Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Solubility and Physicochemical Stability of Ondansetron Hydrochloride in Various Vehicles

용제 중 염산온단세트론의 용해성 및 안정성

  • Gwak, Hye-Sun (College of Pharmacy, Chosun University) ;
  • Oh, Ik-Sang (College of Pharmacy, Dongduk Women's University) ;
  • Chun, In-Koo (College of Pharmacy, Dongduk Women's University)
  • 곽혜선 (조선대학교 약학대학) ;
  • 오익상 (동덕여자대학교 약학대학) ;
  • 전인구 (동덕여자대학교 약학대학)
  • Published : 2003.03.20
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Abstract

The solubility and stability of ondansetron hydrochloride (OS) in various vehicles were determined. The effect of cyclodextrins (CD) on the solubility of OS in water was determined by equilibrium solubility method. The solubility of OS at $32^{\circ}C$ increased in the rank order of isopropyl myristate (IPM) < propylene glycol laurate (PGL) ${\ll}$ propylene glycol monolaurate < propylene glycol monocaprylate (PGMC) < poly(ethylene glycol) 400 < diethylene glycol mono ethyl ether (DGME) < ethanol < poly(ethylene glycol) 300 < water (36.1 mg/ml) ${\ll}$ propylene glycol (PG) (283 mg/ml). The addition of PG or DGME to non-aqueous vehicles such as IPM, PGL and PGMC markedly increased the solubility of OS. The addition of CDs in water increased the solubility. Apparent stability constant for the CD complexation with OS was calculated to be $25.5\;M^{-1}$ for $2-hydroxypropyl-{\beta}-CD\;(2HP{\beta}CD)$. Twenty mM ${\beta}-CD$, 69.4 mM sulfobutyl ether ${\beta}-CD$ and 115.4 mM $2HP{\beta}CD$ increased the aqueous solubilty of OS 1.27, 2.18 and 1.85 times, respectively. OS was stable in buffered aqueous solution (pH 5.0). However, OS was relatively unstable in non-aqueous vehicles in the order of PG

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References

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