| abstract |
FIELD: medicine. n SUBSTANCE: present invention relates to dissolution powder before use of injectable preparations containing melatonin, at least one water-soluble excipient and at least one water-soluble surfactant for the treatment of neonatal cerebral infarction. This water-soluble excipient contains leucine. Melatonin powder has X90 of less than 100 microns and an average bulk diameter of less than 50 microns. Powder is obtained from a solution containing melatonin by spray drying. Present invention also relates to injectable preparation in form of solution obtained by dissolving the powder containing melatonin, in a mixture of water and a polyalkylene glycol in which melatonin is present in an amount of from 3 to 30 mg/ml and the polyalkylene glycol is present in an amount of 5 to 40 % of the total volume of the liquid used. Method for producing melatonin powder, a kit for preparing the solution immediately before administration, is also described. n EFFECT: invention provides rapid dissolution of melatonin powder before use and stability of melatonin in solution. n 17 cl, 8 tbl, 13 ex |