MULTIPLE UNIT DOSAGE FORM HAVING A THERAPEUTIC AGENT IN COMBINATION WITH A NUTRITIONAL SUPPLEMENT

• US 20100158956A1
• Filed: 12/22/2009
• Published: 06/24/2010
• Est. Priority Date: 06/26/2007
• Status: Active Grant

• Current Assignee: Bonafide Health LLC
• Original Assignee: JDS Therapeutics LLC
• Inventors: Komorowski, James R.
• Granted Patent: US 8,586,061 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/00 Medicinal preparations characterised by special physical form nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Compositions and methods for combination therapy are provided. The compositions comprise a multiple unit dosage form having both a therapeutic agent and a nutritional supplement. The combination therapy is useful for restoring a nutrient depletion associated with a particular disease state. Additionally, the combination therapy can prevent or attenuate the depletion of a nutrient caused, in whole or in part, by the co-administrated therapeutic drug. Methods of manufacturing the formulations are likewise described.

Claims

1. A multiple unit dosage form for oral administration comprising an effective amount of a therapeutic agent, a barrier layer, and a nutritional supplement, wherein said therapeutic agent and said nutritional supplement are formulated as a single dose.

2. The dosage form of claim 1, wherein said barrier layer is located between the therapeutic agent and said nutritional supplement and prevents interaction between said therapeutic agent and said nutritional supplement.

3. The dosage form of claim 1, wherein said barrier layer is comprised of a controlled-release, delayed-release, or enteric coating.

4. The dosage form of claim 1, wherein said therapeutic agent is located at the center of the form and the nutritional supplement is located at the outer portion of the form, and wherein the barrier layer separates the therapeutic agent from the nutritional supplement.

5. The dosage form of claim 1, wherein said nutritional supplement is located at the center of the form and the therapeutic agent is located at the outer portion of the form, and wherein the barrier layer separates the nutritional supplement from the therapeutic agent.

6. The dosage form of claim 1, wherein said therapeutic agent is selected from the group consisting of an antidepressant, an anti-thombotic, an anti-diabetic, an anti-psychotic, and a statin drug.

7. The dosage form of claim 1, wherein said nutritional supplement is selected from the group consisting of a vitamin, a mineral, an essential metal, and a co-enzyme.

8. The dosage form of claim 1, wherein said nutritional supplement is a chromium complex selected from the group consisting of chromium polynicotinate, chromium picolinate, chromium acetate, chromium histidinate, chromium nicotinate, chromium chloride, and chromium yeast.

9. The dosage form of claim 8, wherein said therapeutic is olanzapine.

10. The dosage form of claim 8, wherein said therapeutic is metformin.

11. The dosage form of claim 8, wherein said therapeutic is sertraline.

12. The dosage form of claim 8, wherein said therapeutic is tamoxifen.

13. The dosage form of claim 8, wherein said therapeutic is insulin.

14. The dosage form of claim 1, wherein said nutritional supplement is folic acid and said therapeutic is selected from the group consisting of an oral contraceptive, an H2 receptor antagonist, a non-steroidal anti-inflammatory drug, and metformin.

15. The dosage form of claim 1, wherein said nutritional supplement is zinc, and wherein said therapeutic is an angiotensin converting enzyme inhibitor (ACE inhibitor).

16. The dosage form of claim 1, wherein said nutritional supplement is vitamin B12 and said therapeutic is selected from the group consisting of metformin and a proton pump inhibitor.

17. The dosage form of claim 1, wherein said nutritional supplement is iron, and wherein said therapeutic is an H2 receptor antagonist.

18. The dosage form of claim 1, wherein said nutritional supplement is selenium, and wherein said therapeutic is an HIV therapeutic.

19. The dosage form of claim 1, wherein said nutritional supplement is carnitine, and wherein said therapeutic is an HIV therapeutic.

20. The dosage form of claim 1, wherein said therapeutic is a statin, and wherein said nutritional supplement is selected from the group consisting of chromium, niacin, and Co-enzyme Q10.

21. The dosage form of claim 1, wherein said therapeutic is a prostate cancer therapeutic and said nutritional supplement is selenium.

22. A method of preventing and/or attenuating depletion of a nutrient caused by the co-administration of a therapeutic agent to an individual in need thereof, comprising:

identifying an individual presenting with nutrient depletion associated with the administration of a therapeutic agent, administering to said individual the dosage form of claim 1, wherein said therapeutic agent causes or exacerbates nutrient depletion and wherein said nutritional supplement prevents and/or attenuates said depletion.

23. A method of synergistically treating a disease or condition caused or exacerbated by nutrient depletion comprising administering to an individual in need thereof the dosage form of claim 1.