Apparatus and methodology for pulsed administration of growth promoting agents

• US 4,747,825 A
• Filed: 06/29/1984
• Issued: 05/31/1988
• Est. Priority Date: 06/29/1984
• Status: Expired due to Term

• Current Assignee: Ferring Pharmaceuticals Incorporated (Ferring Holding SA)
• Original Assignee: Ferring Laboratories, Inc.
• Inventors: Linkie, Daniel M., Thorner, Michael O.
• Primary Examiner(s): Dixon, Jr., William R.
• Assistant Examiner(s): Medley, Margaret B.
• Application Number:
  US06/626,400
• Time in Patent Office: 1,432 Days
• Field of Search: 604/51, 604/49, 604/151, 604/890, 604/891
• US Class Current: 604/522
• CPC Class Codes: A61K 38/25 Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y10S 930/12 Growth hormone, growth factor other than t-cell or b-cell growth factor, and growth hormone releasing factor; related peptides

Abstract

A method and apparatus for therapeutically effective treatment of a living animal comprising administering a dynamic dosage of growth hormone releasing factor or analog thereof, or administering growth hormone or analogs thereof in a chronic course of treatment in a subdesensitizing regimen. Also a method of diagnosing living animals with an anterior pituitary unresponsive to growth hormone releasing factor or analogs thereof. A method of determining the optimum GRF and GH dynamic dosage for a given living animal, particularly a human.

Claims

1. A method of therapeutically effective treatment of a living animal comprising administering to the animal a dynamic dosage of growth hormone releasing factor, analogs, biologically active fragments and derivatives thereof (collectively GRF) said dynamic dosage comprising administration of GRF to be interrupted by periods of non-administration of GFR of from at least about 2 times the half-life of GRF in the blood.

2. The method of claim 1 wherein the period of non-administration of GRF is at least about 3 times the half life of GFR in the blood.

3. The method of claim 1 wherein the GRF is administered subcutaneously.

4. The method of claim 1 wherein the GRF is administered chronically for a period in excess of 5 days.

5. The method of claim 1 wherein the animal is a human.

6. The method of claim 1 wherein the dynamic dosage per introduction is from about 0.1 to 10 micrograms per kilogram of body weight.

7. The method of claim 6 wherein the dynamic dosage is from 1 microgram to 3.3 micrograms per kilogram.

8. The method of claim 6 wherein the GRF is norleucine²⁷ hpGRF(1-29)-NH₂.

9. The method of claim 1 wherein the dynamic dosage is administered by intermittent infusion pump.

10. A method of therapeutically effective treatment of a living animal comprising administering to the animal a dynamic dosage of growth hormone releasing factor, analogs, biologically active fragments and derivatives thereof (collectively GRF) said dynamic dosage comprising administration of GRF from about every half hour to about every 5 hours.

11. The method of claim 10 wherein the administration of GRF is from about every two and one-half hours to about every three and one-half hours.

12. The method of claim 10 wherein the GRF is administered subcutaneously.

13. The method of claim 10 wherein the GRF is administered chronically for a period in excess of 5 days.

14. The method of claim 10 wherein the animal is a human.

15. The method of claim 10 wherein the dynamic dosage per introduction is from 0.1 to 10 micrograms per kilogram of body weight.

16. The method of claim 15 wherein the dynamic dosage is from 1 microgram to 3.3 micrograms per kilogram.

17. The method of claim 10 wherein the dynamic dosage per introduction is from 0.1 to 10 micrograms per kilogram body weight.

18. The method of claim 17 wherein the dynamic dosage is from 1 microgram to 3.3 micrograms per kilogram.

19. The method of claim 14 wherein the GRF is norleucine²⁷ hpGRF(1-29)-NH₂.

20. The method of claim 14 wherein the administration of GRF is from about every two and one-half hours to about every three and one-half hours.

21. The method of claim 20 wherein the dynamic dosage per introduction is from 0.1 to 10 micrograms per kilogram of body weight.

22. The method of claim 21 wherein the GRF is administered subcutaneously chronically for a period in excess of five days by intermittent infusion pump.

23. The method of claim 22 wherein the GRF is norleucine²⁷ hpGRF(1-29)-NH₂.

24. The method of claim 10 wherein the dynamic dosage is administered by intermittent infusion pump.

25. A method of therapeutically effective treatment of a living animal comprising administering to the animal a dynamic dosage of growth hormone, analogs, biologically active fragments and derivatives thereof (collectively GH) said dynamic dosage comprising administration of GH to be interrupted by periods of non-administration of GH of from at least about two times the half-life of GH in the blood.

26. The method of claim 25 wherein the GH is administered chronically for a period in excess of 5 days.

27. The method of claim 25 wherein the dynamic dosage is administered by intermittent infusion pump.

28. A method of therapeutically effective treatment of a living animal comprising administering to the animal a dynamic dosage of growth hormone, analogs, biologically active fragments and derivatives thereof (collectively GH) said dynamic dosage comprising administration of GH about every half hour to about every 5 hours.

29. The method of claim 28 wherein the dynamic dosage is administered by intermittent infusion pump.

30. A method of diagnosing in a living animal growth retardation due to the inability of the pituitary to respond to a dynamic dosage of growth hormone releasing factor, analogs, biologically active fragments and derivatives thereof (collectively GRF) wherein the dynamic dosage of GRF comprises administration of GRF from about every half hour to about every 5 hours the method comprising administering said dynamic dosage and measuring the response thereto.