Key Benefits & Why Formulators Choose NBE Sodium Starch Glycolate (SSG)
Superdisintegrant Performance:
SSG swells up to 300% of its original volume within seconds of water contact, delivering disintegration times far superior to conventional disintegrants.
Low Use Level Required:
Effective at 2–8% w/w — lower than many alternatives — reducing excipient costs and preserving tablet volume for active ingredients.
Works Across Tablet Manufacturing Methods:
Effective in direct compression, wet granulation, and dry granulation formulations.
pH-Independent Action:
SSG’s disintegration performance is effective across the pH range of the gastrointestinal tract.
Chemically Stable:
Low reactivity with APIs and other excipients, with good stability across temperature and humidity conditions.
Pharmacopoeial Compliance:
Meets USP, BP, and IP monograph specifications.
| Parameters | USP – NF |
|---|---|
| Identification A, B, C, D | Complies |
| pH | |
| Type A | 5.5 – 7.5 |
| Type B | 3.0 – 5.0 |
| Loss on Drying, % | NMT 10 |
| Heavy Metals, ppm | NMT 20 # |
| Sodium Chloride, % | NMT 7 |
| Sodium Glycolate % | NMT 2 |
| Assay % | |
| Type A | 2.8 – 4.2 |
| Type B | 2.0 – 3.4 |
| Swelling Volume ml* | |
| Limit of Iron % | NMT 0.002 |
| Microbiology Limits | |
| Escherichia Coli | Absent in 1g Sample |
| Salmonella Species | Absent in a 10g Sample |
| Type | Size |
|---|---|
| HDPE Bags | 25 Kg |
| HDPE Bags | 20 Kg |
| Paper Bags | 25 Kg |
| Paper Bags | 20 Kg |
| FIBC | 400 Kg |
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 12,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 24,000 Kg |
Frequently Asked Questions
How does Sodium Starch Glycolate work as a disintegrant?
Sodium Starch Glycolate works primarily through rapid water absorption and swelling. When a tablet comes into contact with gastrointestinal fluid, SSG particles absorb water and swell to up to 300% of their original volume very rapidly. This swelling creates intense internal mechanical pressure within the tablet matrix, forcing it to fragment and disintegrate quickly — releasing the active ingredient for faster dissolution and absorption.
What is the recommended concentration of SSG in tablet formulations?
Sodium Starch Glycolate is typically used at concentrations of 2% to 8% w/w. The optimal level depends on the tablet’s API load, compaction pressure, and desired disintegration time. Higher concentrations (above 8%) may actually reduce performance due to gel formation that inhibits water penetration.
Is Sodium Starch Glycolate compatible with all APIs?
SSG is generally compatible with most APIs. However, as it is a sodium salt, it should be evaluated carefully with APIs sensitive to electrolytes. Compatibility studies are always recommended as part of standard pre-formulation work.
