Metering and packaging of controlled release medication

• US 7,404,968 B2
• Filed: 01/12/2004
• Issued: 07/29/2008
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Original Assignee: Microdose Technologies Inc. (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Gumaste, Anand V., Abrams, Andrew L.
• Primary Examiner(s): TRAN, SUSAN T
• Application Number:
  US10/756,124
• Publication Number:
  US 20040142036A1
• Time in Patent Office: 1,660 Days
• Field of Search: 424/451, 424/452, 424/453, 424/457, 424/464, 424/465, 424/468, 424/471
• US Class Current: 424/443
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• 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

Controlled quantities of powdered medication are formed in controlled release packages using electrostating metering. Also provided are combination medication therapy delivery packages comprising two or more active pharmaceuticals segregated from one another in a single delivery package.

Claims

1. A pharmaceutical delivery package consisting of fixed unit dose quantities of two or more different powdered pharmaceutical ingredients, wherein said pharmaceutical ingredients are selected from the group consisting of a mixture of Ketoconazole and testosterone, a mixture of Valacylovir and Cimetidine, a mixture of Valacylovir and Probenecid, a mixture of Valacylovir, Cimetidine and Probenecid, a mixture of Enalapril and a beta-adrenergic blocking agent, methyldopa, nitrate, a calcium blocking agent, hydrazinc, Prazosin or Digoxin, a mixture of Omeprazole and B12, a mixture of Tamoxifen and a diuretic, a mixture of Isotretinoin and an oral contraceptive, and a mixture of Metformin HCl and Sulfonylurea, separated from one another on an ingestible membrane which forms a single delivery package, wherein said ingestible membrane has selected permeability porosity to fluids for controlled release of said powdered pharmaceutical ingredients at two or more different selected sites within the stomach or intestines of a patient'"'"'s alimentary canal, further comprising a mucosal adhesive layer on an outer surface of the membrane.

2. A pharmaceutical delivery package according to claim 1, wherein the adhesive is acid or alkaline activatable.

3. A pharmaceutical delivery package according to claim 1, and further comprising an alkali or acid dissolvable membrane covering the adhesive.

4. A pharmaceutical delivery package according to claim 1, wherein said membrane comprises a material which expands upon contact with acid or alkaline in the alimentary canal, whereby to become more porous.

5. A pharmaceutical delivery package according to claim 1, wherein said membrane is formed into a tablet or capsule.

6. A pharmaceutical delivery package according to claim 1, wherein said powdered pharmaceutical ingredients are segregated from one another in a compartmentalized capsule.

7. A pharmaceutical delivery package according to claim 1, wherein said powdered pharmaceutical ingredients are segregated from one another in a tablet.

8. A pharmaceutical delivery package according to claim 1, wherein said powdered pharmaceutical ingredients are encapsulated within inert coatings.

15. A pharmaceutical delivery package according to claim 1, wherein said ingestible membrane comprises an alkali-dissolvable or acid-dissolvable material.

9. A controlled release pharmaceutical delivery package consisting of fixed unit dose quantities of two or more different powdered pharmaceutical ingredients combined in a single delivery package, wherein said delivery package comprises an ingestible membrane, and said two or more different powdered pharmaceutical ingredients comprise combinations of active pharmaceutical ingredients selected from the group consisting of (a) mixture of Ketoconazole and testosterone, (b) a mixture of Valacylovir and one or both of Cimetidine and Probenecid, (c) a mixture of Enalapril and a beta-adrenergic blocking agent, methyldopa, nitrate, a calcium blocking agent, hydrazinc, Prazosin or Digoxin, (d) a mixture of Omeprazole and B12, (e) mixture of Tamoxifen and a diuretic, (f) a mixture of Isotretinoin and an oral contraceptive, and (g) a mixture of Metformin HCl and Sulfonylurea, further comprising an adhesive on an outer surface of the membrane.

10. A pharmaceutical delivery package according to claim 9, wherein said ingestible membrane comprises an alkali-dissolvable or acid-dissolvable material.

16. A pharmaceutical delivery package according to claim 9, wherein said membrane is formed into a tablet or capsule.

17. A pharmaceutical delivery package according to claim 9, wherein said powdered pharmaceutical ingredients are segregated from one another in a compartmentalized capsule.

11. A pharmaceutical delivery package consisting of fixed unit dose quantities of two or more different powdered pharmaceutical ingredients separated from one another on an ingestible membrane which forms a single delivery package, wherein said ingestible membrane has selected permeability porosity to fluids for controlled release of said powdered pharmaceutical ingredients at a selected site or sites within a patient'"'"'s alimentary canal,

wherein said two or more powdered pharmaceutical ingredients are deposited on said membrane, separated from one another by one or more barriers or membranes, and wherein said two or more powdered pharmaceutical ingredients are selected from the group consisting of (a) a mixture of Ketoconazole and testosterone, (b) a mixture of Valacylovir and one or both of Cimetidine and Probenecid, (c) a mixture of Enalapril and a beta-adrenergic blocking agent, methyldopa, nitrate, a calcium blocking agent, hydrazinc, Prazosin or Digoxin, (d) a mixture of Omeprazole, and B12, (e) a mixture of Tamoxifen and a diuretic, (f) a mixture of Isotretinoin and an oral contraceptive, and (g) a mixture of Metformin HCl and Sulfonylurea.

13. A pharmaceutical delivery package according to claim 11, wherein said ingestible membrane comprises an alkali-dissolvable or acid-dissolvable material.

18. A pharmaceutical delivery package according to claim 11, wherein said membrane is formed into a tablet or capsule.

19. A pharmaceutical delivery package according to claim 11, wherein said powdered pharmaceutical ingredients are segregated from one another in a compartmentalized capsule.

12. A pharmaceutical delivery package consisting of fixed unit dose quantities of two or more different powdered pharmaceutical ingredients separated from one another on an ingestible membrane which forms a single delivery package, wherein said ingestible membrane has selected permeability porosity to fluids for controlled release of said powdered pharmaceutical ingredients at two or more different selected sites within a patient'"'"'s alimentary canal,

wherein said two or more powdered pharmaceutical ingredients are deposited on said membrane, separated from one another by one or more bafflers or membranes, and wherein said two or more powdered pharmaceutical ingredients are selected from the group consisting of Ketoconazole and testosterone;

Valacylovir and one or both of Cimetidine and Probenecid;

Enalapril and a beta-adrenergic blocking agent, methyldopa, nitrate, a calcium blocking agent, hydrazinc, Prazosin or Digoxin;

Omeprazole and B12;

Tamoxifen and a diuretic;

Isotretinoin and an oral contraceptive; and

Metformin HCl and Sulfonylurea.

14. A pharmaceutical delivery package according to claim 12, wherein said ingestible membrane comprises an alkali-dissolvable or acid-dissolvable material.

20. A pharmaceutical delivery package according to claim 12, wherein said membrane is formed into a tablet or capsule.

21. A pharmaceutical delivery package according to claim 12, wherein said powdered pharmaceutical ingredients are segregated from one another in a compartmentalized capsule.