IP Library Granted Patent US 8,425,936
Granted Patent B2
US 8,425,936 · App. 10/894,787 · Granted Apr 23, 2013

Antibiotic product, use and formulation thereof

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Quick Facts
Patent No.
US 8,425,936
App. No.
10/894,787
Granted
Apr 23, 2013
Kind
B2
Abstract

An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the C max for the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more sustained release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a C max at different times.

Claims (22)

1. A once-a-day antibiotic product comprising: first, second, and third antibiotic dosage forms, each of said antibiotic dosage forms comprising at least one antibiotic and a pharmaceutically acceptable carrier, said first antibiotic dosage form being an immediate release dosage form, said second and third antibiotic dosage forms being sustained release dosage forms, wherein the antibiotic released from the first dosage form reaches a Cmax within from about 0.5 hours to about 2 hours after administration of the product, wherein said second dosage form initiates release of antibiotic at about the same time as said first dosage form initiates release of antibiotic, and wherein said third dosage form initiates release of antibiotic after said second dosage form initiates release of antibiotic, and Cmax of the total antibiotic released from said antibiotic product is achieved in less than about 12 hours from administration and said once-a-day antibiotic product contains the total dosage of the at least one antibiotic for a twenty-four hour period, wherein the product is an oral dosage form, wherein the antibiotic released from the second dosage form reaches a Cmax after Cmax is reached for the antibiotic released from the first dosage form, and wherein the first dosage form contains about 20-70% of the total dosage of antibiotic, the second dosage form contains about 10-70% of the total dosage of antibiotic, and the third dosage form contains about 10-70% of the total dosage of antibiotic.

2. The product of claim 1 , wherein the Cmax for the product is reached no earlier than four hours after administration.

3. The product of claim 1 , wherein the antibiotic released from the third dosage form reaches a Cmax after Cmax is reached for the antibiotic released from the second dosage form.

4. The product of claim 1 . wherein the first dosage form contains about 25-66% of the total dosage of antibiotic, the second dosage form contains about 15-60% of the total dosage of antibiotic, and the third dosage form contains about 15-60% of the total dosage of antibiotic.

5. The product of claim 1 further comprising a fourth antibiotic dosage form, said fourth antibiotic dosage form being either a sustained or a delayed release dosage form and comprising at least one antibiotic and a pharmaceutically acceptable carrier and wherein said at least one antibiotic released from said fourth antibiotic dosage form reaches a Cmax after Cmax is achieved for antibiotic released from each of said first, second, and third dosage forms.

6. A process for treating a bacterial infection in a host comprising:

administering to a host the antibiotic product of claim 1 , once-a-day.

7. A process for treating a bacterial infection in a host comprising:

administering to a host the antibiotic product of claim 2 , once-a-day,

8. A process for treating a bacterial infection in a host comprising:

administering to a host the antibiotic product of claim 3 , once-a-day.

9. A process for treating a bacterial infection in a host comprising:

administering to a host the antibiotic product of claim 4 , once-a-day.

10. A process for treating a bacterial infection in a host comprising:

administering to a host the antibiotic product of claim 5 , once-a-day.

11. The product of claim 1 , wherein said at least one antibiotic is amoxicillin.

12. A process for treating a bacterial infection in a host comprising administering to a host the antibiotic product of claim 11 , once-a-clay.

13. The product of claim 5 , wherein the Cmax for the product is reached no earlier than four hours after administration.

14. The product of claim 5 , wherein the antibiotic released from the second dosage form reaches a Cmax in no more than about 4 hours after administration of the product.

15. The product of claim 12 , wherein the antibiotic released from the third dosage form reaches a Cmax after Cmax is reached for the antibiotic released from the second dosage form.

16. The product of claim 1 , wherein said at least one antibiotic is cephalexin.

17. A process for treating a bacterial infection in a host comprising: administering to a host the antibiotic product of claim 16 , once-a-day.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 3, 2011
From: VICTORY PHARMA, INC.
To: SHIONOGI INC.
Reel/Frame 027004/0189 →
SECURITY AGREEMENT Recorded Jul 29, 2011
From: BANK OF AMERICA, N.A.
To: VICTORY PHARMA, INC.
Reel/Frame 026676/0070 →
SECURITY INTEREST Recorded Oct 8, 2010
From: VICTORY PHARMA, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 025114/0848 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 9, 2010
From: MIDDLEBROOK PHARMACEUTICALS, INC.
To: VICTORY PHARMA, INC.
Reel/Frame 024964/0036 →
CHANGE OF NAME Recorded Nov 9, 2007
From: ADVANCIS PHARMACEUTICAL CORPORATION
To: MIDDLEBROOK PHARMACEUTICALS, INC.
Reel/Frame 020089/0910 →