# US 2013/0156854 A1 · Controlled Release Pharmaceutical Compositions of Milnacipran > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0156854 A1 - Document ID: US20130156854A1 - Status: Published application - Kind: A1 - Application number: 13/819,415 - Filed: 2011-08-26 - Published: 2013-06-20 - Earliest claimed: 2010-08-30 - Assignees: Lupin Limited - Inventors: Shirishkumar Kulkarni; Rajesh Kulkarni; Pandharinath Jadhav; Ashish Tiwari - Web page: https://patentgrep.com/patent/US20130156854A1 ## CPC - A61K 31/164: of a carboxylic acid with an aminoalcohol, e.g. ceramides - A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - A61K 9/2095: {Tabletting processes} - A61K 9/2886: {having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer (of the type active core-drug layer-inactive layer A61K9/209)} - A61K 9/2893: {Tablet coating processes (mechanical aspects A61J3/06)} - A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide - A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin - A61K 31/439: the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46) - A61K 45/00: Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00 - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 25/04: Centrally acting analgesics, e.g. opioids - A61P 25/24: Antidepressants - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract A controlled release pharmaceutical compositions comprising Milnacipran or pharmaceutically acceptable salts there—of is provided. The pharmaceutical composition comprises an immediate release core comprising Milnacipran or pharmaceutically acceptable salts thereof, pharmaceutically acceptable excipients and a coating on the immediate release core comprising rate controlling agents. ## Claims ### Claim 1 A controlled release pharmaceutical composition comprising an immediate release core comprising Milnacipran or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient and a coating on the immediate release core comprising a rate controlling agent. ### Claim 2 (depends on 1) The controlled release pharmaceutical composition of claim 1, further comprises an antiemetic drug. ### Claim 3 (depends on 2) The controlled release pharmaceutical composition of claim 2, wherein the antiemetic drug is selected from Dolasetron, Granisetron, Ondansetron, Tropisetron and Palonosetron. ### Claim 4 (depends on 1) The controlled release pharmaceutical composition of claim 1, wherein the rate controlling agent is water insoluble but semi permeable or permeable to physiological fluids. ### Claim 5 (depends on 4) The controlled release pharmaceutical composition of claim 4, wherein the rate controlling agent is selected from hydroxypropyl methyl cellulose acetate succinate, hydroxy propyl methylcellulose phthalate, methylcellulose, ethylcellulose, cellulose acetate, cellulose acetate phthalate, cellulose acetate trimellitate, carboxymethylcellulose sodium; acrylic acid polymers and copolymers, preferably formed from acrylic acid, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate and/or ethyl methacrylate, and other methacrylic resins; vinyl polymers and copolymers such as polyvinyl pyrrolidone, vinyl acetate, vinylacetate phthalate, vinyl acetate crotonic acid copolymer, ethylene-vinyl acetate copolymer; enzymatically degradable polymers such as azo polymers, pectin, chitosan, amylase, guar gum, zein, shellac or a combination thereof. ### Claim 6 (depends on 1) The controlled release pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable excipient is selected from diluent, a binder, a lubricant, or a glidant. ### Claim 7 The controlled release pharmaceutical composition of Milnacipran or a pharmaceutically acceptable salt thereof wherein the composition releases at least 90% of Milnacipran between 8 to 20 hours, when dissolution is carried out in 900 ml of 0.1 N HCl, USP apparatus Type I (Basket) at 100 RPM. ### Claim 8 (depends on 7) The controlled release pharmaceutical composition of claim 7, wherein the pharmaceutical composition releases at least 90% of Milnacipran in 12 hours. ### Claim 9 A controlled release pharmaceutical composition of Milnacipran or a pharmaceutically acceptable salt thereof, wherein the composition exhibits a mean Cmax in the range of about 50 ng/ml to about 500 ng/ml under fed condition. ### Claim 10 (canceled) ### Claim 11 (depends on 1) The controlled release pharmaceutical composition of claim 1, in which the Milnacipran or pharmaceutically acceptable salt thereof is Milnacipran HCl. ### Claim 12 (depends on 2) The controlled release pharmaceutical composition of claim 2, wherein the antiemetic drug is coated onto the coating comprising the rate controlling agent.