Name: Lactose, Monohydrate and Powdered Cellulose
CAS No:
None adopted.
Cellactose 80.
See Section 8.
See Section 8.
Lactose monohydrate and powdered cellulose can be used in tablets for direct compression to improve compressibility and mouthfeel.(1)
Lactose monohydrate and powdered cellulose occurs as a white or almost white odorless powder containing 73–77% of lactose monohydrate and 23–27% of cellulose powder.
Both lactose monohydrate and powdered cellulose are listed as separate monographs in the JP, PhEur, and USP–NF, but the combination is not listed. See Lactose, Monohydrate, and Cellulose, Powdered
Acidity/alkalinity pH = 4.0–7.0 for Cellactose 80 Angle of repose 32–358 for Cellactose 80 Density (bulk) 0.38 g/cm3 for Cellactose 80 Density (tapped) 0.5 g/cm3 for Cellactose 80 Hausner ratio 1.24 for Cellactose 80 Heavy metals 45 ppm for Cellactose 80 Loss on drying 43.5% for Cellactose 80 Microbial content Total viable aerobic count 4100 cfu/g, molds 410 cfu/g, yeast 410 cfu/g (Escherichia coli and Salmonella species absent) for Cellactose 80 Particle size distribution 420% <32 mm, 35–65% <160 mm, 580% <250 mm for Cellactose 80 Sulfated ash 40.2% for Cellactose 80 Solubility Partially soluble in water for Cellactose 80 Water content 4–7% for Cellactose 80
Store at room temperature in well-closed containers under dry and odor-free conditions.
See Lactose, Monohydrate, and Cellulose, Powdered.
Lactose monohydrate and powdered cellulose is prepared by spraydrying a mixture of the two ingredients.
See Lactose, Monohydrate, and Cellulose, Powdered.
Observe normal precautions appropriate to the circumstances and quantity of material handled.
Lactose monohydrate and powdered cellulose is a mixture of two materials both of which are generally regarded as nontoxic: Lactose monohydrate GRAS listed. Included in the FDA Inactive Ingredients Database (IM, IV, and SC: powder for injections; oral: capsules and tablets; inhalation preparations; vaginal preparations). Included in nonparenteral and parenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. Powdered cellulose GRAS listed. Accepted for use as a food additive in Europe (except for infant food in the UK). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
Lactose, monohydrate; cellulose, powdered.
Lactose monohydrate and powdered cellulose are two of the materials that have been selected for harmonization by the Pharmacopeial Discussion Group. For further information see the General Information Chapter <1196> in the USP32–NF27, the General Chapter 5.8 in PhEur 6.0, along with the ‘State of Work’ document on the PhEur EDQM website, and also the General Information Chapter 8 in the JP XV.