Method of treating frailty

• US 10,543,217 B2
• Filed: 08/23/2010
• Issued: 01/28/2020
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: OrgaNext Research B.V.
• Original Assignee: OrgaNext Research B.V.
• Inventors: Prins, Marjanna, Kloosterboer, Helenius Jan
• Primary Examiner(s): Qazi, Sabiha N
• Application Number:
  US13/318,650
• Publication Number:
  US 20120196837A1
• Time in Patent Office: 3,445 Days
• Field of Search: 514167
• 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 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/592 9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 21/06 Anabolic agents androgens A61P5/26
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Disclosed is a method of treatment or prevention of frailty in an elderly patient, particularly having an age of 60 or older. The method provides the concomitant parenteral administration of a combination of an anabolic steroid and a vitamin D compound. A preferred combination comprises nandrolone decanoate and cholecalciferol (vitamin D₃). The invention, in a further preference, provides a booster therapy to support frail elderly that have undergone hospitalization or surgery to retain independence and regain their regular physical and mental activities.

Claims

1. A pharmaceutical composition which contains 5 mg to 50 mg nandrolone decanoate, and 17.5 μ

g to 15 mg of cholecalciferol consisting of;

(i) active substances consisting of nandrolone decanoate and cholecalciferol in a molar ratio of 100;

1 to 1;

1; and

(ii) a carrier liquid suitable for parenteral administration

wherein the molar ratio of nandrolone decanoate and cholecalciferol results in a synergistic increase in muscle mass in a subject when said composition is administered to said subject.

2. The pharmaceutical composition according to claim 1, wherein the carrier liquid is selected from the group consisting of arachis oil, cottonseed oil, and sesame oil.

3. The pharmaceutical composition according to claim 1, wherein the carrier liquid is an oil.

4. The pharmaceutical composition according to claim 1, wherein the carrier liquid is suitable for subcutaneous administration.

5. A method of treatment of frailty in an elderly patient comprising administering the pharmaceutical composition of claim 1.

6. The method according to claim 5, wherein the administering is done at least monthly.

7. The method according to claim 5, wherein the administering is done for a period of at least 3 months.

8. The method according to claim 5, wherein the patient has an age of 60 or older.

9. The method according to claim 6, wherein the administering is done at least weekly.

10. The method according to claim 7, wherein the administering is done for a period of 3 to 12 months.

11. The method according to claim 8, wherein the patient has an age of 65 or older.

12. The method according to claim 5 wherein said treatment increases muscle mass.