Sodium Starch Glycolate-Containing Pellets are pharmaceutical excipient-based multiparticulate pellets in which sodium starch glycolate is incorporated as one component of the pellet formulation. Unlike a pure sodium starch glycolate pellet, the term “containing pellets” indicates that the finished pellet can contain sodium starch glycolate together with other excipients or formulation components.
Sodium starch glycolate is the sodium salt of a carboxymethyl ether of starch or a cross-linked carboxymethyl ether of starch. It is identified by CAS 9063-38-1 and is used as a pharmaceutical excipient. USP-NF recognizes Type A and Type B grades with different pH and sodium-content ranges.
For the underlying excipient, Type A has a pharmacopoeial pH range of 5.5–7.5 and combined sodium content of 2.8–4.2%, while Type B has a pH range of 3.0–5.0 and sodium content of 2.0–3.4%. Loss on drying is NMT 10.0%.
Because this product is described as Sodium Starch Glycolate-Containing Pellets, the finished-pellet assay or loading should not be assumed to equal the assay of the raw excipient. The actual sodium starch glycolate percentage, pellet size, moisture, density and other finished-product characteristics are formulation-specific.
Sodium Starch Glycolate-Containing Pellets can be considered for:
The final properties depend on the percentage of sodium starch glycolate, other excipients, pelletization process, particle-size distribution and formulation design.
Sodium starch glycolate is hygroscopic and forms a translucent suspension in water. Pharmacopoeial specifications control parameters such as identification, pH, loss on drying, iron, sodium chloride, sodium glycolate and sodium content.
For a finished Sodium Starch Glycolate-Containing Pellet, parameters such as finished sodium starch glycolate loading, moisture, bulk density, tapped density, friability and pellet size should be established from the actual product specification rather than assumed from the raw-material monograph.
Sodium Starch Glycolate-Containing Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Sodium starch glycolate loading, pellet size, moisture, density, packaging configuration and finished-product acceptance criteria should be confirmed against the applicable SDP 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 0.1% |
| pH (1% Solution) | 5.5–7.5 |
| Water Content | NMT 10.0% |