Oral solution containing galanthamine, method for preparing thereof and its use in preparation of medicaments

• Main Authors: KEMPEN TONY MATHILDE JOZEF, FRANCOIS MARC KAREL JOZEF, DE PROOST EDDY ANDRU JOSS
• Format: Patent
• Language: Czech; English
• Published: 01.09.2010
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

Perorální roztok obsahující galantamin nebo jeho farmaceuticky prijatelnou adicní sul, který obsahuje od 0,005 do 3 % hmotn./obj. sladidla, prednostne silného sladidla, a jeho objemový tekutý nosic je vodný. Objemovým tekutým nosicem je prednostne nepufrovaný vodný roztok. Použití tohoto roztoku pro výrobu léciva pro lécení napríklad Alzheimerovy nemoci a príbuzných demencí. Zpusob prípravy tohoto roztoku, pri nemž se mísí galantamin nebo jeho farmaceuticky prijatelná adicní sul, silné sladidlo, poprípade další farmaceuticky prijatelné pomocné látky a objemový tekutý nosic až do úplného rozpuštení, pH vzniklého roztoku se poprípade nastavuje na hodnotu 4 až 8 a výsledný roztok se redí na požadovaný konecný objem cištenou vodou. In the present invention, there is disclosed an oral solution containing galanthamine or its pharmaceutically acceptable addition salt, said oral solution containing from 0.005 to 3 percent by weight/volume of a sweetening agent, preferably an intense sweetening agent, and its bulk liquid carrier is aqueous. The bulk liquid carrier is preferably a non-buffered aqueous solution. There is also disclosed the use of the above-described solution for treating for example AlzheimerÆs disease and related dementia. Further disclosed is a method for preparing this solution, said method comprising the steps of mixing galanthamine or a pharmaceutically acceptable addition salt thereof, intense sweetener, optionally other pharmaceutically acceptable excipients and a bulk liquid carrier until complete dissolution, optionally the pH of the resulting solution being adjusted to pH 4 to 8; and the resulting solution is diluted to the desired end-volume with purified water.