Composition for the Management of Nausea and Vomiting

摘要

A pharmaceutical dosage system comprising (a) an effective amount of one or more of Doxylamine, an analog thereof, a derivative thereof, a prodrug thereof, a metabolite thereof and/or a salt thereof; (b) an effective amount of one or more of (i) Pyridoxine, (ii) an analog thereof, (iii) a derivative thereof, (iv) a prodrug thereof, (v) a metabolite thereof and (vi) a salt of any of (i)-(v); and (c) an effective amount of one or more compounds of formula (I) wherein R is H, PO3 or. The system exhibits an improved pharmacokinetic profile relative to the current Diclectin®/Diclegis® formulation and is useful for example for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting of pregnancy (NVP).

主权项

1. A pharmaceutical dosage system comprising:
(a) from about 5 to about 40 mg of one or more of (i) Doxylamine and (ii) a pharmaceutically acceptable salt thereof; (b) from about 5 to about 80 mg of one or more of (i) a Pyridoxine compound of formula II, whereinR1 is a hydroxyl or phosphate group; andR2 is CH2OH, CHO, or CH2NH2; (ii) a pharmaceutically acceptable ester of (i); and (iii) a pharmaceutically acceptable salt of any of (i)-(ii); and (c) from about 20 to about 100 mg of one or more compounds of formula (I)wherein R is a hydroxyl group, a phosphate group oror a pharmaceutically acceptable salt thereof.