Terfenadine oral granules

摘要

The present invention contemplates a dry, granular terfenadine composition. That composition comprises (i) particulate terfenadine and (ii) a polyethylene oxide-polypropylene oxide-polyethylene oxide block copolymer having an HLB number of 24 that is a wetting agent for the terfenadine that are dry-blendedly dispersed onto (iii) spray-dried sorbitol particles that are loosely packed, randomly oriented filamentary crystals having pores that entrap the particulate terfenadine and wetting agent upon the dry-blended dispersal. The weight ratio of particulate terfenadine to the block copoymer is about 1:1 to about 1:5:1, and the weight ratio of terfenadine to the spray-dried sorbitol is about 1:4 to about 1:10. The composition is free-flowing and is substantially free from the taste of solubilized terfenadine when placed on the human tongue in dry form or when dispersed in water and tasted within about five minutes of said dispersal. A preferred composition further includes dry-blendedly admixed polyvinylpyrrolidone present in an amount of about 0.5 to about 5 weight percent of the total composition. Flavorants can also be present.