IP Library Granted Patent US 9,452,132
Granted Patent B2
US 9,452,132 · App. 14/812,993 · Granted Sep 27, 2016

Methods for administration and formulations for the treatment of regional adipose tissue

Inventors: John Daniel Dobak (La Jolla, CA); Kenneth Walter Locke (Carlsbad, CA)
Assignee: NEOTHETICS, INC.
A61K9/0019A61K31/137A61K31/167A61K31/56A61K31/568A61K31/573A61K31/58
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Quick Facts
Patent No.
US 9,452,132
App. No.
14/812,993
Granted
Sep 27, 2016
Kind
B2
Abstract

Provided herein are pharmaceutical formulations, methods, and systems for treating regional fat deposits and fat-related conditions and indications. Methods comprise administering a pharmaceutical formulation comprising a long-acting beta-2 adrenergic receptor agonist, for example, salmeterol, suitable for subcutaneous administration. Formulations comprise a pharmaceutical formulation that is suitable for subcutaneous injection comprising: (a) a lipophilic long-acting selective beta-2 adrenergic receptor agonist, or a salt thereof; and (b) at least one subcutaneously acceptable inactive ingredient.

Claims (23)

1. An aqueous formulation comprising a non-sustained release formulation suitable for subcutaneous injection that comprises:

(a) an adipose tissue-reducing lipophilic long-acting selective beta-2 adrenergic receptor agonist or a salt thereof, that comprises a dose of up to about 2 micrograms of the agonist and that is suitable for subcutaneous injection; and

(b) at least one subcutaneously acceptable inactive ingredient.

2. The formulation of claim 1 wherein the formulation is formulated as a dose of up to about 1 microgram of the beta-2 adrenergic receptor agonist.

3. The formulation of claim 1 wherein the formulation is formulated as a dose of up to about 500 nanograms of the beta-2 adrenergic receptor agonist.

4. The formulation of claim 1 wherein the formulation is formulated as a dose of up to about 20 nanograms of the beta-2 adrenergic receptor agonist.

5. The formulation of claim 1 wherein the formulation is formulated to be administered using a single needle, multiple needles, or a needleless injection device.

6. The formulation of claim 1 wherein the dose of the beta-2 adrenergic receptor agonist is formulated to be administered through at least 2 sub-doses.

7. The formulation of claim 1 wherein the dose of the beta-2 adrenergic receptor agonist is formulated to be administered through at least 10 sub-doses.

8. The formulation of claim 1 wherein the lipophilic long-acting selective beta-2 adrenergic receptor agonist is salmeterol xinafoate.

9. The formulation of claim 8 wherein the dose of salmeterol xinafoate is formulated to be administered through at least 2 sub-doses.

10. The formulation of claim 9 wherein a single sub-dose comprises about 20 nanograms of salmeterol xinafoate.

11. A method of treating a patient who has excess adipose tissue or reducing adipose tissue in a patient comprising subcutaneously administering to said patient a non-sustained release pharmaceutical formulation that is suitable for subcutaneous injection, the formulation comprising:

(a) an adipose tissue-reducing lipophilic long-acting selective beta-2 adrenergic receptor agonist or a salt thereof, that comprises a dose of up to about 2 micrograms of the agonist; and

(b) at least one subcutaneously acceptable inactive ingredient.

12. The method of claim 11 wherein the formulation is administered as a dose of up to about 1 microgram of the beta-2 adrenergic receptor agonist.

13. The method of claim 11 wherein the formulation is administered as a dose of up to about 500 nanograms of the beta-2 adrenergic receptor agonist.

14. The method of claim 11 wherein the dose of the beta-2 adrenergic receptor agonist is administered through at least 2 sub-doses.

15. The method of claim 11 wherein the lipophilic long-acting selective beta-2 adrenergic receptor agonist is salmeterol xinafoate.

16. The method of claim 15 wherein the dose of salmeterol xinafoate is administered through at least 10 sub-doses.

17. The method of claim 16 wherein a single sub-dose comprises up to about 50 nanograms of salmeterol xinafoate.

18. The method of claim 11 , wherein the method is a method of treating a patient who has excess adipose tissue.

19. The method of claim 11 , wherein the method is a method of reducing adipose tissue in a patient.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2015
From: DOBAK, JOHN DANIEL; LOCKE, KENNETH WALTER
To: NEOTHETICS, INC.
Reel/Frame 036217/0350 →
Continuity (5)
Continuation 12788190 · May 26, 2010
Provisional Application 61181627 · May 27, 2009
Provisional Application 61251624 · Oct 14, 2009
Provisional Application 61289972 · Dec 23, 2009
Related Publication 20150328146A1 · Nov 19, 2015