Patent application EP17171787A (EP), filed 2017-05-18
Publication number: EP3246020A1
Title: NEW ORAL PHARMACEUTICAL FORMULATIONS OF DABIGATRAN
Abstract: The present invention relates to new oral pharmaceutical formulations comprising dabigatran etexilate free base and cyclodextrin with least one pharmaceutically acceptable excipient.
IPC codes: A61K  31/  4439            A I
A61K   9/    20            A I
A61K   9/    48            A I
Claims: number: 1
text: Pharmaceutical formulations comprising dabigatran etexilate free base and cyclodextrin.
number: 2
text: The pharmaceutical formulations according to claim 1, wherein the amount of dabigatran etexilate free base is between 5.0 to 85.0 % by weight of total formulation.
number: 3
text: The pharmaceutical formulations according to claim 1, wherein the amount of cyclodextrin is between 1.0 to 50.0% by weight of total formulation.
number: 4
text: The pharmaceutical formulations according to claim 1, further comprising at least one disintegrant.
number: 5
text: The pharmaceutical formulations according to claim 4, wherein the disintegrants are selected from the group comprising sodium starch glycolate, cross-linked polyvinil pyrrolidone, magnesium aluminium silica, sodium dodecyl sulphate, sodium carboxymethyl cellulose, carboxymethyl calcium, low substituted hydroxypropyl methyl cellulose, poloxamer or mixtures thereof.
number: 6
text: The pharmaceutical formulations according to claim 5, wherein the disintegrants are preferably sodium starch glycolate or cross-linked polyvinil pyrrolidone or mixtures thereof.
number: 7
text: The pharmaceutical formulations according to claim 6, wherein the total amount of disintegrants is between 0.5 - 30% by weight of the total formulation.
number: 8
text: The pharmaceutical formulations according to claim 1 or 4, further comprising at least one pharmaceutically acceptable excipient other than disintegrant which is selected from the group comprising fillers, binders, lubricants, glidants, acids, melting components, plasticizers or mixtures thereof.
number: 9
text: The pharmaceutical formulations according to any preceding claims, comprising
number: 10
text: The pharmaceutical formulations according to any preceding claims, comprising
number: 11
text: The pharmaceutical formulations according to any preceding claims, comprising
number: 12
text: The pharmaceutical formulations according to any preceding claims, comprising
number: 13
text: The pharmaceutical formulations according to any preceding claims, comprising
number: 14
text: The pharmaceutical formulations according to claims 9 to 13, wherein said pharmaceutical formulations are in the formof tablets, coated or uncoated tablets, capsules, multilayer tablets, buccal tablets, sublingual tablets, tablet in tablets, in-lay tablets, effervescent tablets, immediate release tablets, modified release tablets, orally disintegrating tablet, film-coated tablets, enteric coated tablets, pills, hard or soft gelatin capsules, powders, mini tablets, pellets, coated bead systems, granules, dragees, sachets, films, orally administrable films or solids.
number: 15
text: The pharmaceutical formulations according to claim 14, wherein said pharmaceutical formulations are in the form of tablet or capsule.
Office action: search_report, dated 2017-11-22
Rejection reasons: novelty_epc_54
inventive_step_epc_56
Prior art cited: ref_id: WO9837075A1
ref_type: patent
severity: background
ref_id: EP1870100A1
ref_type: patent
severity: background
ref_id: WO2012077136A2
ref_type: patent
severity: background
ref_id: EP1877395A2
ref_type: patent
severity: background
ref_id: WO2017013106A1
ref_type: patent
severity: background
ref_id: US2013190358A1
ref_type: patent
severity: background
ref_id: EP2722033A1
ref_type: patent
severity: background
ref_id: EP2722034A1
ref_type: patent
severity: background
ref_id: - DAVIS M E ET AL: "Cyclodextrin-based pharmaceutics: past, present and future", NATURE REVIEWS. DRUG DISCOVERY, NATURE PUBLISHING GROUP, GB, vol. 3, no. 12, 1 December 2004 (2004-12-01), pages 1023 - 1035, XP002613123, ISSN: 1474-1776, DOI: 10.1038/NRD1576
ref_type: npl
severity: background
ref_id: US2013190358
ref_type: patent
severity: novelty_destroying
ref_id: EP2722033
ref_type: patent
severity: obviousness
ref_id: EP2722034
ref_type: patent
severity: obviousness
ref_id: - DAVIS M E ET AL, "Cyclodextrin-based pharmaceutics: past, present and future", NATURE REVIEWS. DRUG DISCOVERY, NATURE PUBLISHING GROUP, GB, (20041201), vol. 3, no. 12, doi:10.1038/NRD1576, ISSN 1474-1776, pages 1023 - 1035, XP002613123 [A] 1-15 * the whole document *
ref_type: npl
severity: background
Final disposition: pending (2017-11-22)