IP Library › Granted Patent US 11,166,945
Granted Patent B2
US 11,166,945 · App. 16/886,093 · Granted Nov 9, 2021

Animal treatments

Inventors: David Rock (California, MO); Mark Ridall (Skillman, NJ)
Assignee: NewMarket Pharmaceuticals LLC
A61K31/4439A61K9/0053A61K31/135A61K31/137A61K31/155A61K31/341A61K31/403A61K31/4164A61K31/4174A61K31/44A61K31/5415A61K31/635A61K31/7048C07D307/52C07D401/12
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Quick Facts
Patent No.
US 11,166,945
App. No.
16/886,093
Granted
Nov 9, 2021
Kind
B2
Abstract

Compositions and methods for the treatment and control of various conditions in an animal which comprises administering to said animal an effective amount of a immediate release composition of about 0.5% to 50% wt/wt of active ingredient together with excipients to a total of about 100%, wherein said composition dissolves in a relatively short period of time, e.g., 75 seconds or less, 5 seconds or less, or 3 seconds or less, upon administration to said animal.

Claims (29)

1. A method of treating recurrent airway inflammation in an animal in need thereof, the method comprising:

determining a dose of clenbuterol required; and

administering orally to a pre-gastric mucosal cell of the animal a Direct Systemic Introduction (DSI) composition comprising clenbuterol,

wherein the DSI composition in the animal's oral cavity is dissolved in less than about 75 seconds, and

wherein the required dose of clenbuterol is determined by greater than 50% of the administered clenbuterol being detected in the animal's circulatory system via the pre-gastric mucosal cells lining the animal's alimentary canal prior to the animal's secretory stomach.

2. The method according to claim 1 , wherein the DSI composition is dissolved in less than about 30 seconds.

3. The method according to claim 1 , wherein the DSI composition is dissolved in less than about 5 seconds.

4. The method according to claim 1 , wherein the clenbuterol is present in the DSI composition in an amount ranging from about 0.5% to about 50% by weight of the overall composition.

5. The method according to claim 1 , wherein the clenbuterol is in the form of a free base; a water soluble salt; or an isolated single enantiomer or mixture thereof.

6. The method according to claim 1 , wherein the animal is human.

7. The method according to claim 1 , wherein the animal is an equine.

8. The method according to claim 1 , wherein the DSI composition further comprises at least one excipient.

9. The method according to claim 1 , wherein the DSI composition provides an immediate release of clenbuterol.

10. The method according to claim 1 , wherein the DSI composition is in the form of a tablet comprising about 0.36 mg of clenbuterol.

11. The method according to claim 1 , wherein the DSI composition is formulated to provide about 0.2 mcg/kg to about 3.0 mcg/kg of clenbuterol per body weight of the animal.

12. A method of treating a central nervous system disorder in an animal in need thereof, the method comprising:

determining a dose of clenbuterol required; and

administering orally to a pre-gastric mucosal cell of the animal a Direct Systemic Introduction (DSI) composition comprising clenbuterol,

wherein the DSI composition in the animal's oral cavity is dissolved in less than about 75 seconds, and

wherein the required dose of clenbuterol is determined by greater than 50% of the administered clenbuterol being detected in the animal's circulatory system via the pre-gastric mucosal cells lining the animal's alimentary canal prior to the animal's secretory stomach.

13. The method according to claim 12 , wherein the central nervous system disorder is Parkinson's Disease.

14. The method according to claim 12 , wherein the DSI composition is dissolved in less than about 30 seconds.

15. The method according to claim 12 , wherein the DSI composition is dissolved in less than about 5 seconds.

16. The method according to claim 12 , wherein the clenbuterol is present in the DSI composition in an amount ranging from about 0.5% to about 50% by weight of the overall composition.

17. The method according to claim 12 , wherein the clenbuterol is in the form of a free base; a water soluble salt; or an isolated single enantiomer or mixture thereof.

18. The method according to claim 12 , wherein the animal is human.

19. The method according to claim 12 , wherein the animal is an equine.

20. The method according to claim 12 , wherein the DSI composition further comprises at least one excipient.

21. The method according to claim 12 , wherein the DSI composition provides an immediate release of clenbuterol.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2020
From: ROCK, DAVID; RIDALL, MARK
To: NEWMARKET PHARMACEUTICALS LLC
Reel/Frame 052783/0920 →
Continuity (5)
Continuation 16014290 · Jun 21, 2018
Continuation 14275019 · May 12, 2014
Continuation 13343692 · Jan 4, 2012
Provisional Application 61437763 · Jan 31, 2011
Related Publication 20200289487A1 · Sep 17, 2020
Cited By (1)
US 12,496,295