Manufacture of cross-linked amylose useful as a excipient for co

Details Manufacture of cross-linked amylose useful as a excipient for co Manufacture of cross-linked amylose useful as a excipient for co

1997-02-14

1998-09-15

Woodward, Michael P.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

424468, 424489, 424493, A61K 922, A61K 914

Patent

active

058075755

ABSTRACT:
A process for the manufacture of a slow-release excipient consisting mainly of cross-linked amylose in the form of solid particles, for use in the preparation of tablets or pellets. A starch containing a high amount of amylose (high amylose starch) is first subjected to a gelatinization. The gelatinized high amylose starch is then cross-linked with 1 to 5 g of a cross-linking agent per 100 g of dry-based gelatinized high amylose starch in an alkali medium, thereby forming a reaction medium containing a reaction product consisting of a cross-linked high amylose starch slurry. The obtained reaction medium is neutralized, thereby forming by-products mainly consisting of salts, which are removed from the reaction medium. The recovered cross-linked high amylose starch slurry is then subjected to a thermal treatment at a temperature of at least 60.degree. C. and the thermally treated product is dried to obtain the requested slow release excipient. This process is economical and industrially advantageous since it is carried out in an aqueous medium.

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