C - Chemistry – Metallurgy – 08 – L
Patent
C - Chemistry, Metallurgy
08
L
C08L 3/02 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 47/36 (2006.01)
Patent
CA 2511718
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.
Bindzus Wolfgang
Green Vincent
Xiao Chaodong
Zhang Yeli
Brunob II B.v.
National Starch And Chemical Investment Holding Corporation
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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