International Numbering System (INS) for Food Additives: 460
Food additives Europe numbers: E460
Functional Category
Adsorbent; suspending agent; tablet and capsule diluent; tablet disintegrant
Applications in Pharmaceutical Formulation
Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a binder/diluent in oral tablet and capsule formulations where it is used in both wet-granulation and direct-compression processes.(1–7) In addition to its use as a binder/diluent, microcrystalline cellulose also has some lubricant(8) and disintegrant properties that make it useful in tableting Microcrystalline cellulose is also used in cosmetics and food products; see Table I
Description
Microcrystalline cellulose is a purified, partially depolymerized cellulose that occurs as a white, odorless, tasteless, crystalline powder composed of porous particles. It is commercially available in different particle sizes and moisture grades that have different properties and applications.
Stability and Storage Conditions
Microcrystalline cellulose is a stable though hygroscopic material. The bulk material should be stored in a well-closed container in a cool, dry place.
Incompatibilities
Microcrystalline cellulose is incompatible with strong oxidizing agents
Safety
Microcrystalline cellulose is widely used in oral pharmaceutical formulations and food products and is generally regarded as a relatively nontoxic and nonirritant material. Microcrystalline cellulose is not absorbed systemically following oral administration and thus has little toxic potential. Consumption of large quantities of cellulose may have a laxative effect, although this is unlikely to be a problem when cellulose is used as an excipient in pharmaceutical formulations. Deliberate abuse of formulations containing cellulose, either by inhalation or by injection, has resulted in the formation of cellulose granulomas.(13