Title:
ミルナシプランのパルス型放出組成物
Document Type and Number:
Japanese Patent JP2006506461
Kind Code:
A
Abstract:
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.
Inventors:
Hirsh, Jane
Larry, Roman buoy.
Hefanan michael
Larry, Roman buoy.
Hefanan michael
Application Number:
JP2005501896A
Publication Date:
February 23, 2006
Filing Date:
October 22, 2003
Export Citation:
Assignee:
Corzium Pharmaceutical, Incorporated
International Classes:
A61K31/165; A61K9/16; A61K9/22; A61K9/24; A61K9/28; A61K9/48; A61K9/50; A61K31/12; A61K31/55; A61K45/00; A61K9/20
Domestic Patent References:
| JP2000516946A | 2000-12-19 | |||
| JPH08500834A | 1996-01-30 | |||
| JP2002515435A | 2002-05-28 | |||
| JP2001526213A | 2001-12-18 |
Foreign References:
| WO2001013898A2 | 2001-03-01 | |||
| WO2001087284A2 | 2001-11-22 | |||
| WO2000059479A1 | 2000-10-12 | |||
| WO2001000181A2 | 2001-01-04 |
Attorney, Agent or Firm:
Hidesaku Yamamoto
Takaaki Yasumura
Natsuki Morishita
Takaaki Yasumura
Natsuki Morishita