This product is a sodium salt of starch acrylamide, which is formed under alkaline conditions by the reaction of starch with acrylic acid. It appears as a white or off-white powder, odorless, with hygroscopic properties; it disperses in water to form a viscous colloidal solution, and is insoluble in ethanol or acetone.
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Sodium Starch Glycolate (SSG) EP10.0, derived specifically from potato starch, is a highly effective superdisintegrant widely utilized in the pharmaceutical industry for tablet formulation. Its primary function is to facilitate the rapid disintegration of compressed tablets upon contact with gastrointestinal fluids, ensuring efficient drug release and bioavailability. The chemical structure involves sodium salts of cross-linked starches, where the etherification process introduces hydrophilic carboxymethyl groups that enhance water absorption capabilities significantly compared to native starch.
The specific CAS number for Sodium Starch Glycolate is 9004-38-2. This compound adheres strictly to the European Pharmacopoeia (EP) 10.0 monograph standards, guaranteeing high purity, consistent particle size distribution, and reliable performance across various manufacturing processes. As a potato-derived product, it offers distinct advantages over corn or tapioca variants, including superior swelling power and compressibility, which are critical for maintaining tablet integrity during handling while ensuring immediate breakup in the stomach.
In practical applications, SSG is typically added at concentrations ranging from 1% to 5% by weight in direct compression and wet granulation methods. It acts through two main mechanisms: capillary action, where water penetrates the tablet matrix rapidly, and swelling, where the polymer expands to break the cohesive forces holding the tablet together. This dual-action ensures that even hard tablets disintegrate within minutes, a crucial factor for drugs requiring quick onset of action. Furthermore, its compatibility with a broad spectrum of active pharmaceutical ingredients (APIs) makes it a versatile excipient suitable for both immediate-release and modified-release formulations. Regulatory bodies globally recognize SSG as safe for human consumption, and its non-toxic nature supports its use in diverse dosage forms including effervescent tablets and orally disintegrating tablets. Due to its excellent flow properties and minimal impact on tablet hardness, Sodium Starch Glycolate remains a cornerstone ingredient in modern solid dosage development, bridging the gap between robust manufacturing requirements and optimal therapeutic efficacy.