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Details for Patent: 8,889,187

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Details for Patent: 8,889,187

Title:Once a day amoxicillin product comprising immediate and delayed release dosage forms
Abstract: An antibiotic product is comprised of at least two dosages forms, each of which has a different release profile, with the C.sub.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 one or more delayed release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a C.sub.max at different times.
Inventor(s): Rudnic; Edward M (N. Potomac, MD), Isbister; James D (Potomac, MD), Treacy, Jr.; Donald J (Annapolis, MD), Wassink; Sandra E (Frederick, MD)
Assignee: Shionogi Inc. (Florham Park, NJ)
Filing Date:Oct 14, 2011
Application Number:13/273,966
Claims:1. A once-a-day amoxicillin product comprising at least two dosage forms, wherein the at least two dosage forms consist of a first amoxicillin dosage form and a second amoxicillin dosage form, wherein each of the first and second amoxicillin dosage forms comprises a pellet or a particle comprising a pharmaceutically active ingredient and a pharmaceutically acceptable carrier, the pharmaceutically active ingredient consisting of amoxicillin, wherein the first amoxicillin dosage form is an immediate release dosage form, the second dosage form is a delayed release dosage form, wherein the pellet or the particle of the second dosage form is coated with a non-pH sensitive delayed release component or an enteric release component, and wherein each of the first and second amoxicillin dosage farms initiates release of amoxicillin at different times and Cmax of the total amoxicillin released from the amoxicillin product is achieved in less than about 12 hours from administration, the once-a-day amoxicillin product contains the total dosage of amoxicillin for a twenty-four hour period.

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 amoxicillin released from the first dosage form reaches a Cmax within from about 0.5 hours to about hours after administration of the product.

4. The product of claim 1, wherein the amoxicillin released from the second dosage form reaches a Cmax in no more than about 4 hours after administration of the product.

5. The product of claim 1, wherein the product is an oral dosage form.

6. The product of claim 1, wherein the pellet or the particle is formed into a unitary pharmaceutical product.

7. A process for treating a bacterial infection in a host comprising: administering to a host the amoxicillin product of claim 1 once-a-day.

8. A once-a-day amoxicillin product comprising at least two dosage forms, wherein the at least two dosage forms consist of a first amoxicillin dosage form and a second amoxicillin dosage form, wherein each of the first and second amoxicillin dosage forms comprises a pellet or a granule comprising a pharmaceutically active ingredient and a pharmaceutically acceptable carrier, the pharmaceutically active ingredient consisting of amoxicillin, wherein the first amoxicillin dosage form is an immediate release dosage form, the second dosage form is a delayed release dosage form, wherein the pellet or the granule of the second dosage form is coated with a non-pH sensitive delayed release component or an enteric release component, and wherein each of the first and second amoxicillin dosage forms initiates release of amoxicillin at different times and C.sub.max of the total amoxicillin released from the amoxicillin product is achieved in less than about 12 hours from administration, the once-a-day amoxicillin product contains the total dosage of amoxicillin for a twenty-four hour period.

9. The product of claim 8, wherein the C.sub.max for the product is reached no earlier than four hours after administration.

10. The product of claim 8, wherein the amoxicillin released from the first dosage form reaches a C.sub.max within from about 0.5 hours to about 2 hours after administration of the product.

11. The product of claim 8, wherein the amoxicillin released from the second dosage form reaches a C.sub.max in no more than about 4 hours after administration of the product.

12. The product of claim 8, wherein the product is an oral dosage form.

13. The product of claim 8, wherein the pellet or the granule is formed into a unitary pharmaceutical product.
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