GB2634218A — Powder for oral solution formulations

USPTO Abstract

A powder for oral solution formulation comprising an active pharmaceutical agent in an amount of 1-25 % w/w, a taste masking bulking agent in an amount of 60-99 % w/w, a binder in an amount of 0-10 % w/w, a taste modifying component in an amount of 0-10 % w/w and a flow agent in an amount of 0-10 % w/w. The taste-masking bulking agent may comprise a sugar alcohol (e.g., mannitol, sorbitol, xylitol); the binder may be a polysaccharide (e.g., starch, cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose); the taste-modifying agent may comprise a flavouring (e.g., fruit or herb oil, synthetic flavouring) and/or sweetener (e.g., acesulfame salt); the flow agent may comprise a silicate, talc, stearic acid or salt thereof, and/or a phosphate. The active pharmaceutical agent may be an analgesic or an anti-epileptic agent; and may not be a beta lactam. The formulation may include less than 0.1 % w/w each of a preservative and/or sugar. Also disclosed is a method of preparing the described powder, wherein the method comprises blending the active pharmaceutical agent with the taste masking bulking agent, and optionally with the binder, taste-modifying agent and/or flow agent.