.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 8,431,549

« Back to Dashboard

Details for Patent: 8,431,549

Title:Methods and compositions for administration of iron
Abstract: The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
Inventor(s): Helenek; Mary Jane (Brookville, NY), Tokars; Marc L. (Douglassville, PA), Lawrence; Richard P. (Calverton, NY)
Assignee: Luitpold Pharmaceuticals, Inc. (Shirley, NY)
Filing Date:May 25, 2010
Application Number:12/787,283
Claims:1. A method of treating a disease, disorder, or condition characterized by iron deficiency or dysfunctional iron metabolism resulting in reduced bioavailability of dietary iron, comprising administering to a subject in need thereof an iron carbohydrate complex in a single dosage unit of at least about 0.6 grams of elemental iron, wherein, the iron carbohydrate complex is selected from the group consisting of an iron mannitol complex, and an iron polyisomaltose complex, an iron polymaltose complex, an iron gluconate complex, and an iron sorbitol complex, the iron carbohydrate complex has a substantially non-immunogenic carbohydrate component, and the disease, disorder or condition is not Restless Leg Syndrome.

2. The method of claim 1, wherein the iron carbohydrate complex has substantially no cross reactivity with anti-dextran antibodies.

3. The method of claim 1, wherein the disease, disorder, or condition comprises anemia.

4. The method of claim 3, wherein the anemia comprises iron deficiency anemia.

5. The method of claim 3, wherein: (i) the anemia comprises an iron deficiency anemia associated with chronic blood loss; acute blood loss; pregnancy; childbirth; childhood development; psychomotor and cognitive development in children; breath holding spells; heavy uterine bleeding; menstruation; chronic recurrent hemoptysis; idiopathic pulmonary siderosis; chronic internal bleeding; gastrointestinal bleeding; parasitic infections; chronic kidney disease; dialysis; surgery or acute trauma; and chronic ingestion of alcohol, chronic ingestion of salicylates, chronic ingestion of steroids; chronic ingestion of non-steroidal anti-inflammatory agents, or chronic ingestion of erythropoiesis stimulating agents; (ii) the anemia is of a chronic disease selected from the group consisting of rheumatoid arthritis; cancer; Hodgkins leukemia; non-Hodgkins leukemia; cancer chemotherapy; inflammatory bowel disease; ulcerative colitis thyroiditis; hepatitis; systemic lupus erythematosus; polymyalgia rheumatica; scleroderma; mixed connective tissue disease; Sojgren's syndrome; congestive heart failure/cardiomyopathy; and idiopathic geriatric anemia; (iii) the anemia is due to impaired iron absorption or poor nutrition; (iv) the anemia is associated with Crohn's Disease; gastric surgery; ingestion of drug products that inhibit iron absorption; or chronic use of calcium.

6. The method of claim 1 wherein the disease, disorder, or condition is selected from the group consisting of blood donation; hair loss; and attention deficit disorder.

7. The method of claim 1 wherein the single dosage unit of elemental iron is at least about 1.0 grams.

8. The method of claim 1 wherein the single dosage unit of elemental iron is at least about 1.5 grams.

9. The method of claim 1 wherein the single dosage unit of elemental iron is at least about 2.0 grams.

10. The method of claim 1 wherein the single dosage unit of elemental iron is administered in about 15 minutes or less.

11. The method of claim 1 wherein the single dosage unit of elemental iron is administered in about 5 minutes or less.

12. The method of claim 1, wherein the iron carbohydrate complex is an iron polyglucose sorbitol carboxymethyl ether complex.

13. The method of claim 12, wherein the iron polyglucose sorbitol carboxymethyl ether complex is a polyglucose sorbitol carboxymethyl ether-coated non-stoichiometric magnetite complex.

14. The method of claim 1, wherein mean iron core size is at least about 1 nm but no greater than about 9 nm; or mean size of a particle of the iron carbohydrate complex is no greater than about 35 nm.

15. The method of claim 1, wherein the iron carbohydrate complex is administered parenterally.

16. The method of claim 15, wherein (i) parenteral administration comprises intravenous infusion and the single unit dose of iron carbohydrate complex is administered at a concentration of about 1000 mg elemental iron in about 200 ml to about 300 ml of diluent; (ii) parenteral administration comprises bolus injection and the single unit dose of iron carbohydrate complex is administered at a concentration of about 1000 mg elemental iron in about 200 ml to about 300 ml of diluent; or (iii) parenteral administration comprises intramuscular injection and the single unit dose of iron carbohydrate complex is administered at a concentration of about 500mg elemental iron in less than about 10 ml diluent.

17. The method of claim 1 further comprising a second administration of said iron carbohydrate complex upon recurrence of at least one symptom of the disease, disorder, or condition.

18. The method of claim 1 wherein the single dosage unit of elemental iron is administered in about 2 minutes or less.

19. The method of claim 1 wherein the single dosage unit of elemental iron is greater than 1.0 grams.

20. The method of claim 1 wherein the iron carbohydrate complex is an iron mannitol complex.

21. The method of claim 1 wherein the iron carbohydrate complex is an iron polyisomaltose complex.

22. The method of claim 1 wherein the iron carbohydrate complex is an iron gluconate complex.

23. The method of claim 1 wherein the iron carbohydrate complex is an iron sorbitol complex.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc