PHARMACEUTICAL PRODUCT

• US 20090155315A1
• Filed: 11/18/2005
• Published: 06/18/2009
• Est. Priority Date: 11/19/2004
• Status: Active Grant

• Current Assignee: GlaxoSmithKline LLC (GSK plc)
• Original Assignee: Smithkline Beecham Corporation (GSK plc)
• Inventors: Glinecke, Robert, Finkelmeier, Steven D., Martini, Luigi
• Granted Patent: US 8,858,960 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61J 3/06 into the form of pills, lozenges or dragees
• CPC Class Codes: A61J 3/10 into the form of compressed tablets tablet presses B30B11/00
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00

Abstract

A pharmaceutical and pharmaceutical-like product is provided. The product provides a plurality of components having active agents that are delivered in a single delivery entity or vehicle. The product allows for selective control of the release rates of each of the active agents while still being delivered in a single product.

Claims

1. A pharmaceutical product comprising:

a plurality of solid components, wherein at least two of said plurality of solid components have active agents, the pharmaceutical product being produced by a process of independently forming said plurality of solid components by compression molding and assembling said plurality of solid components into a single delivery vehicle.

2. The product of claim 1, wherein at least one of said plurality of solid components has a sealing coat on a portion thereof.

3. The product of claim 1, wherein said plurality of solid components are interlocked via a mechanical connection.

4. The product of claim 3, wherein said mechanical connection is a rivet.

5. The product of claim 1, wherein said plurality of solid components are interlocked via a connection selected from the group consisting essentially of a rivet, a locking pin mechanism, a snap-fit, a screw-fit, a pressure sensitive compression, an injection molded locking pin, banding, shrink wrapping, injection mold gluing, ultrasonic welding, lasers, microwaves, heat, friction welding, and any combinations thereof.

6. The product of claim 1, wherein said plurality of solid components are interlocked via a connection using a material selected from the group consisting essentially of PEG, HPMC, gelatin, starch, gum, chicle, latex sap from the sapodilla tree, natural rubber, gum base, natural resin, sorva, jelutong, wax, cheese wax, chewing gum wax, butyl, polyisobutylene rubber, beeswax, carnauba wax, microcrystalline wax, food grade adhesive, sugar-based edible adhesive, envelope grade adhesive, printed ink, shellac, hot melt food grade glue, epoxy, opadry overcoat, dental adhesive, quick dissolving film, heat sensitive film, water, alcohol, and any combinations thereof.

7. The product of claim 1, wherein at least one of said plurality of solid components does not have an active agent.

8. The product of claim 1, wherein said plurality of solid components are interlocked via a mechanical connection and an adhesive.

9. The product of claim 1, wherein at least one of said plurality of solid components is enclosed when the single delivery vehicle is assembled.

10. The product of claim 1, wherein a first of said plurality of solid components is isolated from a second of said plurality of solid components by a third of said plurality of solid components when the single delivery vehicle is assembled.

11. The product of claim 1, wherein all of said plurality of solid components are exposed when the single delivery vehicle is assembled.

18. The product according to claim 1, wherein said plurality of solid components are connected using an adhesive.

19. The product according to claim 18, wherein the adhesive is a functional coating.

20. The product according to claim 19, wherein the functional coating is an overcoating of a core matrix with a methylcellulose/hypromellose polymeric derivative.

22. The product according to claim 20, wherein the methylcellulose/hypromellose polymeric derivative is wetted with water or a water:

alcohol solution.

23. The product of according to claim 1, wherein said plurality of solid components are three solid components, and wherein the three solid components are an upper component, a lower component, and a middle component between the upper and lower components.

24. The product of according to claim 23, wherein the middle component is narrower than the upper and lower components so that an interlocking interface is formed amongst the upper, middle and lower components when formed together.

25. The product of according to claim 23, wherein the upper component and the lower component each have a recess, and wherein the recesses conform to the shape of the middle component.

26. The product of according to claim 23, wherein the middle component has a shape selected from the group consisting of oval, round, and rectangular.

12. A method of producing a pharmaceutical product, the method comprising:

independently forming a plurality of solid components via compression molding, wherein at least two of said plurality of solid components have active agents; and

assembling said plurality of solid components into a single delivery vehicle.

13. The method of claim 12, further comprising coating at least one of said plurality of solid components.

14. The method of claim 12, wherein said plurality of solid components are interlocked via a mechanical connection.

15. The method of claim 12, wherein said plurality of solid components are interlocked via a connection selected from the group consisting essentially of a rivet, locking pin mechanism, a snap-fit, a screw-fit, a pressure sensitive compression, an injection molded locking pin, banding, shrink wrapping, injection mold gluing, ultrasonic welding, lasers, microwaves, heat, friction welding, and any combinations thereof.

16. The method of claim 12, wherein said plurality of solid components are interlocked via a connection using a material selected from the group consisting essentially of PEG, HPMC, gelatin, starch, gum, chicle, latex sap from the sapodilla tree, natural rubber, gum base, natural resin, sorva, jelutong, wax, cheese wax, chewing gum wax, butyl, polyisobutylene rubber, beeswax, carnauba wax, microcrystalline wax, food grade adhesive, sugar-based edible adhesive, envelope grade adhesive, printed ink, shellac, hot melt food grade glue, epoxy, opadry overcoat, dental adhesive, quick dissolving film, heat sensitive film, and any combinations thereof.

17. The product or method of producing a pharmaceutical product as herein before described with reference to anyone of FIGS. 1 through 99 of the accompanying drawings.

21. (canceled)