Product Description

Ac-Di-Sol is FMC BioPolymer's trademark for an internally cross-linked form of sodium carboxymethylcellulose (NaCMC). Ac-Di-Sol differs from soluble sodium carboxymethylcellulose only in that it has been cross-linked to ensure that the product is essentially water insoluble. It is an odorless, relatively free flowing, white powder.

Typical Properties of Ac-Di-Sol
Typical Average Particle Size	NMT 2% 200 mesh NMT 10% 325 mesh
pH	5.9 - 7.0*
Degree of Substitution	0.63 - 0.85*
Settling Volume (ml)	10 - 30
Water Soluble Substances (%)	NMT 5.5*
Loss on Drying (%)	NMT 6.0
NMT = Not more than
* Tighter than Compendia

Applications

Ac-Di-Sol croscarmellose sodium aids in the disintegration and dissolution of pharmaceutical tablets, capsules, and granules. Originally created to solve formulators' problems with long-term stability, effectiveness at high tablet hardness levels, and the need for high use levels, Ac-Di-Sol is now the standard by which super disintegrants are judged.

Benefits

• good water uptake
• high capillary action
• rapid swelling properties
• efficient fluid channeling
• compatibility with most actives and excipients
• excellent long-term stability
• low usage level
• low cost-in-use
• global acceptance and availability

Detailed Product Information

The Chemistry of Ac-Di-SolBelow is a molecular model of the sodium carboxymethylcellulose (NaCMC) molecule, from which Ac-Di-Sol is manufactured.

Guidelines for Use in Tableting and Encapsulation

Tablets
Ac-Di-Sol is effective in both direct compression and wet granulation formulations. The amount of Ac-Di-Sol used in direct compression tableting may vary with typical usage levels between 1 and 3 percent. When added to granulations, generally the same percent is used as with a direct compression formulation. It is often added to both the wet mass and the dried granulations before compression. As with direct compression, the use level typically ranges from 1 to 3 percent with half of the material added to the wet mass and half added to the running powder. This promotes disintegration of both the granules and the tablet.

Capsules
The amount of Ac-Di-Sol used in capsule formulations generally ranges from 4 - 6 percent. Reduced interparticle contact within a capsule facilitates the need for elevated levels of disintegrant. Capsules filled on automatic dosater types of equipment, as opposed to semi-automatic or hand-filled machines, are more dense and have a harder structure due to the greater compressional forces needed to form the plug and successfully transfer it into the gelatin shell. Greater plug hardness results in greater effectiveness of Ac-Di-Sol.

Model Formulations Using Ac-Di-Sol
Ac-Di-Sol is functional in a variety of formulations. Please click here for example formulations using Ac-Di-Sol.

Regulatory Status of Ac-Di-Sol

Compendial Status of Ac-Di-Sol NaCMC and Common Name
Ac-Di-Sol complies with the following compendia and is referred to under the following common names:

Additional Regulatory Information and Toxicology
FMC BioPolymer maintains a self determined GRAS position for Ac-Di-Sol in dietary supplement tablets and capsules. The product is included in the FDA Inactive Ingredients Guide for oral capsules and tablets. It is also included in nonparenteral medicines licensed in the UK.

Comprehensive toxicological investigations have been performed on this product. A complete summary of these tests will be forwarded upon request.

Shelf Life/Storage Conditions
Ac-Di-Sol croscarmellose sodium is very stable and, therefore, has no need for an expiration date. The product is hygroscopic and can absorb ambient moisture if it is exposed to the atmosphere for an extended period of time. The product should be stored in a well sealed container.

Production Sites
FMC has two ISO 9002 registered manufacturing sites to serve our customers. Both our Newark, Delaware and Cork, Ireland facilities manufacture to the same high quality standards using the same cellulose sources. The manufacturing site of origin is clearly stated on the package and certificate of analysis.

Kosher Status
Ac-Di-Sol croscarmellose sodium is certified as Kosher. For certificates, please contact your nearest representative.

Product Brochure

For a copy of a product brochure, please click here.

MSDS

For a copy of the MSDS, please contact FMC BioPolymer.