosage forms including tablets and capsules. Sodium Starch Glycolate is a modified sodium carboxymethylated starch that rapidly absorbs water and swells up to 300 times its volume, promoting rapid tablet disintegration and drug release. It is one of the most widely used superdisintegrants in the pharmaceutical industry, effective at low concentrations (2-8%) and compatible with both direct compression and wet granulation manufacturing processes.
Sodium Starch Glycolate acts primarily through a swelling mechanism. When the tablet comes into contact with aqueous fluids in the gastrointestinal tract, Sodium Starch Glycolate particles rapidly absorb water and swell to many times their original volume. This swelling exerts internal pressure within the tablet matrix, causing the tablet to rupture and disintegrate into smaller particles. This rapid disintegration increases the surface area available for drug dissolution and subsequent absorption, leading to improved bioavailability, especially for poorly soluble drugs.
Critical quality specifications for Sodium Starch Glycolate include particle size distribution (affecting blend uniformity and swelling performance), degree of substitution (determining swelling capacity and viscosity), pH of 1% aqueous dispersion (typically 5.5-7.5), loss on drying (NMT 10%), sodium content, sedimentation volume (a measure of swelling capacity), microbial limits per USP <61> and <62>, and heavy metals content. Our Sodium Starch Glycolate meets USP-NF, EP, and JP pharmacopeial standards and is accompanied by a certificate of analysis.
Yes, we can supply Sodium Starch Glycolate in different grades tailored to specific formulation requirements including variations in particle size, degree of substitution, and swelling capacity. For direct compression tablet formulations, we provide grades with optimized flow properties and particle size distribution (typically D50 of 30-60 microns). For wet granulation processes, we offer grades that maintain their disintegrant functionality after exposure to granulating fluids and drying. We work with customers to select the optimal grade based on their specific formulation, equipment, and manufacturing process.
For Sodium Starch Glycolate, we provide comprehensive regulatory documentation including certificates of analysis conforming to USP, EP, and JP pharmacopeial standards, material safety data sheets (MSDS), GMP certificates of compliance, stability data supporting retest periods, residual solvent analysis, elemental impurities data per ICH Q3D, microbial test reports, particle size distribution analysis, non-GMO and allergen statements, and BSE/TSE-free certificates. All documentation is provided in electronic format to support excipient registration in drug product filings.