.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 7,919,116

« Back to Dashboard

Claims for Patent: 7,919,116

Title:Controlled release metformin formulations
Abstract: Sustained release pharmaceutical formulations comprising an antihyperglycemic drug or a pharmaceutically acceptable salt thereof are disclosed. The formulations provide therapeutic plasma levels of the antihyperglycemic drug to a human patient over a 24 hour period after administration.
Inventor(s): Chen; Chih-Ming (Taipei, TW), Cheng; Xiu Xiu (Weston, FL), Jan; Steve (Coral Springs, FL), Chou; Joseph (Manassas, VA)
Assignee: Andrx Labs, LLC (Davie, FL)
Application Number:11/713,143
Patent Claims: 1. A method of treating a human diabetic patient with an oral solid sustained release tablet of metformin hydrochloride, comprising: administering the sustained release tablet to the human diabetic patient once a day under fed conditions, wherein the sustained release tablet comprises (i) metformin hydrochloride and (ii) a sustained release material, wherein the tablet does not employ an expanding polymer, the sustained release tablet provides therapeutic plasma levels of said metformin to the human patient over a 12 to 24 hour period after administration; and the sustained release tablet exhibits the following in vitro dissolution profile when tested in a USP Type 2 apparatus at 75 rpms in 900 ml of a pH 7.5 phosphate buffer and 37.degree. C.: 0-25% of the metformin is released after 2 hours; 10-45% of the metformin is released after 4 hours; 30-90% of the metformin is released after 8 hours; not less than 50% of the metformin is released after 12 hours; not less than 60% of the metformin is released after 16 hours and not less than 70% of the metformin is released after 20 hours.

2. The method as defined in claim 1 wherein the tablet exhibits the following in vitro dissolution profile when tested in a USP Type 2 apparatus at 75 rpms in 900 ml of a pH 7.5 phosphate buffer and 37.degree. C.: 0-15% of the metformin is released after 2 hours; 20-40% of the metformin is released after 4 hours; 45-90% of the metformin is released after 8 hours; not less than 60% of the metformin is released after 12 hours; not less than 70% of the metformin is released after 16 hours and not less than 80% of the metformin is released after 20 hours.

3. The method of claim 1 wherein the tablet is administered with or after a meal.

4. The method of claim 1 wherein the tablet is administered with or after evening meal.

5. The method of claim 1 wherein the tablet is an osmotic tablet with a homogeneous osmotic core.
« Back to Dashboard

For more information try a trial or see the database preview and plans and 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 verifification 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.

`abc