Soft chew pharmaceutical formulations

A process for manufacture of an edible, soft-chew, semi-plastic tablet unit dosage form for the oral administration of an active ingredient comprising the steps of:

• (a) combining a plurality of ingredients to form a mixture;
• said ingredients comprising:
• said active ingredient in a concentration ranging from 0.1% w/w to 20% w/w, polyethylene glycol in a concentration ranging from 0.1% w/w to 12% w/w, povidone in a concentration ranging from 0.1% w/w to 3% w/w, and microcrystalline cellulose in a concentration ranging from 0.1% w/w to 35% w/w;
• (b) sifting said mixture to form granules;
• (c) compressing said granules using a tablet press to form said tablet,
• wherein said tablet has:
• a hardness of less than 2 kp when measured on a tablet hardness tester;
• a friability of less than 1% at 100 rotations when tested in accordance with United States Pharmacopeia test <1216>;
• a water content ranging from 4% w/w to 15% w/w of total weight of the tablet;
• and
• a disintegration time of less than 60-minutes when measured in accordance with United States Pharmacopeia test <701>,
• wherein said process does not include a heating step,
• wherein said tablet is formed without molding or extrusion.