IMMEDIATE RELEASE UNITARY DOSES OF GHB OR ONE OF ITS THERAPEUTICALLY ACCEPTABLE SALTS ADMINISTERED VIA ORAL ROUTE AND THEIR USE FOR MAINTAINING ABSTINENCE FROM ALCOHOL
The present invention concerns immediate release, unit doses of GHB or one of the therapeutically acceptable salts thereof administered via oral route.Such unit doses contain between 0.37 and 1.75 g of GHB, more particularly as sodium oxybate when under the form of granules, these granules have the following composition (weight % relative to the total weight of the granule): -Active ingredient (sodium oxybate): 50 to 60 % -Effervescent agent: 5 to 15 % -Diluent: 2 to 18 % -Binder: 3 to 10 % -Substrate (Solid core of the granule): 15 to 25 % -Coating agent/ flavouring agent / sweetening agent / lubricant: 3 to 6 %.Application for maintaining abstinence from alcohol of patients with mild or moderate alcohol dependence or with severe or very severe alcohol dependence, either suffering or not from liver disease.本發明係關於經由口服途徑投予之立即釋放的GHB或其治療上可接受的鹽之一者的單位劑型。此種單位劑型含有0.37至1.75g之GHB,更特別是為羥丁酸鈉;當於顆粒形式時,此等顆粒具有下列組成(相對於顆粒總重量之重量%):-活性成分(羥丁酸鈉):50至60%;-發泡劑:5至15%;-稀釋劑:2至18%;-黏合劑:3至10%;-基質(顆粒之固體核心):15至25%;-塗布劑/調味劑/甜味劑/潤滑劑:3至6%。用於罹患或未罹患肝臟疾病之具輕度或中度酒精依賴的病患或具嚴重或極嚴重酒精依賴的病患中維持酒精戒斷的應用。
