Patent application EP16160794A (EP), filed 2016-03-17
Publication number: EP3219309A1
Title: FIXED DOSED PHARMACEUTICAL COMPOSITION COMPRISING AMLODIPINE, CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE FOR THE TREATMENT OF HYPERTENSION
Abstract: The present invention relates to fixed dose pharmaceutical compositions comprising the active substances Candesartan cilexetil, Amlodipine and Hydrochlorothiazide for the treatment of hypertension.
IPC codes: A61K  31/  4184            A I
A61K  31/  4422            A I
A61K  31/   549            A I
A61K   9/    20            A I
Claims: number: 1
text: A fixed dose pharmaceutical composition comprising the active substances Candesartan cilexetil, Amlodipine and Hydrochlorothiazide for the treatment of hypertension.
number: 2
text: A fixed dose pharmaceutical composition according to claim 1 in the form of a tablet, comprising
number: 3
text: A fixed dose pharmaceutical composition according to claim 2, wherein
number: 4
text: A fixed dose pharmaceutical composition according any of the preceding claims, comprising one or more disintegrants being selected from carboxymethyl cellulose (carmellose), sodium starch glycolate, polyvinylpyrrolidone, crospovidone and croscarmellose, preferably carmellose calcium.
number: 5
text: A fixed dose pharmaceutical composition according to any of the preceding claims, comprising one or more binders being selected from hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), dihydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose, ethyl cellulose, sodium carboxymethyl cellulose, polyethylene glycol, maltodextrin, pregelatinized starch, polymethacrylates, sodium alginate, polyvinylpyrrolidone (povidone) and vinylpyrrolidone/vinylacetate copolymer (copovidone) and mixtures thereof, preferably hydroxypropyl cellulose (HPC).
number: 6
text: A fixed dose pharmaceutical composition according any of the preceding claims, comprising one or more fillers being selected from lactose, starch, microcrystalline cellulose (MCC), sucrose, mannitol, dicalcium phosphate, calcium carbonate, magnesium carbonate, low substituted hydroxypropyl cellulose (L-HPC), powder cellulose, calcium silicate, calcium phosphate, sorbitol, dextrin, kaolin, magnesium oxide, calcium sulfate, xylitol, isomalt, glucose, fructose, maltose and mixtures thereof, preferably being selected from lactose monohydrate, maize starch, microcrystalline cellulose (MCC) and mixtures thereof.
number: 7
text: A fixed dose pharmaceutical composition according any of the preceding claims, comprising one or more lubricants being selected from magnesium stearate, calcium stearate, sodium stearate, stearic acid, sodium glyceryl behenate, hexanedioic acid, hydrogenated vegetable oil sodium, stearyl fumarate, glycerin fumarate and mixtures thereof, preferably magnesium stearate.
number: 8
text: A fixed dose pharmaceutical composition according to any of claims 3 to 7, wherein
number: 9
text: A fixed dose pharmaceutical composition according to any of claims 3 to 8, wherein
number: 10
text: A fixed dose pharmaceutical composition according to any one of the preceding claims, comprising polyethylene glycol (PEG) in a ratio of from 1.0:6.0 to 1.0:8.0 by weight relative to Candesartan cilexetil.
number: 11
text: A fixed dose pharmaceutical composition according to any one of the preceding claims, wherein the D<90> -value of the particle size distribution of Candesartan cilexetil ranges from 1.0 µm to 10.0 µm, preferably from of 4.0 µm to 8.0 µm.
number: 12
text: A fixed dose pharmaceutical composition according to any one of the preceding claims, comprising
number: 13
text: A set of fixed dose pharmaceutical compositions according to claim 12, comprising 5 mg/16 mg/12.5 mg, 10 mg/16 mg/12.5 mg, 5 mg/32 mg/25 mg and 10 mg/32 mg/25 mg Amlodipine/Candesartan cilexetil/Hydrochlorothiazide.
number: 14
text: A set of fixed dose pharmaceutical composition according to claim 12 or claim 13, wherein
number: 15
text: A process for the manufacture of a pharmaceutical composition according to one of the preceding claims, comprising the steps of:
Office action: search_report, dated 2017-09-20
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: EP0244944A2
ref_type: patent
severity: background
ref_id: EP0459136A1
ref_type: patent
severity: background
ref_id: US3163645A
ref_type: patent
severity: background
ref_id: CN101584700A
ref_type: patent
severity: background
ref_id: CN102342942A
ref_type: patent
severity: background
ref_id: CN102008483A
ref_type: patent
severity: background
ref_id: EP2165702A1
ref_type: patent
severity: background
ref_id: WO2014097209A1
ref_type: patent
severity: background
ref_id: EP1843754A1
ref_type: patent
severity: background
ref_id: EP2106789A1
ref_type: patent
severity: background
ref_id: CN101584700
ref_type: patent
severity: novelty_destroying
ref_id: CN102342942
ref_type: patent
severity: novelty_destroying
ref_id: CN102008483
ref_type: patent
severity: novelty_destroying
ref_id: EP2165702
ref_type: patent
severity: background
ref_id: WO2014097209
ref_type: patent
severity: background
ref_id: EP1843754
ref_type: patent
severity: background
ref_id: EP2106789
ref_type: patent
severity: background
Final disposition: pending (2017-09-20)