Cellulose Microcrystalline and Carboxy methylcellu

Category

Dispersing Agents; Emulsion Stabilizer; Stabilizing Agents; Suspending Agents; Thickening Agents

Grade

Pharmceutical Excipients

Description

Microcrystalline cellulose and carboxymethylcellulose sodium occurs as a white or off-white odorless and tasteless hygroscopic powder containing 5-22% sodium carboxymethylcellulose. It is a water-dispersible organic hydrocolloid.

UNII

NA

Chemical Name

/

Synonyms

Avicel CL-611; Avicel RC-501; Avicel RC-581; Avicel RC-591; Avicel RC/CL; cellulosum microcristallinum et carmellosum natricum; colloidal cellulose; Vivapur MCG 591 PCG; Vivapur MCG 611 PCG

Administration route

Inhalations; ora; topical and vaginal

Dosage Form

Inhalations; oral capsules, powders, suspensions, syrups, and tablets; topical and vaginal preparations

Stability and Storage Conditions

Microcrystalline cellulose and carboxymethylcellulose sodium is hygroscopic and should not be exposed to moisture. It is stable over a pH range of 3.5-11. Store in a cool, dry place. Avoid exposure to excessive heat.

Source and Preparation

Microcrystalline cellulose and carboxymethylcellulose sodium is a spray- or bulk-dried blend of microcrystalline cellulose and sodium carboxymethylcellulose. It is prepared by the chemical depolymerization of highly purified wood pulp. The original crystalline areas of the pulp fibers are combined with sodium carboxymethylcellulose, which serves as a protective colloid and also facilitates dispersion of the product; it is then either spray- or bulk-dried.

Applications

Microcrystalline cellulose and carboxymethylcellulose sodium is used to produce thixotropic gels suitable as suspending vehicles in pharmaceutical and cosmetic formulations. The sodium carboxymethylcellulose aids dispersion and serves as a protective colloid. Concentrations of less than 1% solids produce fluid dispersions, while concentrations of more than 1.2% solids produce thixotropic gels. When properly dispersed, it imparts emulsion stability, opacity and suspension in a variety of products, and is used in nasal sprays, topical sprays and lotions, oral suspensions, emulsions, creams and gels.

Safety

Microcrystalline cellulose and carboxymethylcellulose sodium is used in a wide range of pharmaceutical formulations and has low oral, dermal and inhalation toxicity. It is nonirritating to the eyes and skin, and nonsensitizing to the skin. No significant acute toxicological effects are expected. LD50 (skin, rabbit): >2.0 g/kg LD50 (oral, rat): >5.0 g/kg

Incompatibilities

Microcrystalline cellulose and carboxymethylcellulose sodium is incompatible with strong oxidizing agents.