.

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: 8,426,472

« Back to Dashboard

Details for Patent: 8,426,472

Title:Method and composition for administering an NMDA receptor antagonist to a subject
Abstract: The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (San Francisco, CA)
Assignee: Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Filing Date:Oct 28, 2011
Application Number:13/284,630
Claims:1. A method of administering memantine to a human subject in need thereof, comprising: orally administering to the subject once per day over multiple days a sustained release oral dosage form comprising memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or the salt thereof; wherein a daily dose of 12.5 to 40 mg of memantine or pharmaceutically acceptable salt thereof is administered from the initiation of therapy without prior dose escalation of memantine; wherein such administration results in the subject achieving a therapeutically effective steady state memantine plasma concentration within 20 days after initiation of therapy with said dosage form; and wherein the subject has a condition selected from the group consisting of Alzheimer's disease, dementia, Parkinson's disease and neuropathic pain.

2. The method of claim 1, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) in a defined time period of 0 to 6 hours after administration as measured in a single dose human PK study, that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine in said defined time period.

3. The method of claim 1, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, wherein the dC/dT is measured in a single dose human PK study between the time period of 0 to Tmax of the immediate release form of memantine.

4. The method of claim 1, wherein the dosage form has a memantine in vitro dissolution profile ranging between 0.1-20% in one hour, 5-30% in two hours, 40-80% in six hours, and 50 to 90% in 10 hours, wherein the dissolution profile is determined using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5.degree. C., in 500 ml water.

5. The method of claim 1, wherein said subject has not been administered memantine or a pharmaceutically acceptable salt thereof within one week prior to the initiation of therapy with said sustained release oral dosage form.

6. A method of administering memantine to a human subject in need thereof, comprising: orally administering to the subject once per day over multiple days a sustained release oral dosage form comprising memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or the salt thereof; wherein 12.5 to 40 mg of memantine or pharmaceutically acceptable salt thereof is administered daily from the initiation of therapy without prior dose escalation of memantine; wherein daily administration of 12.5 to 40 mg of memantine or pharmaceutically acceptable salt thereof results in the subject achieving a therapeutically effective steady state memantine plasma concentration within 20 days after initiation of therapy with said dosage form; and wherein the subject has a condition selected from the group consisting of Alzheimer's disease, dementia, Parkinson's disease and neuropathic pain.

7. The method of claim 6, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) in a defined time period of 0 to 6 hours after administration as measured in a single dose human PK study, that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine in said defined time period.

8. The method of claim 6, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, wherein the dC/dT is measured in a single dose human PK study between the time period of 0 to Tmax of the immediate release form of memantine.

9. The method of claim 6, wherein the dosage form has a memantine in vitro dissolution profile ranging between 0.1-20% in one hour, 5-30% in two hours, 40-80% in six hours, and 50 to 90% in 10 hours, wherein the dissolution profile is determined using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5.degree. C., in 500 ml water.

10. The method of claim 6, wherein said subject has not been administered memantine or a pharmaceutically acceptable salt thereof within one week prior to the initiation of therapy with said sustained release oral dosage form.
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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