Method of producing a concentrate comprising a sulfonamide in solution, a 2,4-diaminopyrimidine in stable suspension within said solution

• US 6,410,543 B1
• Filed: 02/12/2001
• Issued: 06/25/2002
• Est. Priority Date: 05/05/1999
• Status: Expired due to Term

• Current Assignee: Pharmaceutical Solutions Incorporated
• Original Assignee: Pharmaceutical Solutions Incorporated
• Inventors: Strobel, Michael A., Soderlund, William A. Jr.
• Primary Examiner(s): Weddington, Kevin E.
• Application Number:
  US09/780,371
• Time in Patent Office: 498 Days
• Field of Search: 514/256, 514/260, 514/601
• US Class Current: 514/256
• 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 31/18 Sulfonamides compounds containing a para-N-benzene-sulfonyl-N- group A61K31/63
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim

Abstract

A palatable antimicrobial drug concentrate comprising: (a) a sulfonamide and/or sulfonamide salt in aqueous solution; (b) a 2,4-diaminopyrimidine in stable suspension within said solution; and (c) a suspending agent. The invention has a long room temperature shelf life and is sufficiently stable to be administered via the drinking water of animals.

Claims

1. A method of producing a palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water, comprising the following steps:

a) preparing a mixture of an antioxidant, a base, a pharmaceutically acceptable surfactant, a sweetener, and a flavoring agent in solution;

b) stirring until the mixture is dissolved;

c) adding a sulfonamide to the solution

d) stirring and dissolving the sulfonamide;

e) adding an antimicrobial agent to the solution; and

f) stirring the solution sufficient enough to suspend the antimicrobial agent.

2. The method according to claim 1 further comprising the step of adding a suspending agent into the solution after adding the antimicrobial agent.

3. The method according to claim 2 further comprising the step of stirring the solution until the suspending agent is hydrated and the antimicrobial agent is sufficiently coated.

4. The method according to claim 3 further comprising the steps of diluting the solution with deionized water, and filtering the solution prior to adding the antimicrobial agent to the solution.

5. The method according to claim 3 further comprising the step of diluting the solution after the suspending agent is hydrated and the antimicrobial agent is sufficiently coated.

6. The method according to claim 5 wherein the antimicrobial agent has a particle size of 1 μ

to 100μ

.

7. A palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water, prepared by a process comprising the steps of:

a) preparing a mixture of an antioxidant, a base, a pharmaceutically acceptable surfactant, a sweetener, and a flavoring agent in solution;

b) stirring until the mixture is dissolved;

c) adding a sulfonamide to the solution

d) stirring and dissolving the sulfonamide;

e) adding an antimicrobial agent to the solution; and

f) stirring the solution sufficient enough to suspend the antimicrobial agent.

8. The palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water produced by the method according to claim 7 further comprising the step of adding a suspending agent into the solution after adding the antimicrobial agent.

9. The palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water produced by the method according to claim 8 further comprising the step of stirring the solution until the suspending agent is hydrated and the antimicrobial agent is sufficiently coated.

10. The palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water produced by the method according to claim 9 further comprising the steps of diluting the solution with deionized water, and filtering the solution prior to adding the antimicrobial agent to the solution.

11. The palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water produced by the method according to claim 9 further comprising the step of diluting the solution after the suspending agent is hydrated and the antimicrobial agent is sufficiently coated.

12. The palatable antimicrobial drug concentrate, that may be orally administered to an animal in combination with its drinking water produced by the method according to claim 9 wherein the antimicrobial agent has a particle size of 1 μ

to 100μ

.

13. A method of producing a palatable antimicrobial drug concentrate, that may be orally administered, comprising:

preparing a sulfonamide and/or a sulfonamide salt in aqueous solution;

dissolving the sulfonamide and/or a sulfonamide salt in solution;

adding an antimicrobial agent to the solution; and

stirring the solution sufficient enough to suspend the antimicrobial agent.

14. The method according to claim 13 further comprising the step of adding a suspending agent into the solution and stirring the solution until the suspending agent is hydrated and the antimicrobial agent is sufficiently coated.

15. The method according to claim 13 wherein the sulphonamide and/or sulphonamide salt is present in an amount of 2% to 55% and the antimicrobial agent is present in an amount of 0.4% to 18.5%, based on the entire concentrate, and wherein the ratio of the sulphonamide and/or sulfonamide salt to the antimicrobial agent is approximately 10:

1 to 0.1;

1 (w/w).

16. The method according to claim 15 wherein the ratio of the sulphonamide and/or sulfonamide salt to the antimicrobial agent is approximately 3:

1 to 5;

1 (w/w).

17. The method according to claim 14 further comprising the step of adding a sweetener to the solution wherein the sweetener is present in an amount of 0% to 65%, based on the entire weight of the concentrate.

18. The method according to claim 17 further comprising the step of adding a flavoring agent to the solution wherein the flavoring agent is present in an amount of 0% to 10%, based on the entire weight of the concentrate.

19. The method according to claim 18 further comprising the step of adding an antioxidant to the solution wherein the antioxidant is present in an amount of 0% to 5%, based on the entire weight of the concentrate.

20. The method according to claim 19 further comprising the step of adding at least one preservative to the solution wherein at least one preservative is present in an amount of 0% to 1%, based on the entire weight of the concentrate.