Synergistic admixtures of Gabapentin and Ketoprofen, pharmaceutical compositions and their medical use
The present invention relates to a synergistic admixture of Gabapentin and Ketoprofen, preferably Ketoprofen Lysine, to a pharmaceutical composition comprising said admixtures and to the use of said admixtures or pharmaceutical compositions in the treatment of acute or chronic pain, in particular in the treatment of neuropathic or inflammatory pain.
1 . A pharmaceutical composition comprising an admixture of synergistically effective molar ratios of Gabapentin and Ketoprofen, wherein the Ketoprofen is Ketoprofen Lysine co-crystal Form I characterized by an X-ray diffraction pattern with characteristic peaks at 16.3, 17.5, 17.6, 17.7, 19.6, and 19.7° 2theta ±0.20 degrees, and at least one pharmaceutically acceptable excipient, wherein the composition is an oral solid or liquid composition.
2 . The admixture of claim 1 , wherein the molar ratio of the components is comprised between 100:1 and 1:100.
3 . The admixture of claim 2 , wherein the molar ratio of the components is comprised between 50.1 and 1:50.
4 . The admixture of claim 1 , wherein the molar ratio of the components is comprised between 20:1 and 1:20.
5 . The admixture of claim 4 , wherein the molar ratio of the components is comprised between 10:1 and 1:10.
6 . The admixture of claim 5 , wherein the molar ratio of the components is comprised between 5:1 and 1:5.
7 . The admixture of claim 6 , wherein the molar ratio of the components is comprised between 2:1 and 1:2.
8 . The admixture of claim 1 , wherein the Ketoprofen is (S)-Ketoprofen.
9 . The admixture of claim 1 , wherein the Lysine is (S)-Lysine.
10 . A method for the prevention, reduction or treatment of pain and/or inflammation in a subject in need thereof, comprising oral administration of the composition according to claim 1 .
11 . The method according to claim 10 , wherein the pain is acute or chronic pain.
12 . The method according to claim 10 , wherein said pain is selected from headache, toothache, menstrual pain, muscle pain, neuropathic pain, pain associated to neuroinflammation, diabetic neuropathy, cancer pain, osteoarthritis, low back pain, sciatalgia, fibromyalgia, trigeminal neuralgia; post-surgical and post-operative pain, post herpetic neuralgia, rheumatoid arthritis, ankylosing spondylitis, frozen shoulder, phantom limb pain or HIV pain.
13 . The pharmaceutical composition of claim 1 , which contains 0.5-60% by weight of said admixture and 40-99.5% by weight of one or more pharmaceutically acceptable excipients.
14 . A pharmaceutical composition comprising an admixture of Gabapentin and Ketoprofen, wherein the Ketoprofen is Ketoprofen Lysine co-crystal Form I characterized by an X-ray diffraction pattern with characteristic peaks at 16.3, 17.5, 17.6, 17.7, 19.6, and 19.7° 2theta ±0.20 degrees, and wherein the molar ratio of the Gabapentin and the Ketoprofen is 1:1, and at least one pharmaceutically acceptable excipient, wherein the composition is an oral solid or liquid composition.