Controlled release delivery device for macromolecular proteins

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Specially adapted for ruminant animal

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424484, 424464, 424489, 424490, A23K 118

Patent

active

052195724

ABSTRACT:
A controlled release delivery device for macromolecular proteins which comprises a water-soluble outer capsule completely surrounding an inner compartment containing a plurality of non-uniform beadlets. The beadlets comprise a rupturable wax shell which completely surrounds a core matrix containing the macromolecular proteins and optional "core agents" such as excipients, stabilizers, binders, surfactants, preservatives, or mixtures thereof, and the like.
The water-soluble outer capsule dissolves when the device is administered to an animal and simultaneously exposes substantially all of the beadlets to an aqueous environment. Each beadlet absorbs fluid from the environment and separately ruptures over a prolonged period thus delivering the macromolecular protein to the animal.

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patent: 4196187 (1980-04-01), Dannelly et al.
patent: 4842863 (1989-06-01), Nishimura et al.
patent: 4894234 (1990-01-01), Sharma et al.
patent: 4975280 (1990-12-01), Schect et al.
Ueda et al., Design and Development of Time-Controlled Explosion System (TES) as a Controlled Drug Release System, Proceed. Intern. Symp. Control. Rel. Bioact. Mater. 15, 1988, Controlled Release Society, Inc. discloses an oral controlled drug release system which contains a drug and a swelling agent and is coated with a water-insoluble polymer, The device releases the drug after a "lag time", which depends upon the thickness of the membrane, The osmotic agent (sucrose bead), drug, swelling agent and polymer membrane are arranged on concentric layers to produce the bead.

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