04072535 is referenced by 58 patents and cites 9 patents.

A free-flowing binder-disintegrant powder material consisting essentially of a precompacted-starch powder, especially adapted for use in direct compression tabletting machines to produce non-friable tablets having excellent disintegration properties. This precompacted-starch powder is also useful as a free-flowing filler for blending with dry powder ingredients in dry-dosage capsules. The precompacted-starch powder is obtained by subjecting an ungelatinized granular starch to physical compaction without supplementary thermal energy, but with sufficient mechanical energy input to obtain a precompacted-starch having birefringent granules and non-birefringent fragments of granules and some aggregates of granules and fragments, and then dried to a moisture content of 9-16% total weight basis. After precompacting, the starch is pulverized to form a free-flowing powder having a loose bulk density of 0.5 to about 0.7 grams per milliliter. The precompacted-starch powder is essentially free of +40 mesh particles, at least 90% of the particles are -80 mesh, at least about 10% is +270 mesh, and from about 30% to 90% is -270 mesh size on a total weight basis (U.S. Standard Sieve Series, A.S.T.M. Specifications).

Cold water solubility of the precompacted-starch powder is in the range of from 4% to about 40% by weight, preferably about 10% to 20% by weight, and this powder is capable of being formed into a hard, non-friable tablet in combination with other active ingredients in a direct compression tabletting machine, the precompacted-starch powder being dually functional as both a binder and disintegrant. The resulting tablet has a hardness index of at least about 4 kilograms, preferably at least 8 kilograms, a friability loss of less than 1% by weight, a swelling power of 2.5 to about 12, preferably at least 8, and is capable of effectively disintegrating when placed in water.

Title
Precompacted-starch binder-disintegrant-filler material for direct compression tablets and dry dosage capsules
Application Number
646496
Publication Number
4072535
Application Date
September 26, 1975
Publication Date
February 7, 1978
Inventor
Frank Verbanac
Decatur
IL, US
Rolland W P Short
Decatur
IL, US
Agent
Charles J Meyerson
Howard J Barnett
Assignee
A E Staley Manufacturing Company
IL, US
IPC
C08L 3/02
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