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An intravenous injection of melatonin: formulation, stability, pharmacokinetics and pharmacodynamics
Jeffrey Roy Johns, Chatchawan Chenboonthai, Nutjaree Prateepavanich Johns, Aucharaporn Saengkrasat, Ratiya Kuketpitakwong and Supatra Porasupatana
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 25oC/75% RH for 6 mo, and real time stability for one year at 30oC/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<0.05) of ORAC antioxidant capacity from 10 min after injection. This study provides evidence of suitable intravenous formulations of melatonin for bioavailability or studies.
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An intravenous injection of melatonin: formulation, stability, pharmacokinetics and pharmacodynamics
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