Details for Patent: 8,580,954

Title:	Formulations of low dose diclofenac and beta-cyclodextrin
Abstract:	The present invention is directed to a pharmaceutical composition containing a unit dose of a diclofenac compound effective to induce analgesia; and a beta-cyclodextrin compound; wherein the dose of the diclofenac compound is less than 10 mg. The present invention is also directed to methods of treating a subject in need of analgesia with the pharmaceutical compositions of the invention.
Inventor(s):	Wright; Curtis (Rockport, MA), Carr; Daniel B. (Chestnut Hill, MA), Mermelstein; Fred H. (Newton, MA)
Assignee:	Hospira, Inc. (Lake Forest, IL)
Filing Date:	Mar 22, 2007
Application Number:	11/689,931
Claims:	1. A method for treating a mammal in need of analgesia, comprising administering a pharmaceutical composition comprising: (a) a unit dose of diclofenac sodium effective to induce analgesia; and (b) a beta-cyclodextrin compound; (c) a stabilizer; wherein the unit dose of the diclofenac sodium is between about 3.75 mg to about 9.4 mg; and wherein the pharmaceutical composition is formulated for parenteral administration. 2. A method for treating a mammal in need of analgesia, comprising administering a pharmaceutical composition comprising: (a) a unit dose of diclofenac sodium effective to induce analgesia; (b) a beta-cyclodextrin compound; and (c) a stabilizer; wherein the unit dose of the diclofenac sodium is less than about 5 mg; and wherein the pharmaceutical composition is administered parenterally, wherein parenteral administration refers to intravenous administration or intramuscular administration. 3. A method for treating a mammal in need of analgesia, comprising administering a pharmaceutical composition to the mammal in need thereof, wherein the pharmaceutical composition comprises: (a) a unit dose of diclofenac sodium effective to induce analgesia; and (b) a beta-cyclodextrin compound; (c) a stabilizer; wherein the unit dose of the diclofenac sodium is less than 10 mg; and wherein the pharmaceutical composition is administered intravenously. 4. A method for treating a mammal in need of analgesia, comprising administering a pharmaceutical composition to the mammal in need thereof, wherein the pharmaceutical composition comprises: (a) a unit dose of diclofenac sodium effective to induce analgesia; and (b) a beta-cyclodextrin compound; (c) a stabilizer; wherein the dose of the diclofenac sodium is less than 5 mg (+/-20%); and wherein the pharmaceutical composition is administered intravenously.