Sodium Starch Glycolate-Based Coated Pellets are pharmaceutical excipient-based multiparticulate pellets formulated using sodium starch glycolate as a principal excipient component and subsequently processed with a suitable coating system. Sodium starch glycolate is the sodium salt of a cross-linked, partly O-carboxymethylated starch and is recognized as a pharmaceutical excipient. It is identified by CAS 9063-38-1.
Sodium starch glycolate is available in different pharmacopoeial types. Type A contains 2.8–4.2% sodium, while Type B contains 2.0–3.4% sodium, calculated on the specified dried, ethanol-washed material. The corresponding pH ranges are 5.5–7.5 for Type A and 3.0–5.0 for Type B.
The pelletized format provides a multiparticulate platform that can be further processed with a functional or protective coating. The coating material, coating weight gain, coating thickness, particle-size distribution and finished-pellet performance are formulation-specific and should be established in the applicable product specification.
Sodium starch glycolate is hygroscopic and practically insoluble in dichloromethane, while producing a translucent suspension in water.
Sodium Starch Glycolate-Based Coated Pellets can be considered for:
The final properties of these coated pellets depend on the sodium starch glycolate grade, botanical source, pellet composition, pelletization process, coating material and coating level.
For the underlying excipient, pharmacopoeial references specify loss on drying NMT 10.0%, with Type A and Type B pH and sodium-content ranges as described above.
A finished coated-pellet specification should separately control parameters such as:
These parameters should not be assigned numerical values without the actual SDP product specification.
Sodium Starch Glycolate-Based Coated Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, sodium starch glycolate loading, coating system, coating weight gain, moisture specification and packaging configuration should be confirmed against the applicable product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 10.0% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 10.0% |