GB2619970A — An orodispersible pharmaceutical composition of baclofen and its process of preparation

USPTO Abstract

An orodispersable pharmaceutical composition suitable for oral administration comprising baclofen, at least one disintegrant and at least one diluent. A method of preparing an orally dispersable pharmaceutical composition is also included, comprising: i) weighing raw materials individually, ii) sieving mannitol, microcrystalline cellulose 102 and sodium starch glycolate separately through a #40 sieve and aspartame, orange flavour and magnesium stearate separately through a #60 sieve, iii) preparing a binder solution by dissolving low substituted hydroxypropyl cellulose (L-HPC) in water, iv) dry mixing baclofen, mannitol and microcrystalline cellulose in a rapid mixer granulator, v) adding the binder solution into the granulator, vi) drying the blend at 50oC, vii) passing dry granules through a #24 sieve and retained granules through a multi-mill to pass through a #24 sieve, viii) mixing the granules with mannitol, sodium starch glycolate, aspartame and orange flavour, ix) mixing the blend with magnesium stearate and x) compressing the mixture into a tablet. The composition may comprise at least one excipient selected from a sweetener, flavouring, binder and lubricant and may comprise L-HPC, orange flavour, aspartame and magnesium stearate. The composition may be for treatment of spasticity resulting from multiple sclerosis. The composition may dissolve in under 3 minutes.