| 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 µm, 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 1.11cm (7/16") standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes. |