Cellulose, powdered

• BPPowdered Cellulose
• JPPowdered Cellulose
• Ph. Eur.Cellulose, Powdered
• USP–NFPowdered Cellulose

Arbocel; cellulosi pulvis; Elcema; KC Flock; Sanacel; Solka-Floc; E460(ii)

Cellulose · [9004-34-6]

(C6H10O5)n, n ≈ 500 · ≈ 243 000

Diluent (filler)

Typical concentrations: — · Dosage forms: Solid

Used as a tablet and capsule diluent (filler), and also as a tablet binder and disintegrant, a glidant, a suspending or thickening agent and a carrier in oral and topical products. Typical concentrations: capsule filler 0–100%; tablet binder 5–25%; tablet disintegrant 5–15%; glidant 1–2%. It is also used in foods as a source of dietary fibre and as an anticaking agent.

A white or almost white, odourless and tasteless powder of various particle sizes, ranging from a free-flowing fine or granular powder to a coarse, fluffy, non-flowing material.

Degree of polymerisation

not less than 440 (higher than microcrystalline cellulose)

pH

5.0–7.5 (supernatant of a 10% w/v aqueous dispersion)

Particle size and flow

grades range from fine, free-flowing powders to coarse, fluffy, poorly flowing materials

Moisture

slightly hygroscopic; loss on drying typically not more than 6.5%

Solubility

practically insoluble in water, dilute acids and most organic solvents; slightly soluble in 5% w/v sodium hydroxide solution

Stable, though slightly hygroscopic. Store in a well-closed container in a cool, dry place.

Incompatible with strong oxidising agents.

Obtained by purification and mechanical size reduction of α-cellulose, which is prepared as a pulp from fibrous plant material such as wood; unlike microcrystalline cellulose it is not hydrolysed to remove the amorphous regions.

Widely used in oral products and foods and regarded as non-toxic and non-irritant; it is not absorbed after oral administration. Large quantities may have a laxative effect. Deliberate injection or inhalation of crushed tablets has led to cellulose granulomas.

Observe normal precautions for the quantity handled. The dust may irritate the eyes; gloves, eye protection and a dust mask are recommended. Fine cellulose dust can form explosive mixtures with air.

GRAS listed. Accepted as a food additive in Europe (E460). Included in the FDA Inactive Ingredient Database (oral capsules, suspensions and tablets) and in non-parenteral medicines licensed in Europe.

Microcrystalline cellulose; silicified microcrystalline cellulose; cellulose acetate.

Powdered cellulose is less crystalline and less compressible than microcrystalline cellulose, and its poorer flow makes it less suitable as the sole filler in direct compression; it is more often used in wet granulation and capsule filling. Low-crystallinity grades have been developed with improved compaction.