Name: Lactose, Monohydrate and Corn Starch
CAS No:
None adopted.
StarLac.
See Section 8.
See Section 8.
Lactose monohydrate and corn starch can be used in tablets to improve compressibility, flowability and disintegration properties.(1) It is used in homeopathic and low-dose to mid-dose formulations
a-Lactose monohydrate and corn starch occurs as a white or almost white odorless powder containing 82–88% of lactose monohydrate and 12–18% of corn (maize) starch. It is a free-flowing powder owing to its spherical structure.
Both lactose monohydrate and corn (maize) starch are listed as separate monographs in the JP, PhEur, and USP–NF, but the combination is not listed. See Lactose, Monohydrate, and Starch.
Angle of repose 4298 for StarLac Density (bulk) 0.57 g/cm3 for StarLac Density (tapped) 0.68 g/cm3 for StarLac Hausner ratio 1.19 for StarLac Heavy metals 5 ppm for StarLac Loss on drying 43.0% for StarLac Microbial content Total viable aerobic count 4100 cfu/g, molds <10 cfu/g, yeasts <10 cfu/g (Escherichia coli and Salmonella species absent) for StarLac. Particle size distribution 415% <32 mm, 35–65% <160 mm, 580% <250 mm for StarLac. Sulfated ash 40.25% for StarLac Solubility Partially soluble in cold water for StarLac.
Store in well-closed containers under dry and odor-free conditions.
See Lactose, Monohydrate, and Starch
Lactose monohydrate and corn starch is prepared by spray-drying a mixture of the two ingredients.
See Lactose, Monohydrate, and Starch.
Observe normal precautions appropriate to the circumstances and quantity of material handled.
Lactose monohydrate and corn starch 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. Starch GRAS listed. Included in the FDA Inactive Ingredients Database (buccal tablets, oral capsules, powders, suspensions and tablets; topical preparations; and vaginal tablets). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
Lactose, monohydrate; starch.
Lactose monohydrate and corn starch 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. StarLac has been designed for direct compression, combining good flowability and compressibility with fast disintegration properties. Excipients or formulations containing a variety of drugs, namely ascorbic acid, paracetamol [acetaminophen] and theophylline monohydrate show it to be superior to a simple mixture of its components in terms of flowability, tablet strength, friability and disintegration time.(1,2) Starch particles are embedded in a matrix mainly consisting of crystalline lactose monohydrate, and very low quantities of amorphous lactose are detectable. Its balanced elastic and brittle properties make it suitable for roller compaction. Specific quantitative, analytical methods for the assay of starch and lactose in StarLac have been developed and validated.(3)