Patent Number: 8,871,270

Title: Tablet excipient

Abstract: This invention relates to a composition comprising physically modified, partially pregelatinized starch, which is useful as a multi-functional excipient for solid dosage forms, a method of making such composition, and solid dosage forms prepared using the composition. Such composition is characterized by a predominance of particles having both birefringent and non-birefringent portions, a sedimentation volume of between 1.5 and 9 ml/g, and a cold water solubility of between 1 and 8%. This free-flowing starch may have an average particle size greater than 30 .mu.m, and a moisture content of between 5 and 12% by weight. The 500 mg placebo tablet prepared from such composition at 13 kN using a manual tablet press equipped with a 1.11 cm ( 7/16'') standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes.

Inventors: Zhang; Yeli (Somerville, NJ), Xiao; Chaodong (East Hanover, NJ), Bindzus; Wolfgang (Hillsborough, NJ), Green; Vincent (Plainfield, NJ)

Assignee: Corn Products Development, Inc

International Classification: A61K 9/14 (20060101)

Expiration Date: 2018-10-28 0:00:00