You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for Patent: 6,746,692


✉ Email this page to a colleague

« Back to Dashboard


Title: Modified release pharmaceutical formulation comprising amoxycillin
Abstract:Bacterial infections may be treated using a high dosage regimen of amoxycillin and potassium clavulanate. Preferably, the dosage is provided by a bilayer tablet.
Inventor(s): Conley; Creighton P. (Bristol, TN), Roush; John A. (Kingsport, TN), Storm; Kevin H. (Bristol, TN)
Assignee: Beecham Pharmaceuticals (Pte) Limited (Jurong, SG)
Filing Date:Apr 04, 2002
Application Number:10/115,700
Claims:1. A modified release pharmaceutical composition comprising compacted granules of a pharmaceutically acceptable soluble salt of amoxycillin and at least one pharmaceutically acceptable organic acid which are admixed, as solids, in intimate contact at a ratio from about 20:1 to 1:2 (of the pharmaceutically acceptable soluble salt of amoxycillin to the at least one pharmaceutically acceptable organic acid), and a pharmaceutically acceptable diluent or compression aid.

2. A modified release composition according to claim 1 in the form of a tablet.

3. A modified release composition according to claim 1 wherein the pharmaceutically acceptable soluble salt of amoxycillin is comprises crystallized sodium amoxycillin.

4. A composition according to claim 1 wherein the pharmaceutically acceptable soluble salt of amoxycillin is sodium amoxycillin.

5. A composition according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from pharmaceutically acceptable monocarboxylic and polycarboxylic acids having from 2 to 25 carbon atoms, pharmaceutically acceptable monocyclic aryl and polycyclic aryl acids, and pharmaceutically acceptable monohydrogen and dihydrogen metal salts of any of the foregoing multi-valent acids.

6. A composition according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from pharmaceutically acceptable monocarboxylic and polycarboxylic acids having from 2 to 10 carbon atoms and an acidic salt of any of the foregoing.

7. A composition according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from C.sub.(2-10) alkyl- and C.sub.(2-10) alkenyl-carboxylic acids having one, two, or three carboxylic acid groups, and optionally at least one hydroxy substituent, and optionally at least one --CO group in the carbon chain and an acidic salt of any of the foregoing.

8. A composition according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, sorbic acid, tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt of any of the foregoing.

9. A composition according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is citric acid.

10. A composition according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is citric acid anhydrous.

11. A composition according to claim 1 wherein the amount of the pharmaceutically acceptable soluble salt of amoxycillin is about 438 mg +/-5%.

12. A composition according to claim 1 wherein the granules further comprise at least one release retarding excipient which is selected from pH sensitive polymers, release-retarding polymers which exhibit swelling characteristics when in an aqueous environment, polymeric materials which exhibit gelling characteristics when in an aqueous environment, and polymeric materials which exhibit both swelling and gelling characteristics when in an aqueous environment.

13. A composition according to claim 12 wherein the at least one release retarding excipient is selected from methylcellulose, carboxymethylcelluloses, low-molecular weight hydroxypropylmethylcellulose, low-molecular weight polyvinylalcohol, polyoxyethyleneglycol, and noncross-linked polyvinylpyrrolidone.

14. A composition according to claim 12 wherein the at least one release retarding polymer is selected from medium-viscosity hydroxypropylmethylcellulose, and medium viscosity polyvinylalcohol.

15. A composition according to claim 12 wherein the at least one release retarding excipient is xanthan gum.

16. A composition according to claim 15 wherein the xanthan gum is present in an amount from about 0.5% to about 8% by weight.

17. A composition according to claim 15 wherein the xanthan gum is present in an amount from about 1% to about 5% by weight.

18. A composition according to claim 15 wherein the xanthan gum is pharmaceutical grade xanthan gum, 200 mesh.

19. A composition according to claim 1 wherein the diluent is lactose.

20. A composition according to claim 1 wherein the compression aid is microcrystalline cellulose.

21. A composition according to claim 1 wherein the pharmaceutically acceptable soluble salt of amoxycillin and the at least one pharmaceutically acceptable organic acid are admixed in intimate contact such that upon exposure to an aqueous environment they interact such that the rate of release of amoxycillin from the solid form of the second release phase is reduced when compared to the rate of release of amoxycillin from an immediate release formulation.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.