Cellulose, Powdered

Synonyms: Alpha-cellulose; Arbocel; cellulosi pulvis; E460; Elcema; KC Flock; Microcel 3E-150; Sanacel; Sanacel Pharma; Sancel-W; Solka-Floc.

Description: Powdered cellulose occurs as a white or almost white, odorless and tasteless powder of various particle sizes, ranging from a freeflowing fine or granular dense powder, to a coarse, fluffy, nonflowing material.

Chemical Name: Cellulose

Adsorbent; glidant; suspending agent; tablet and capsule diluent; tablet disintegrant; thickening agent.

• Powdered cellulose is used as a tablet diluent and filler in two-piece hard capsules. In both contexts it acts as a bulking agent to increase the physical size of the dosage form for formulations containing a small amount of active substance.

• Powdered cellulose has acceptable compression properties, although the flow properties of most brands are poor. However, low-crystallinity powdered cellulose has exhibited properties that are different from standard powdered cellulose materials, and has shown potential as a direct-compression excipient.

• In soft gelatin capsules, powdered cellulose may be used to reduce the sedimentation rate of oily suspension fills.

• It is also used as the powder base material of powder dosage forms, and as a suspending agent in aqueous suspensions for peroral delivery.

• It may also be used to reduce sedimentation during the manufacture of suppositories.

• Powdered cellulose has been investigated as an alternative to microcrystalline cellulose as an agent to assist the manufacture of pellets by extrusion/spheronization.

• However, powdered cellulose alone requires too much water and due to water movement during extrusion cannot be used as an extrusion/spheronization aid on its own.

• Powdered cellulose is also used widely in cosmetics and food products as an adsorbent and thickening agent.

Incompatible with strong oxidizing agents, bromine pentafluoride, sodium nitrite and fluorine.

Powdered cellulose is widely used in oral pharmaceutical formulations and food products and is regarded as a nontoxic and nonirritant material. However, allergic reactions when inhaled, ingested or in contact with the skin are possible.  Powdered cellulose is not absorbed systemically following peroral administration and thus has little toxic potential. Consumption of large quantities of cellulose may, however, have a laxative effect, although this is unlikely to be a problem when cellulose is used as an excipient in pharmaceutical formulations.

Observe normal precautions appropriate to the circumstances and quantity of material handled. Powdered cellulose may be an irritant to the eyes. The material emits toxic fumes under fire conditions and when heated to decomposition. Gloves, eye protection, and a dust mask (NIOSH approved), and engineering controls such as exhaust ventilation are recommended.

Cellulose, microcrystalline.