Claims for Patent: 9,579,288

Summary for Patent: 9,579,288

Title:	Tesofensine and beta blocker combination formulations
Abstract:	The present invention relates to a controlled release formulation comprising the active compounds tesofensine and a beta blocker, such as metoprolol or carvedilol, or a pharmaceutically acceptable salt thereof. The invention further relates to use of the controlled release formulation in a method of treatment of diabetes, obesity or an obesity associated disorder.
Inventor(s):	Nielsen; Peter G. (V.ae butted.rlose, DK), Thomsen; Mikael S. (Hvidovre, DK), Hojgaard; Bent (Allerod, DK)
Assignee:	Saniona A/S (Ballerup, DK)
Application Number:	15/058,533
Patent Claims:	1. A pharmaceutical composition comprising a. a first composition in the form of a tablet core comprising an extended release composition of metoprolol or a pharmaceutically acceptable salt thereof, b. a second composition comprising tesofensine or a pharmaceutically acceptable salt thereof, wherein said second composition is a first coating applied to the first composition, and c. a third composition comprising an immediate release composition of metoprolol or a pharmaceutically acceptable salt thereof, wherein the third composition is a second coating applied to the first coating. 2. The pharmaceutical composition of claim 1, wherein the metoprolol pharmaceutical salt is metoprolol succinate or metoprolol tartrate. 3. The pharmaceutical composition of claim 1, wherein the tesofensine or pharmaceutically acceptable salt thereof is tesofensine free base, tesofensine citrate salt, or tesofensine tartrate salt. 4. The pharmaceutical composition of claim 1, wherein the first extended release composition comprises cores comprising metoprolol, the cores being coated with a controlled release layer comprising an admixture of: a. an ethylacrylate/methylmethacrylate copolymer, b. a surfactant, and c. sodium stearyl fumarate, and wherein the controlled release layer has been deposited from a water-containing liquid and the amount of the ethylacrylate/methylmethacrylate copolymer in the film coat is in the range of 80-99.5% (w/w). 5. The pharmaceutical composition of claim 1, wherein the composition is in the form of a pharmaceutical dosage form. 6. The pharmaceutical composition of claim 5, wherein the pharmaceutical dosage form is a tablet. 7. The pharmaceutical composition of claim 1, wherein the first composition comprises 25-200 mg of metoprolol or a pharmaceutically acceptable salt thereof. 8. The pharmaceutical composition of claim 1, wherein the second composition comprises 0.1-1 mg of tesofensine or a pharmaceutically acceptable salt thereof. 9. The pharmaceutical composition of claim 1, wherein the third composition comprises 5-100 mg of metoprolol or a pharmaceutically acceptable salt thereof. 10. The pharmaceutical composition of claim 1, wherein the ratio of extended release metoprolol to immediate release metoprolol is 75-95:25-5. 11. The pharmaceutical composition of claim 1, wherein the first composition comprises 25-200 mg of metoprolol, the third composition comprises 5-50 mg of metoprolol, and the second composition comprises 0.25-0.75 mg of tesofensine.