Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof

  • US 9,089,489 B2
  • Filed: 03/27/2014
  • Issued: 07/28/2015
  • Est. Priority Date: 02/22/2012
  • Status: Active Grant
First Claim
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1. A dual release oral dosage form comprising:

  • (A) an immediate release composition comprising;

    (a) from about 5 mg to about 20 mg of doxylamine and/or a pharmaceutically acceptable salt thereof; and

    (b) from about 5 mg to about 20 mg of pyridoxine and/or a pharmaceutically acceptable salt thereof; and

    (B) a delayed release composition comprising;

    (a) from about 5 mg to about 20 mg of doxylamine and/or a pharmaceutically acceptable salt thereof; and

    (b) from about 5 mg to about 20 mg of pyridoxine and/or a pharmaceutically acceptable salt thereof;

    wherein said immediate release composition is for effecting release of (a) doxylamine and/or pharmaceutically acceptable salt thereof and (b) pyridoxine and/or pharmaceutically acceptable salt thereof, which begins prior to release of (a) doxylamine and/or pharmaceutically acceptable salt thereof and (b) pyridoxine and/or pharmaceutically acceptable salt thereof, from the delayed release component, within the gastrointestinal tract.

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