Preface
Disintegrants are substances that can cause tablets to rapidly break down into fine particles in gastric fluid, thereby enabling the active ingredients to dissolve and be absorbed quickly, and exert their effects. Most of these substances have good water absorption and expansion properties, enabling the tablets to disintegrate. Except for sustained (controlled) release tablets and certain special-purpose tablets, disintegrants should be added to most tablets.
SallysoTM交联羧甲基纤维素钠（Croscarmellose Sodium）
Croscarmellose Sodium is a cross-linked polymer of Sodium Carboxymethyl Cellulose. It is used as a disintegrant in oral dosage forms, such as capsules, tablets, and granules. In tablets, Croscarmellose Sodium is applicable to direct compression and wet granulation compression processes. During wet granulation, Croscarmellose Sodium can be added either during the wetting stage or the drying stage (either inside or outside the particles), which can best utilize the capillary and swelling properties of the disintegrant. When used as a disintegrant, the concentration of Croscarmellose Sodium can reach 5% (W/W), but in the direct compression process, the dosage is typically 2% (W/W), and in wet granulation compression, it is 3% (W/W).
Particle size
Electron micrographs
1 Prescription example using Sallyso™
Metformin Tablets (Direct Compression)
The Gangwal product (SallysoTM) has comparable or superior hardness, compressibility and disintegration performance to those of the competing products.
The Gangwal product (SallysoTM) has comparable or superior hardness, compressibility and disintegration performance to those of the competing products.
Given the well-known fact that calcium phosphate tablets have poor disintegration properties, we compared different levels of cross-linked carboxymethyl cellulose sodium and its effect on the disintegration time of calcium phosphate tablets.
Sodium Starch Glycolate
（Sodium Starch Glycolate）
Sodium Starch Glycolate is a white amorphous powder with hygroscopic properties. It disperses into a viscous colloidal solution in water and is insoluble in ethanol or ether. Its bulk density is 0.66g/ml and the tapped density is 0.83g/ml. This product is generally spherical in shape, thus having excellent fluidity.
Electron micrographs
1 Prescription example using Solvostar (SSG)
Diclofenac Tablets
Results：
At a 1% SSG level, the disintegration performance of Gangwal’s product (Solvostar) was superior to that of the competing products; at 2% and 4% levels, the disintegration capabilities were comparable.
At the 1% and 2% levels, the disintegration ability was comparable; at the 4% level, the disintegration performance of Gangwal’s product (Solvostar) was superior to that of the competing products.
At the 1% and 2% levels, the disintegration ability was comparable; at the 4% level, the disintegration performance of Gangwal’s product (Solvostar) was superior to that of the competing products.
Product Comparison – Croscarmellose Sodium VS Sodium Starch Glycolate
Disintegration Characteristics Comparison
Disintegration ability
The water absorption lag time reflects the initial situation of water penetrating into the tablet. Generally, the shorter the water absorption lag time and the greater the water absorption rate, the faster the tablet disintegrates. For SSG although its water absorption lag time is long and the water absorption rate is low, its characteristic of rapid expansion upon contact with water is sufficient to overcome the adhesion between particles. Therefore, its disintegration effect after being used in tablets is still very good.
Drug compatibility contraindications and safety
CDE：
F20230000371
F20240000310
