EP 1556024 A4 20070117 - PULSATILE RELEASE COMPOSITIONS OF MILNACIPRAN

Title (en)

PULSATILE RELEASE COMPOSITIONS OF MILNACIPRAN

Title (de)

ZUSAMMENSETZUNGEN VON MILNACIPRAN MITPULSATIVER FREISETZUNG

Title (fr)

COMPOSITIONS A LIBERATION INTERMITTENTE DE MILNACIPRANE

Publication

EP 1556024 A4 20070117 (EN)

Application

EP 03809957 A 20031022

Priority

US 0333685 W 20031022
US 42164002 P 20021025
US 43162602 P 20021205
US 43162702 P 20021205
US 43186102 P 20021209
US 43190602 P 20021209
US 44361803 P 20030129
US 45899403 P 20030328
US 45899503 P 20030328
US 45906103 P 20030328

Abstract (en)

[origin: WO2004039361A1] A once-a-day oral milnacipran pulsatile release composition has been developed that releases the drug in spaced apart "pulses". The dosage forms are comprised of first, second and optional third dosage units, with each dosage unit having a different drug release profile. This dosage form provides in vivo drug plasma levels characterized by Cmax below 3000 ng/ml, preferably below 2000 ng/ml, and most preferably below 1000 ng/ml. These levels help to avoid stimulation of the cholinergic effects on the CNS. The composition allows milnacipran to be delivered over approximately 24 hours, when administered to a patient in need, resulting in diminished incidence or decreased intensity of common milnacipran side effects such as sleep disturbance, nausea, vomiting, headache, tremulousness, anxiety, panic attacks, palpitations, urinary retention, orthostatic hypotension, diaphoresis, chest pain, rash, weight gain, back pain, constipation, vertigo, increased sweating, agitation, hot flushes, tremors, fatigue, somnolence, dyspepsia, dysoria, nervousness, dry mouth, abdominal pain, irritability, and insomnia.

IPC 8 full level

A61K 47/48 (2006.01); A61K 9/16 (2006.01); A61K 9/22 (2006.01); A61K 9/24 (2006.01); A61K 9/48 (2006.01); A61K 9/50 (2006.01); A61K 31/12 (2006.01); A61K 31/55 (2006.01); A61K 9/20 (2006.01); A61K 9/28 (2006.01)

CPC (source: EP)

A61K 9/4808 (2013.01); A61K 9/2054 (2013.01); A61K 9/2059 (2013.01); A61K 9/2846 (2013.01)

Citation (search report)

[DX] WO 9808495 A1 19980305 - PF MEDICAMENT [FR], et al
[A] WO 0040224 A1 20000713 - ELAN CORP PLC [IE], et al
[Y] WO 9959593 A1 19991125 - LILLY CO ELI [US], et al
[Y] EP 0759299 A1 19970226 - LILLY CO ELI [US]
[E] WO 2004067039 A1 20040812 - COLLEGIUM PHARMACEUTICAL INC [US], et al
[E] WO 2004037190 A2 20040506 - COLLEGIUM PHARMACEUTICAL INC [US]
[PX] JP 2003277252 A 20031002 - ASAHI KASEI CORP
See references of WO 2004039361A1

Designated contracting state (EPC)

AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LI LU MC NL PT RO SE SI SK TR

DOCDB simple family (publication)

WO 2004039361 A1 20040513; AU 2003301762 A1 20040525; AU 2003301762 B2 20060209; CA 2503121 A1 20040513; EP 1556024 A1 20050727; EP 1556024 A4 20070117; JP 2006506461 A 20060223; MX PA05004422 A 20071122

DOCDB simple family (application)

US 0333685 W 20031022; AU 2003301762 A 20031022; CA 2503121 A 20031022; EP 03809957 A 20031022; JP 2005501896 A 20031022; MX PA05004422 A 20031022