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<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2d1 20170631//EN" "JATS-journalpublishing1.dtd">
      <JournalTitle>Journal of Asian Association of Schools of Pharmacy</JournalTitle>
      <Volume-Issue>Volume 1 No.1</Volume-Issue>
      <Season>January - March, 2012</Season>
      <ArticleTitle>An intravenous injection of melatonin: formulation, stability, pharmacokinetics and pharmacodynamics</ArticleTitle>
          <FirstName>Jeffrey Roy</FirstName>
          <FirstName>Nutjaree Prateepavanich</FirstName>
      <Abstract>Two different intravenous (IV) formulations for melatonin at strength of 5 mg/mL; one using 2- hydroxypropyl-B-cyclodextrin and propylene glycol to increase solubility and stability, and a second having additional antioxidant and chelating agent to reduce oxidation and hydrolysis were investigated. Both formulations were tested for clarity, pH stability, sterility, endotoxins, particulate matter according to US Pharmacopoeia Revision 31 (USP31), and photostability according to ICH guideline (ICH (Q1B), Option2), accelerated stability at 25o C/75% RH for 6 months, and real time stability for one year at 30o C/75%RH, according to IHC guidelines. The pharmacokinetics of the IV dose were investigated in Wistar rats, and the antioxidant effect determined ORAC analysis of rat plasma. Both formulations passed USP tests for purity and stability, although the formulation without antioxidant exhibited more color and pH change over the testing period. Formulation 2 showed expected pharmacodynamics on injection in rat (20 µg/200 µL/rat), and plasma showed a significant increase (p</Abstract>
      <Keywords>melatonin intravenous injection formulation stability pharmacokinetics</Keywords>
        <Abstract>https://aaspjournal.org/ubijournal-v1copy/journals/abstract.php?article_id=5911&amp;title=An intravenous injection of melatonin: formulation, stability, pharmacokinetics and pharmacodynamics</Abstract>
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