Formulations of low dose diclofenac and beta-cyclodextrin
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.
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.