Controlled release dosage form including a banded engine

• US 20050186273A1
• Filed: 09/24/2004
• Published: 08/25/2005
• Est. Priority Date: 09/26/2003
• Status: Abandoned Application

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Dong, Liang-Chang, Pollock-Dove, Crystal, Wong, Patrick S. L., Yum, Si-Hong
• Application Number:
  US10/950,039
• Publication Number:
  US 20050186273A1
• Time in Patent Office: Days
• US Class Current: 424/464
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

The present invention includes a dosage form configured to provide the controlled release of an active agent formulation. A dosage form according to the present invention includes a reservoir containing an active agent formulation and an engine positioned at least partially within the reservoir. In order to reduce the possibility that the engine included in a dosage form of the present invention will separate from the reservoir either during or after fabrication, the dosage form of the present invention includes a band that binds the engine to the reservoir. The band is provided over an outside surface of the both the engine and the reservoir at or near the interface formed where the engine enters the opening provided in the reservoir. The present invention also includes a method of fabricating controlled release dosage forms having banded engine.

Claims

1. A dosage form configured to provide the controlled release of an active agent formulation comprising

a reservoir containing an active agent formulation,

an engine partially positioned within the reservoir, and the engine not being completely encapsulated by the reservoir, and

a band provided over an outer surface of the reservoir and the engine that binds the engine to the reservoir;

wherein the dosage form is configured to expel the active agent formulation from within the reservoir at a controlled rate after administration of the dosage form to an environment of operation.

2. The dosage form of claim 1, wherein the band is a printed band, extrusion coated band, screen coated band, brush coated band, sprayed band, or painted band.

3. The dosage form of claim 1, wherein the band comprises a band formed continuously around the dosage form in an area where the engine and reservoir come together.

4. The dosage form of claim 1, wherein the band comprises material selected from the group consisting of polyethylene, polystyrene, ethylene-vinyl acetate copolymers, polycaprolactone and polyester based elastomers, polysaccharides, cellulosics, powdered cellulose, microcrystalline cellulose, cellulose acetate, cellulose acetate pseudolatex, cellulose acetate propionate, cellulose acetate butyrate, ethyl cellulose, ethyl cellulose pseudolatex, nitrocellulose, polylactic acid, poly-glycolic acid, polylactide glycolide copolymers, collagen, polycaprolactone, polyvinyl alcohol, polyvinyl acetate, polyethylene vinylacetate, polyethylene teraphthalate, polybutadiene styrene, polyisobutylene, polyisobutylene isoprene copolymer, polyvinyl chloride, polyvinylidene chloride-vinyl chloride copolymer, copolymers of acrylic acid and methacrylic acid esters, copolymers of methylmethacrylate and ethylacrylate, latex of acrylate esters, polypropylene, copolymers of propylene oxide and ethylene oxide, propylene oxide ethylene oxide block copolymers, ethylenevinyl alcohol copolymer, polysulfone, ethylene vinylalcohol copolymer, polyxylylenes, polyamides, natural and synthetic waxes, paraffin, carnauba wax, petroleum wax, white or yellow bees wax, castor wax, candelilla wax, rice bran wax, microcrystalline wax, stearyl alcohol, cetyl alcohol, bleached shellac, esterified shellac, chitin, chitosan, silicas, polyalkoxysilanes, polydimethyl siloxane, polyethylene glycol-silicone elastomers, crosslinked gelatin, zein, electromagnetic irradiation crosslinked acrylics, silicones, or polyesters, thermally crosslinked acrylics, silicones, or polyesters, butadiene-styrene rubber, glycerol ester of partially dimerized rosin, glycerol ester of partially hydrogenated wood rosin, glycerol ester of tall oil rosin, glycerol ester of wood rosin, pentaerythritol ester of partially hydrogenated wood rosin, pentaerythritol ester of wood rosin, natural or synthetic terpene resin and blends of the above.

5. The dosage form of claim 1, wherein the band comprises a tape.

6. The dosage form of claim 1, wherein the band comprises a preformed band.

7. The dosage form of claim 1, wherein the engine comprises an osmotic engine.

8. The dosage form of claim 7, wherein the osmotic engine comprises

an expandable osmotic composition.

9. The dosage form of claim 7, wherein the osmotic engine comprises a barrier layer or an outer coating that limits migration of an active agent formulation from the reservoir into the osmotic engine.

10. The dosage form of claim 1, wherein the reservoir comprises a water permeable material.

11. The dosage form of claim 1, wherein the reservoir comprises a material that is substantially impermeable to water.

12. A dosage form comprising

a reservoir containing an active agent formulation,

an osmotic engine partially positioned within an opening formed within the reservoir, and the osmotic engine not being completely encapsulated by the reservoir,

a band provided over an outer surface of the reservoir and the engine that binds the engine to the reservoir,

a rate controlling membrane, and

an exit orifice through which the active agent formulation can be delivered.

13. A method of manufacturing a dosage form providing the controlled release of an active agent formulation comprising:

providing a reservoir having an opening that is sized and shaped to receive an engine,

providing an engine,

positioning the engine within the opening of the reservoir so that the engine partially is positioned within the reservoir, and the engine not being completely encapsulated by the reservoir, and

banding the engine that to the reservoir.

14. The method of claim 13, wherein banding the engine to the reservoir comprises printing the band, extrusion coating the band, screen coating the band, brush coating the band, spraying the band, or painting the band.

15. The method of claim 13, wherein banding the engine to the reservoir comprises a forming the band continuously around the dosage form in an area where the engine and reservoir come together.

16. The method of claim 13, wherein the band comprises material selected from the group consisting of polyethylene, polystyrene, ethylene-vinyl acetate copolymers, polycaprolactone and polyester based elastomers, polysaccharides, cellulosics, powdered cellulose, microcrystalline cellulose, cellulose acetate, cellulose acetate pseudolatex, cellulose acetate propionate, cellulose acetate butyrate, ethyl cellulose, ethyl cellulose pseudolatex, nitrocellulose, polylactic acid, poly-glycolic acid, polylactide glycolide copolymers, collagen, polycaprolactone, polyvinyl alcohol, polyvinyl acetate, polyethylene vinylacetate, polyethylene teraphthalate, polybutadiene styrene, polyisobutylene, polyisobutylene isoprene copolymer, polyvinyl chloride, polyvinylidene chloride-vinyl chloride copolymer, copolymers of acrylic acid and methacrylic acid esters, copolymers of methylmethacrylate and ethylacrylate, latex of acrylate esters, polypropylene, copolymers of propylene oxide and ethylene oxide, propylene oxide ethylene oxide block copolymers, ethylenevinyl alcohol copolymer, polysulfone, ethylene vinylalcohol copolymer, polyxylylenes, polyamides, natural and synthetic waxes, paraffin, carnauba wax, petroleum wax, white or yellow bees wax, castor wax, candelilla wax, rice bran wax, microcrystalline wax, stearyl alcohol, cetyl alcohol, bleached shellac, esterified shellac, chitin, chitosan, silicas, polyalkoxysilanes, polydimethyl siloxane, polyethylene glycol-silicone elastomers, crosslinked gelatin, zein, electromagnetic irradiation crosslinked acrylics, silicones, or polyesters, thermally crosslinked acrylics, silicones, or polyesters, butadiene-styrene rubber, glycerol ester of partially dimerized rosin, glycerol ester of partially hydrogenated wood rosin, glycerol ester of tall oil rosin, glycerol ester of wood rosin, pentaerythritol ester of partially hydrogenated wood rosin, pentaerythritol ester of wood rosin, natural or synthetic terpene resin and blends of the above.

17. The method of claim 13, wherein the band comprises a tape.

18. The method of claim 13, wherein the band comprises a preformed band.

19. The method of claim 13, further comprising loading an active agent formulation into the reservoir

20. The method of claim 13, further comprising

configuring the dosage form such that an exit orifice is included or formed in the reservoir to allow delivery of the active agent formulation.

21. The method of claim 13, wherein providing an engine comprises

providing an osmotic engine that comprises a rate controlling membrane

22. The method of claim 21, wherein the rate controlling membrane is formed or positioned over at least a portion of the osmotic engine that is not encapsulated by the reservoir.

23. The method of claim 21, wherein the controlling membrane is formed or positioned over both an exposed portion of the osmotic engine and the reservoir.

24. The method of claim 21, wherein the osmotic engine further comprises a barrier layer

25. The method of claim 24, further comprising:

orienting the osmotic engine before it is positioned within the reservoir such that after the engine is positioned within the opening of the reservoir, the barrier layer faces the active agent formulation.

26. The method of claim 24, wherein the barrier layer comprises a barrier layer that is resistant to permeation by the active agent formulation.