1. Home
  2. Cellulose ethers
  3. Croscarmellose Sodium

Croscarmellose Sodium

01 Overview

Crosslinked sodium carboxymethyl cellulose, also known as Ac-Di-Sol, is the hydrolyzed product of CMC. It contains approximately 70% carboxylate sodium salts, giving it significant hygroscopicity. However, due to the presence of crosslinks, it is insoluble in water. When exposed to water, it absorbs several times its own weight in water and swells, exhibiting excellent disintegration properties and compressibility.

Croscarmellose sodium is a white, fine granular powder that is odorless and tasteless. It exhibits hygroscopic properties with high water absorption and swelling capacity, and can form suspensions with slight viscosity. It is insoluble in organic solvents such as ethanol and diethyl ether. While generally stable, it undergoes oxidation and hydrolysis when exposed to strong oxidizing agents, strong acids, or strong bases.

Applications
Upon contact with water, this product rapidly swells due to its swelling capacity, delivering excellent disintegration performance. As a cellulose-based super disintegrant, it facilitates rapid disintegration and dissolution. Primarily used as a disintegrant in pharmaceutical formulations, it exhibits good compressibility and strong disintegration properties, making it suitable for all tableting processes.

Appearance White，free-flowing
Identification To meet requirement
B.  To meet requirement
C.  To meet requirement
PH 5.0~7.0
Settling volume 10.0~30.0 ml
Degree of substitution 0.60~0.85
Sodium chloride and sodium glycolate ≤ 0.5%
Content of water-soluble material ≤ 10.0%
Loss on Drying ≤ 10.0%
Residue on Ignition 14.0~28.0%
Heavy Metals ≤10ppm
Total aerobic microbial count ≤1000 CFU/gm
Total molds and yeasts ≤100 CFU/gm
Escherichia coli Absent
The product conforms to above test of current USP/NF/EP.

02 Tablet Disintegration

Croscarmellose sodium is an odorless, white, or off-white powder. Stable in nature but hygroscopic. Insoluble in water but rapidly expands its volume to 4-8 times upon contact with water. As a disintegrant in tablets, capsules, and granules, it is usually considered a non-toxic and non-irritating excipient.

03 Safety

Crosslinked sodium carboxymethylcellulose is primarily used as a disintegrant in oral formulations and is generally considered non-toxic and non-irritating. Large oral doses may have a laxative effect, but the quantities used in solid dosage formulations are unlikely to cause this issue. In the UK, crosslinked sodium carboxymethylcellulose is permitted for use in nutritional supplements. Since the essential dosage required for its active substance, sodium carboxymethylcellulose, to be effective is insufficient to pose a health risk, the WHO has not established an acceptable daily intake for it as a food additive. Crosslinked sodium carboxymethylcellulose is irritating to the eyes; protective measures should be taken for eye contact.

drum hpmc
Health Plans Sue

04 Example Recipe

  1. Direct compression tablet formula

Main medicine 4-5%, instant sorbitol 30-80%, microcrystalline cellulose 5-10%, croscarmellose sodium 3-7%, magnesium stearate 1%.

Most medicines can be directly compressed into tablets of good quality by using this excipient prescription.

  1. Ibuprofen Dispersible Tablets

The primary medicine is added with 5% croscarmellose sodium, 5% povidone K30, and 15% microcrystalline cellulose. The disintegrating agent adopts an internal addition method, and the prescription makes tablets of good quality.

05 Related Products