Avicel RC-591, RC-581 and CL-611 microcrystalline cellulose and carboxymethycellulose sodium, NF are water insoluble dispersible colloidal excipients used in the preparation of pharmaceutical suspensions and emulsions. These products provide a structured dispersion vehicle exhibiting a high degree of thixotropy, yielding superior suspension stability in a formulation. The primary differences between the types of colloidal Avicel are end product viscosity/gel strength and methods of dispersion required for complete activation. These differences yield a wide selection of alternatives in wet suspensions, dry suspensions, and creams and emulsions. The high functionality of Avicel RC/CL products relates primarily to the unique rheology characteristics. Avicel dispersions yield a highly thixotropic vehicle, which is primarily the result of the large number of colloidal microcrystal particles that result from full dispersion in aqueous media. The network establishes a weak gel structure with a measurable yield point that prevents drug particles from settling in a formulation. This gel structure is easily broken by mild shaking to yield an elegant, readily pourable liquid. Upon removal of shear, the gel structure re-establishes, providing a suspension medium with long-term stability against phase separation.

Applications

Numerous marketed drug products rely on the performance of Avicel RC/CL in the formulation. Several case history and formulation examples illustrate the broad utility of these products. Actual formulation details and performance will vary depending on types of drug and excipients used in the formulation.

Benefits

• Viscosity regulator and modifier
• Thixotropic characteristics
• Heat and free-thaw stable
• Long shelf-life stability
• Lengthy hydration times eliminated
• Stable at pH range 4-11
• Odorless, tasteless

Detailed Product Information

Regulatory Status of Avicel RC/CL
Avicel RC/CL colloid-forming, attrited mixtures of microcrystalline cellulose and sodium arboxymethylcellulose meet the standards set forth in the United States Pharmacopeia/National Formulary for microcrystalline cellulose and carboxymethylcellulose sodium and in the British Pharmacopoeia for dispersable cellulose. Microcrystalline cellulose and sodium carboxymethylcellulose are generally recognized as safe (GRAS) by qualified experts and are in accordance with the United States Food and Drug Regulations. Avicel RC/CL products are manufactured in accordance with current Good Manufacturing Practices and are in compliance with the Federal Food, Drug and Cosmetic Act, as Amended

Shelf Life/Stability for Avicel® RC/CL
Store in cool, dry place and avoid exposure to excessive heat.This product is hygroscopic and should not be exposed to moisture. It should maintain functional properties for at least two years. Product release specifications are guaranteed at the time of purchase.

Production Sites
FMC has two ISO 9002 registered manufacturing sites to serve our customers. Both our 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
Avicel RC/CL is certified as Kosher. For certificates, please contact your nearest representative.

Product Brochure

For a copy of the Avicel® RC/CL product brochure, please click here .

For a copy of the Avicel® RC-591 product brochure, please click here .

Concept Bulletin

For a copy of a concept bulletin, please click here.

MSDS

For the MSDS, please click here.

Dispersion of Avicel RC/CL

Proper, complete dispersion and activation of Avicel RC/CL products is crucial to realize the full performance benefits in a suspension formulation. Upon dispersion, a structured vehicle is established. Continuing with the formulation so as not to disrupt or destroy the structured vehicle can be accomplished by careful attention to the order of addition procedures.

The steps necessary to properly disperse each grade of Avicel are described below. Bulk Dried Avicel Colloidal. This procedure pertains to Avicel RC-581 which requires homogenization for dispersion.

Procedure

• Add Avicel to water while agitating.
• Add protective colloids (if required).
• Agitate 10-15 minutes.
• Add other ingredients.
• Hold the salts and acids until last.
• Homogenize at 200 psi.

Spray Dried Avicel Colloidal
This procedure pertains to Avicel microcrystalline cellulose types RC-591 and CL-611 which require rapid agitation in water for dispersion.

Procedure
Option I: High-speed mixer

• Add Avicel to the water while agitating.
• Follow with a protective colloid if the pH of your system is less than 4.
• Agitate with high velocity agitator fo 10-15 minutes.
• Add the other ingredients.
• Hold the salts and acids until last.

Option II: Funnel with blender pump

• Using only the water portion of the batch, activate Avicel using an ingredient funnel with a pump.
• Continue pumping for 10-15 minutes following the addition of Avicel.

Option III: High-speed blending tank

• Using only the water portion of the batch, activate the Avicel product by utilizing a liquifier type dispersion tank.
• Mix for 3 minutes.