Dosage forms and related therapies

• US 9,339,479 B2
• Filed: 12/17/2014
• Issued: 05/17/2016
• Est. Priority Date: 08/20/2002
• Status: Active Grant

• Current Assignee: Philera New Zealand Limited
• Original Assignee: Philera New Zealand Limited
• Inventors: Cooper, Garth James Smith
• Primary Examiner(s): PACKARD, BENJAMIN J
• Application Number:
  US14/573,211
• Publication Number:
  US 20150164826A1
• Time in Patent Office: 517 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/131 acyclic
• CPC Class Codes: A61K 31/132 having two or more amino groups, e.g. spermidine, putrescine
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/30 Copper compounds
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 39/04 Chelating agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

This invention is directed in part to novel doses, dosage formulations, and routes of administration of such doses and dose formulations, said dose and dose formulations containing one or more copper chelators, for example, one or more trientine active agents, including trientine analogs, trientine salts, trientine prodrugs, and trientine derivatives, useful in the treatment of diseases, disorders and conditions, including in indications where copper may play a role.

Claims

1. A composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a succinic acid addition salt of triethylenetetramine.

2. The composition of claim 1 comprising from 50 mg to 500 mg of the succinic acid addition salt of triethylenetetramine.

3. The composition of claim 1 comprising from 110 to 290 mg of the succinic acid addition salt of triethylenetetramine.

4. The composition of claim 1 comprising from 130 to 270 mg of the succinic acid addition salt of triethylenetetramine.

5. The composition of claim 1 comprising from 140 to 260 mg of the succinic acid addition salt of triethylenetetramine.

6. The composition of claim 1 comprising from 180 to 220 mg of the succinic acid addition salt of triethylenetetramine.

7. The composition of claim 1 comprising from 50 mg to 100 mg of the succinic acid addition salt of triethylenetetramine.

8. The composition of claim 1 wherein the amount of the succinic acid addition salt of triethylenetetramine is selected from the group consisting of 50 mg, 110 mg, about 130 mg, 140 mg, and 150 mg.

9. The composition of claim 1 wherein the amount of the succinic acid addition salt of triethylenetetramine is selected from the group consisting of 1.2 mg, 10 mg, 12 mg, 20 mg, 30 mg, and 40 mg.

10. The composition of claim 1, wherein the succinic acid addition salt of triethylenetetramine is prepared using an acid which yields a physiologically acceptable salt.

11. The composition of claim 1, wherein said composition is in a form suitable for oral administration.

12. The composition of claim 11, wherein said form suitable for oral administration is a capsule.

13. The composition of claim 11, wherein said form suitable for oral administration is a tablet.

14. The composition of claim 13, wherein said tablet is an enteric-coated tablet or a layered tablet.

15. The composition of claim 11, wherein said form suitable for oral administration is a sustained release preparation, a delayed release preparation, a slow release preparation, a controlled release preparation, or an extended release preparation.

16. The composition of claim 11, wherein said composition is in a form suitable for transdermal administration.

17. The composition claim 1, wherein said composition is in a form suitable for transmucosal administration.

18. The composition of claim 1, wherein said composition is in a form suitable for administration as a suppository.