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AssigneeCerestar Holdings B.V.
InventorsJacques Marie Loic Michaud, Dirk Reimond Provoost, Elsie Van Bogaert
Estimating the term…
A directly compressible starch consisting in an intense white free-flowing powder showing both excellent compression profile and extremely good disintegration properties. This starch is especially designed to be used as a binder in direct compression processes where it yields very hard white tablets at relatively low compression forces. Tablets resulting from the compression of the above mentioned starch disintegrate in an aqueous medium at a very high speed and they additionally exhibit low friability pattern. This free-flowing starch also brings advantages when used as filler and binder in the filling of some hard gelatine capsules especially for these which are filled by pre-compression of the ingredients. This starch is characterized by regular and smooth partially swollen granules which can be either birefringent or non-birefringent. It can be prepared by spray-drying of a partially cooked starch.
A free-flowing directly compressible processed starch powder in that comprises regular and smooth partially swollen granules of starch, wherein the ratio of non-swollen birefringent granules to swollen non-birefringent granules is in the range of from 1:5 to 5:1 and has an average particle size greater than 50 .mu.m and a moisture content of from 3 to 15% by weight, wherein when said free-flowing compressible processed starch powder is compressed into a tablet under a compression force of 10 kN gives a tablet having a tensile strength of at least 1 N/mm.sup.2.
A process for preparing a free-flowing compressible starch powder comprising the steps;
A dry compressed tablet comprising at least one active material and, as binder or filler, processed starch, said processed starch comprising regular and smooth partially swollen granules of starch wherein the ratio of non-swollen birefringent granules to swollen birefringent granules is in the range of from 1:5 to 5:1 and having an average particle size greater than 50 .mu.m and a moisture content in the range of from 3 to 15% by weight, said tablet, when formed under a compression force of 15 kN having a tensile strength greater than 1 N/mm.sup.2, a disintegration time in water at 37.degree. C. of less than 6 minutes and % friability of less than 1%.
A process for producing a dry compressed tablet from a free-flowing directly compressible process starch powder, said free-flowing directly compressible starch powder comprising regular and smooth partially swollen granules of starch wherein the ratio of non-swollen birefringement granulers to swollen non-birefringement granules is in the range of 1:5 to 5:1 and as having an average particle size greater than 50 .mu.m and a moisture content of from 3 to 15% by weight, said process comprising directly compressing the starch powder under a low compression force of at least 10 kN to obtain a tablet having a tensile strength of at least 1 N/mm.sup.2.
Dependencies are inferred from the claim text.