Patent ID: 7704527

Claim:
A milnacipran formulation comprising: (a) an extended release core comprising milnacipran, or a pharmaceutically acceptable salt thereof and one or more extended release excipients; and (b) a coating around the extended release core, said coating comprising a delayed release excipient; wherein: (i) the coating delays the rise in milnacipran blood plasma concentration for at least half-an-hour after administration to a patient in need thereof and causes the formulation to release in vitro less than 10% of the milnacipran over the first two hours measured in 0.1 N HCl; (ii) the extended release core allows a reduction in dosing frequency as compared to an immediate release dosage form; provides, upon administration to a human subject, a T max of about 6-10 hours; and produces therapeutically effective plasma levels over approximately 24 hours when administered to a patient in need thereof; and (iii) the formulation provides a diminished incidence or reduced intensity of one or more side effects effected by immediate release milnacipran.