.

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

Details for Patent: 8,535,718

« Back to Dashboard

Details for Patent: 8,535,718

Title:Dosage forms of bisphosphonates
Abstract: Provided is an oral dosage form comprising a bisphosphonate selected from the group consisting of a risedronate and salts thereof; an ethylenediaminetetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof; and a delayed release mechanism to deliver the risedronate and the EDTA in the lower gastrointestinal tract, wherein the oral dosage form is administered according to a scheduled dosing interval. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.
Inventor(s): Dansereau; Richard John (Cincinnati, OH), Burgio, Jr.; David Ernest (Liberty Township, OH)
Assignee: Warner Chilcott Company, LLC. (Fajardo, PR)
Filing Date:Jul 09, 2012
Application Number:13/544,377
Claims:1. An oral dosage form comprising: (a) about 150 mg of a bisphosphonate selected from the group consisting of a risedronate and salts thereof; (b) from about 55 mg to about 500 mg of an ethylenediaminetetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof; and (c) a delayed release mechanism to deliver the risedronate and the EDTA in the lower gastrointestinal tract.

2. The oral dosage form of claim 1, wherein the bisphosphonate is risedronate sodium.

3. The oral dosage form of claim 2, wherein the EDTA is disodium EDTA.

4. The oral dosage form of claim 3, wherein the disodium EDTA is from about 75 mg to about 250 mg in the oral dosage form.

5. The oral dosage form of claim 4, wherein the oral dosage form is a tablet.

6. The oral dosage form of claim 5, wherein the delayed release mechanism in an enteric coating.

7. The oral dosage form of claim 6, wherein the enteric coating comprises a methacrylic acid copolymer.

8. The oral dosage form of claim 7, wherein the thickness of the enteric coating is between about 10 microns and about 500 microns.

9. The oral dosage form of claim 8, wherein the methacrylic acid copolymer is poly(methacryclic acid, ethyl acrylate) 1:1.

10. The oral dosage form of claim 7, wherein the weight gain of the enteric coating on the tablet is 5% to 50%.

11. The oral dosage form of claim 10, wherein the methacrylic acid copolymer is poly(methacryclic acid, ethyl acrylate) 1:1.

12. The oral dosage form of claim 7, wherein the enteric coating provides proximal release and delivery in the lower gastrointestinal tract.
« 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