Name: Croscarmellose Sodium
Package: 5kg/bag, 25kg/drum
Appearance: White or off-white powder; hygroscopic. This product swells in water and
forms a suspension. It is insoluble in absolute ethanol, ether, acetone or toluene.
Quality Standard: CP2020, USP43-NF38, EP9.0
|CP2020; USP43-NF38; Ethanol NMT 0.01%||AG1302|
This product is usually used as a disintegrating agent for capsules, tablets and granules.
Its water-swelling capacity is better than that of low-substituted sodium carboxymethyl cellulose and microcrystalline cellulose, and has better disintegrating effect.
In tablets, this product is suitable for direct tableting and wet granulation.
In wet granulation, internal and external processes can be used to better display the disintegration effect.
Generally the concentration of it is up to 5% (W/W) used as a disintegrating agent, the usual amount of direct tableting is about 2% (W/W), the usual amount of wet granulation is about 3% (W/W).
For hydrophobic auxiliary (such as calcium phosphate) compressed tablets, the
disintegration effect is better, the minimum 0.5% (W/W) can exert the disintegration effect.
However, when methyl cellulose is as a binder, it will prolong the disintegration time of this product. The greater the viscosity of methyl cellulose, the longer the extension time.
In addition, this product can be used for swelling materials of pulse preparations, solid dispersion carriers, gastrointestinal dwelling bioadhesive drug release systems, etc.
|Highly effective disintegrants, commonly used in dispersible tablets||Finasteride Dispersible Tablets|
|Swelling materials, for pulse tablets||Triazolam Pulse Tablets|
|Others such as solid dispersion carriers, etc|
Whether in the wet granulation process or the direct tableting process, if there are other hygroscopic excipients in the prescription, the disintegration effect can be slightly reduced.
Combining with methyl cellulose will prolong the disintegration time, and corn starch will inhibit the disintegration effect.
Croscarmellose sodium is incompatible with soluble salts of strong acids, iron, or other metals (such as aluminum, mercury, zinc).
Safety: Croscarmellose sodium is generally considered non-toxic and non-irritating. It has a laxative effect when taken in large amounts orally, but it usually does not cause this problem when used in solid preparations.
Storage: This product has strong hygroscopicity. It should be stored in a sealed, cool and dry place.