AMORPHOUS ALPRAZOLAM COMPOSITIONS WITH ANXIOLYTIC ACTIVITY WITH ETHYL CELLULOSE AND CROSPOVIDONE AND CORRESPONDING METHODS

摘要

The invention relates to an amorphous alprazolam composition with anxiolytic activity, which comprises: a) a premixture containing: 0.33-0.66% w/w alprazolam; 0.07-0.2% w/w ethyl cellulose as a binding agent; a disintegrating agent, a diluting agent, aspartame and a flavour masking agent; and b) the premixture combined with: 4-6% w/w water-insoluble crospovidone as a disintegrating agent; a lubricating agent; flavouring agents, sweetening agents and q.s. 100% granular mannitol as a diluent, wherein: the ratio of alprazolam to ethyl cellulose in the premixture is in the range of 2.5:1 to 5:1; the ratio of alprazolam to water-insoluble crospovidone is in the range of 0.06:1 to 0.13:1; and the degree of crystallinity of alprazolam is less than 10%.