Frequently Asked Questions
Pharmgenity Health supplies pharmaceutical-grade superdisintegrant excipients including Cross Carmellose Sodium (a cross-linked cellulose derivative that provides rapid disintegration), Sodium Starch Glycolate (a modified starch with excellent water absorption and swelling properties), and Cross Povidone XL 10 (a cross-linked polyvinylpyrrolidone with high capillary activity). These superdisintegrants are essential components in tablet and capsule formulations that promote rapid breakup and drug release for enhanced bioavailability.
Cross Carmellose Sodium is a cross-linked sodium carboxymethylcellulose that swells rapidly in aqueous media through wicking and swelling mechanisms, providing fast tablet disintegration typically within 15-30 seconds. Sodium Starch Glycolate is a modified carboxymethylated starch that absorbs water and swells up to 300 times its volume, making it one of the most effective superdisintegrants at low concentrations (2-8%). Cross Carmellose Sodium is preferred for formulations requiring rapid disintegration with minimal effect on tablet hardness, while Sodium Starch Glycolate offers superior swelling capacity particularly beneficial for high-dose drug formulations.
Critical quality specifications for superdisintegrant excipients include particle size distribution (affecting blend uniformity and disintegration rate), degree of cross-linking (determining swelling capacity), swelling index (measured as volume increase upon hydration), pH of aqueous dispersion (important for drug compatibility), loss on drying (typically NMT 10% for optimal performance), microbial limits per USP <61> and <62>, heavy metals content, and identification by IR spectroscopy. All our excipients meet applicable USP-NF, EP, or JP pharmacopeial standards and are accompanied by certificates of analysis.
Yes, our superdisintegrant excipients including Cross Carmellose Sodium, Sodium Starch Glycolate, and Cross Povidone XL 10 are designed for use in direct compression tableting processes. They have excellent flow properties and blending characteristics that enable uniform distribution in powder blends. These excipients are compatible with both direct compression and wet granulation processes and can be used in concentrations ranging from 2-10% depending on the formulation requirements. We provide technical data on compressibility, flowability, and compatibility with commonly used active pharmaceutical ingredients.
For our pharmaceutical excipients, we provide comprehensive regulatory documentation including certificates of analysis conforming to applicable pharmacopeial standards, material safety data sheets (MSDS), GMP certificates of compliance, stability data supporting retest periods, residual solvent analysis per ICH Q3C, elemental impurities data per ICH Q3D, microbial test reports, particle size distribution reports, non-GMO and allergen statements, and BSE/TSE-free certificates. This documentation supports excipient registration in drug product filings globally.