Process for the preparation of shaped, compressed controlled-rel

Details Process for the preparation of shaped, compressed controlled-rel Process for the preparation of shaped, compressed controlled-rel

1994-12-15

1998-11-24

Marquis, Melvyn I.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

424468, 424469, 424470, 424484, 424485, 424488, A61K 920

Patent

active

058403302

ABSTRACT:
Process for the preparation of shaped, compressed controlled-release unit-dosage forms from a therapeutic active substance exhibiting a self-retarding release that depends on the magnitude of the force used for the compression. The process gives unit-dosage forms for which the release of the active substance is highly uniform, reproducibly identical and largely linear. To achieve this, the active substance and an additive charge that inhibits or compensates for the self-retardation of its release are processed into particles in the first stage of production, so that the preliminary compressed objects made from these particles without any further additives exhibit a rapid release (in comparison with the required controlled release) over the range of the force of compression envisaged for the production of the unit-dosage form in question, after which the particles are compressed in the second stage of production with a release-retarding agent to obtain the unit-dosage forms. The invention also relates to the unit-dosage forms thus obtained.

REFERENCES:
patent: 3629393 (1971-12-01), Nakamoto et al.
patent: 4540566 (1985-09-01), Davis et al.
patent: 4608248 (1986-08-01), Knecht et al.
patent: 5075114 (1991-12-01), Roche
patent: 5128142 (1992-07-01), Mulligan et al.
patent: 5215755 (1993-06-01), Roche et al.

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