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 Pharmaceutical delivery system

Details
Inventors: Baker, Richard W.; Brooke, James W.;
Assignee: Burroughs Wellcome Co. (Research Triangle Park, NC)
Primary Examiner: Griffin; Ronald W.
Assistant Examiner:
Attorney, Agent or Firm: Brown; Donald

A composition for use in an aqueous environment which comprise a formulation containing a water-soluble pharmaceutically beneficial agent, a water-insoluble, water-permeable film coating surrounding the formulation, and particulate, water-soluble, pore-forming material dispersed within the film coating.

DETAILED DESCRIPTION The present invention provides a method and means for dispensing in a controlled, continuous manner therapeutically effective amounts of water-soluble drugs for a predetermined period of time to achieve a predetermined useful effect in animals, especially mammals, including in particular human beings.
In one aspect a core comprising the desired water-soluble beneficial agent together with any desired excipient(s) including osmotic enhancing agents is film coated with a solution of a water-insoluble, water-permeable polymer, a water-permeability-modifying agent (if desired), and a water-soluble, polymer-solvent-insoluble, particulate, pore-forming material.
When the pore-forming material is soluble in the solvent used to dissolve the polymer, it can be suspended in a pore-forming material non-solvent which is compatible with the polymer solution.
The polymer solution and the pore-forming material suspension can then be separately but simultaneously applied, as by spray coating in a pan coater or fluidized bed.
In another aspect of the present invention there is provided a method of simply and reproducibly mass producing osmotically driven, controlled release devices for dispensing water-soluble beneficial agents.
It is contemplated that the controlled release device of the present invention also has utility in non-animal environments such as in agriculture (e.
g.
, for the controlled delivery of fertilizers, soil trace minerals or elements, fungicides, herbicides and the like) or other environments in which it would come into contact with water from time to time or continuously.
When the device of the present invention is used, e.
g.
, by oral administration to a human being, it comes into contact with an aqueous environment.
Water is imbided through the semi-permeable film coating, in the process leaching out the water-soluble particles in the film coating.
The imbided water dissolves the water-soluble beneficial agent as well as osmotic enhancing agents present.
This sets up the osmotic gradient which actively brings in water through the semi-permeable membrane thereby increasing the pressure inside the device, resulting in the saturated (or partially saturated) solution of the beneficial agent being pumped out through the micropassageways created by the water dissolving the pore-forming, watersoluble particles imbedded in the film coating of the device



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