Carboxymethylcellulose Calcium

CMC-Ca Carmellose Calcium

Carmellose Calcium

CMC Carmellose

In Japan, ECG-505 has received the most favorable evaluation. Carboxymethylcellulose Calcium (ECG-505) and Carmellose Calcium (NS-300) have been produced under strict quality control, and have been widely used as agents for disintegration and dispersion of tablets and granules. This dispersion is one of the requirements for attaining the higher bioavailability of a drug. ECG-505 was published in JP in 1966. ECG-505 was published in USP-XXI, US-NF X VI in 1985 and in EP in 1994. NS-300 was also published in JP in 1986. In 1992, ECG-505 was chosen among the 25 most frequently used pharmaceutical excipients in International Harmonization Monographs and NS-300 was also chosen as an addendum item to those of ECG-505.

Product Description
Characteristics of ECG®-505 and NS-300®

ECG-505 and NS-300 are made up of cellulose modified by carboxymethylation.
ECG-505 is the only disintegrant, among many disintegrants in the world, containing calcium as a component.
NS-300 is produced by lowering Carboxymethylcellulose Sodium's pH by an acid treatment.
ECG-505 and NS-300 rapidly absorb the water needed for swelling and consequently show a very short disintegration time.
The process of dispersion to powder caused by the disintegration of tablets and granules is very important for promoting the solubility and thereby the bioavailability of drugs.
ECG-505 is insoluble but shows hydrophilic property in water due to its chemlate structure and calcium component. NS-300 of carboxylic acid type shows poor hydration but shows a sufficient disintegration function by its electrostatic repulsive force.
Although in practice ECG-505 has been used favorably more than has NS-300 for pharmaceutical formations, one drawback is that the calcium component interacts with some medicines which contain phosphate or sulfate. In these cases, NS-300 is used instead of ECG-505.

Advantages of ECG-505 and NS-300
1. Rapid Disintegration
ECG-505 and NS-300 are superior to starch in their disintegration abilities. ECG-505 has a higher ability to absorb water due to its chelate structure and calcium component.
2. Release and Dissolution
Higher drug release and dissolution properties are very important for promoting the bioavailability of tablets and granules. ECG-505 and NS-300 rapidly disintegrate tablets and granules, although they are insoluble in water.
3. Compressibility
Because of their fibrous shape, ECG-505 and NS-300 have a high compressibility as well as high disintegration properties. Tablets and granules formulated with ECG-505 and NS-300 show both a very short disintegration time and high mechanical strength based on their high compressibility.
4. Stability
ECG-505 and NS-300 show high long-term stability in various tablet and granule prescriptions. However, owing to its calcium, ECG-505 may interact with some substances containing phosphate and sulfate.
II. The Chemistry of ECG®-505 and NS-300®.
ECG-505 is composed of the calcium salts Carboxymethylcellulose, while NS-300 is the free form of Carboxymethylcellulose, a cellulose derivative formed by etherification with monochloroacetic acid under the alkali catalyst.
Both products are, odorless, harmless fine powders.
Both are practically insoluble in ethanol and ether. They absorb and swell with water to form suspension.
The chemical structure formula of ECG-505 is shown in Fig-1-A; that of NS-300 is shown in Fig-1-B.
Properties
  ECG-505 NS-300
Degree of Substitution 0.5-0.7/C6 0.4-0.6/C6
Particle Through 300mesh more than 95% more than 95%
Bulk Density 500-600gle 300-400gle
Solubility: Distilled Water
0.1N NaOH
Insoluble
Swellable
Gelation
Insoluble
Swellable
Gelation
pH 4.5-6.0 3.5-5.0
Stability: Sunlight Stable Stable
Humidity see Fig-2 see Fig-3