GB2614972A — Stable composition of chloral hydrate

USPTO Abstract

A chloral hydrate solution comprising chloral hydrate in an amount ranging from 20 mg/ml to 100 mg/ml and one or more pharmaceutically acceptable buffers such that the solution has a pH of 3.2 to 4.5 is provided. The solution is stable over a period of at least 24 months when stored below 25 °C, such that the solution contains no more than 300 ppm of chloroform, no more than 800 ppm of formic acid and no more than 100 ppm of monochloroacetaldehyde. The solution may further comprise one or more of a pH adjusting agent, diluent, sweetener, flavouring agent, and antimicrobial agent. The buffer may be selected from citrate, acetate, phosphate, and mixtures thereof, preferably a mixture of citric acid and sodium citrate. The therapeutic use of the solution in sedating a subject is provided. A method of preparing the chloral hydrate solution comprising mixing the chloral hydrate with one or more pharmaceutically acceptable excipients in an aqueous solution is provided. An example composition comprises chloral hydrate, citric acid, sodium citrate, glucose, glycerol, sodium benzoate, saccharin sodium, essence of passion fruit and water. The solution may comprise chloral hydrate at a strength of 500 mg/5ml or 143 mg/5ml.