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US1A1 - Tablet excipient - Google Patents US1A1 - Tablet excipient - Google Patents Tablet excipient Info Publication number US1A1 US1A1 US10/888,360 US88836004A USA1 US 1 A1 US1 A1 US 1A1 US 88836004 A US88836004 A US 88836004A US A1 US A1 US A1 Authority US United States Prior art keywords composition starch tablet method μm Prior art date 2004-07-09 Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.) Granted Application number US10/888,360 Other versions Inventor Yeli Zhang Chaodong Xiao Wolfgang Bindzus Vincent Green Current Assignee (The listed assignees may be inaccurate.

Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Corn Products Development Inc USA Original Assignee National Starch and Chemical Investment Holding Corp Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2004-07-09 Filing date 2004-07-09 Publication date 2006--07-09 Application filed by National Starch and Chemical Investment Holding Corp filed Critical National Starch and Chemical Investment Holding Corp 2004-07-09 Assigned to NATIONAL STARCH AND CHEMICAL INVESTMENT HOLDING CORPORATION reassignment NATIONAL STARCH AND CHEMICAL INVESTMENT HOLDING CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BINDZUS, WOLFGANG, GREEN, VINCENT, XIAO, CHAODONG, ZHANG, YELI 2004-07-09 Priority to US10/888,360 priority Critical patent/US8871270B2/en 2006-01-12 Publication of US1A1 publication Critical patent/US1A1/en 2008-06-12 Assigned to BRUNOB II B.V. Reassignment BRUNOB II B.V. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NATIONAL STARCH AND CHEMICAL INVESTMENT HOLDING CORPORATION 2012-02-02 Assigned to CORN PRODUCTS DEVELOPMENT, INC. Reassignment CORN PRODUCTS DEVELOPMENT, INC.

ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BRUNOB II B.V., NATIONAL STARCH LLC 2014-10-28 Publication of US8871270B2 publication Critical patent/US8871270B2/en 2014-10-28 Application granted granted Critical 2019-03-10 Application status is Expired - Fee Related legal-status Critical 2028-12-25 Adjusted expiration legal-status Critical Links • • • • • Images • • • • • • • • • • • • Classifications • • A— HUMAN NECESSITIES • A61— MEDICAL OR VETERINARY SCIENCE; HYGIENE • A61K— PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES • A61K47/00— Medicinal preparations characterised by the non-active ingredients used, e.g. Carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient • A61K47/30— Macromolecular organic or inorganic compounds, e.g. Inorganic polyphosphates • A61K47/36— Polysaccharides; Derivatives thereof, e.g.

Gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin • • A— HUMAN NECESSITIES • A61— MEDICAL OR VETERINARY SCIENCE; HYGIENE • A61K— PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES • A61K9/00— Medicinal preparations characterised by special physical form • A61K9/20— Pills, tablets, discs, rods • A61K9/2004— Excipients; Inactive ingredients • A61K9/2022— Organic macromolecular compounds • A61K9/205— Polysaccharides, e.g. 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 1.11 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. This invention relates to a physically modified, partially pregelatinized starch composition which is useful as a multi-functional excipient for solid dosage forms. It is characterized by a predominance of particles having both birefringent and non-birefringent portions, wherein the birefringent portions may be bonded together by the 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 typically has an average particle size greater than 30 μm, and a moisture content of between 5 and 12% by weight.