Name: Lactose, Monohydrate and Povidone
CAS No:
None adopted.
Ludipress LCE
See Section 8.
See Section 8.
Lactose monohydrate and povidone can be used to formulate chewable tablets, lozenges, effervescent tablets, and controlledrelease tablets by direct compression.(1) It is suitable for low-dose drugs.
Lactose monohydrate and povidone occurs as white free-flowing granules, odorless with a neutral taste, containing 96.5% 1.8% of lactose monohydrate and 3.5% 0.5% of povidone K30.
Both lactose monohydrate and povidone are listed as separate monographs in the JP, PhEur, and USP–NF, but the combination is not listed. See Lactose, Monohydrate, and Povidone.
Angle of repose 29.58 for Ludipress LCE Density (bulk) 0.56 0.6 g/cm3 for Ludipress LCE Hausner ratio 1.20 0.10 for Ludipress LCE Heavy metals 410 ppm for Ludipress LCE Loss on drying 5.75% for Ludipress LCE Microbial content Mesophilic aerobes 41000 cfu/g, yeasts and fungi 4100 cfu/g (Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella species absent), other Enterobacteriaceae 4100 cfu/g) for Ludipress LCE Particle size distribution 420% <63 mm, 40–65% <200 mm, 420% <400 mm for Ludipress LCE Solubility Soluble in water for Ludipress LCE Water content 46.0% for Ludipress LCE
Store at room temperature in tightly closed containers.
See Lactose, Monohydrate, and Povidone.
Lactose monohydrate and povidone is manufactured by a proprietary agglomeration process
See Lactose, Monohydrate, and Povidone.
Observe normal precautions appropriate to the circumstances and quantity of material handled.
Lactose monohydrate and povidone 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. Povidone Accepted for use in Europe as a food additive. Included in the FDA Inactive Ingredients Database (IM and IV injections; ophthalmic preparations; oral capsules, drops, granules, suspensions, and tablets; sublingual tablets; topical and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Nonmedicinal Ingredients
Lactose, monohydrate; povidone.
Lactose monohydrate and povidone 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. Ludipress LCE has been shown to have compression characteristics superior to a simple physical mixture of its constituents.(3,4) Tablet strength has been shown to be independent of machine speed(5) and tablet geometry,(5) and does not increase on storage.(6) Disintegration time has been shown not to increase at high compression forces.