Calcium Lactate

Category

Binder Excipients

Grade

Pharmceutical Excipients

Description

Calcium lactate occurs as white or almost white, crystalline or granular powder. It is slightly efflorescent.

UNII

2URQ2N32W3

Chemical Name

Calcium lactate anhydrous

CAS Number

814-80-2

Synonyms

Calcii lactas pentahydricus; calcium bis(2-hydroxypropanoate)pentahydrate; calcium dilactate; calcium lactate (1:2) hydrate; calcium lactate (1:2) pentahydrate; E327; 2-hydroxypropanoic acid, calcium salt; lactic acid, calcium salt; mixture of calcium (2R)-, (2S)- and (2RS)-2-hydroxypropanoates pentahydrates; propanoic acid, 2-hydroxy-, calcium salt (2:1), hydrate; Puracal.

Administration route

Vaginal

Dosage Form

Vaginal, tablet

Stability and Storage Conditions

Calcium lactate can exist in a number of hydration states, which are characterized as anhydrous, monohydrate, trihydrate, and pentahydrate. Dehydration of the pentahydrate form is rapid at temperatures of 55℃ and above. Dehydration is reported to be accompanied by some loss of crystallinity. Tablet crushing strength was reported to be reduced following dehydration of calcium lactate pentahydrate.

Source and Preparation

Calcium lactate is prepared commercially by neutralization with calcium carbonate or calcium hydroxide of lactic acid obtained from fermentation of dextrose, molasses, starch, sugar, or whey.

Applications

Calcium lactate is used as a bioavailability enhancer and nutrient supplement in pharmaceutical formulations. A spray-dried grade of calcium lactate pentahydrate has been used as a tablet diluent in direct compression systems, and has been shown to have good compactability. The properties of the pentahydrate form have been considered superior to those of calcium lactate trihydrate when used in direct compression tablet formulations.Tablet properties may be affected by the hydration state of the calcium lactate and particle size of the material: reducing particle size increased crushing strength, whereas storage of tablets at elevated temperature resulted in dehydration accompanied by a reduction in crushing strength. Calcium lactate has also been used as the source of calcium ions in the preparation of calcium alginate microspheres for controlled-release delivery of active agents. It has been shown to result in lower calcium concentrations in the finished microspheres when compared with calcium acetate. Therapeutically, calcium lactate has been used in preparations for the treatment of calcium deficiency.

Safety

Calcium lactate was found to have no toxic or carcinogenic effects when dosed at levels of 0%, 2.5%, and 5% in drinking water to male and female rats for 2 years.

Incompatibilities

Calcium salts, including the lactate, can display physical incompatibility with phosphate in the diet or therapeutic preparations, for example in enteral feed mixtures.