Patent application EP17168465A (EP), filed 2017-04-27
Publication number: EP3238714A1
Title: EXTENDED RELEASE FORMULATIONS OF FLURBIPROFEN AND TRAMADOL
Abstract: The present invention relates to a pharmaceutical formulation comprising an immediate release phase comprising an effective amount of flurbiprofen and a controlled release phase comprising an effective amount of tramadol and pharmaceutically acceptable excipients.
IPC codes: A61K  31/   135            A I
A61K  31/   192            A I
A61K   9/    20            A I
A61K   9/    24            A I
Claims: number: 1
text: A pharmaceutical formulation comprising an immediate release phase comprising an effective amount of flurbiprofen or a pharmaceutically acceptable salt thereof and a controlled release phase comprising an effective amount of tramadol or a pharmaceutically acceptable salt thereof, and pharmaceutically acceptable excipients.
number: 2
text: The pharmaceutical formulation according to claim 1, wherein the pharmaceutical acceptable salt of tramadol is tramadol HCl.
number: 3
text: The pharmaceutical formulation according to claim 1, flurbiprofen is present in an amount of between 10mg and 300mg, preferably between 10mg and 200mg and more preferably it is in an amount of between 50mg and 200mg.
number: 4
text: The pharmaceutical formulation according to claim 2, tramadol HCl is present in an amount of between 10mg and 400mg, preferably between 20mg and 300mg and more preferably it is in an amount of between 35mg and 150mg.
number: 5
text: The pharmaceutical formulation according to claim 1 or 2, wherein the ratio of flurbiprofen to tramadol HCl is in the range of 0.01 to 30 (w/w), preferably 0.025 to 15 (w/w), more preferably 0.025 to 3 (w/w).
number: 6
text: The pharmaceutical formulation according to claim 1, wherein said pharmaceutical formulation is in the form of tablet, bilayer tablet, trilayer tablet, multilayer tablet, capsule, tablet in tablet, an inlay tablet, injectable preparate, suspension, syrup, sachet, ointment, cream or gel.
number: 7
text: The pharmaceutical formulation according to claim 6, wherein said pharmaceutical composition is in the form of a tablet or a bilayer tablet or a trilayer tablet.
number: 8
text: The pharmaceutical formulation according to claim 1, wherein at least one pharmaceutically acceptable excipient is selected from a group comprising binders, disintegrants, diluents, lubricants and glidants or mixtures thereof.
number: 9
text: The pharmaceutical formulation according to claim 8, wherein binder is polyethylene oxide.
number: 10
text: The pharmaceutical formulation according to claim 9, wherein the amount of polyethylene oxide is between 1.00 - 40.00 %, preferably 5.00 -40.0 % and more preferably it is 5.00-30.00 % by weight of total formulation.
number: 11
text: The pharmaceutical formulation according to claim 7, in the form of a tablet comprising;
number: 12
text: The pharmaceutical formulation according to claim 7, in the form of a bilayer tablet comprising;
Office action: search_report, dated 2017-11-01
Rejection reasons: novelty_epc_54
inventive_step_epc_56
Prior art cited: ref_id: US6339105B1
ref_type: patent
severity: background
ref_id: US2008026054A1
ref_type: patent
severity: background
ref_id: US2008031950A1
ref_type: patent
severity: background
ref_id: [XYI]     - DOROSCHAK ET AL: "Evaluation of the combination of flurbiprofen and tramadol for management of endodontic pain", JOURNAL OF ENDODONTICS, LIPPINCOTT WILLIAMS & WILKINS, PHILADELPHIA, PA, US, vol. 25, no. 10, 1 October 1999 (1999-10-01), pages 660 - 663, XP022195675, ISSN: 0099-2399, DOI: 10.1016/S0099-2399(99)80350-1
ref_type: npl
severity: background
ref_id: US2008026054
ref_type: patent
severity: novelty_destroying
ref_id: US2008031950
ref_type: patent
severity: novelty_destroying
ref_id: - DOROSCHAK ET AL, "Evaluation of the combination of flurbiprofen and tramadol for management of endodontic pain", JOURNAL OF ENDODONTICS, LIPPINCOTT WILLIAMS & WILKINS, PHILADELPHIA, PA, US, (19991001), vol. 25, no. 10, doi:10.1016/S0099-2399(99)80350-1, ISSN 0099-2399, pages 660 - 663, XP022195675 [X] 1,3,6,8 * page  660, column  l * * figure - * [Y] 2,3,5 [I] 4
ref_type: npl
severity: novelty_destroying
Final disposition: pending (2017-11-01)