Pharmaceutical formulation for reducing pain
The present invention is directed to a method of producing analgesia in a mammalian subject. The method includes administering to the subject an omega conopeptide, preferably ziconotide, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil, or its pharmaceutically acceptable salts thereof, wherein the ω-conopeptide retains its potency and is physically and chemically compatible with the analgesic compound. A preferred route of administration is intrathecal administration, particularly continuous intrathecal infusion. The present invention is also directed to a pharmaceutical formulation comprising an omega conopeptide, preferably ziconotide, an antioxidant, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil.
1. A pharmaceutical formulation comprising an ω-conopeptide, an antioxidant, and bupivacaine or the pharmaceutically acceptable salts thereof, wherein the pharmaceutical formulation is prepared by mixing 100 μg/mL of the ω-conopeptide with 7.5 mg/mL of bupivacaine in a volume ratio between 1:8 and 8:1.
2. The pharmaceutical formulation according to claim 1 , wherein the ω-conopeptide retains its potency and is physically and chemically compatible with the bupivacaine in the formulation.
3. The pharmaceutical formulation according to claim 1 , wherein said ω-conopeptide is ziconotide.
4. The pharmaceutical formulation according to claim 1 , wherein said antioxidant is methionine.
5. The pharmaceutical formulation according to claim 1 , which has pH between 4 to 4.5.
6. The pharmaceutical formulation according to claim 1 , wherein said ω-conopeptide retains at least 80% activity at 37° C. for at least 7 days.
7. A method for reducing pain in a human patient, comprising:
administering to a human patient in need thereof the pharmaceutical formulation according to claim 1 .