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Related Experiment Videos

Preformulation study of pelrinone hydrochloride.

J Hajdu1, G Adams, H K Lee

  • 1Pharmacy Research and Development, Wyeth-Ayerst Research, Rouses Point, NY 12979.

Journal of Pharmaceutical Sciences
|November 1, 1988
PubMed
Summary

Pelrinone HCl exhibits unique pH-solubility and partition coefficient profiles. This compound demonstrates stability in solution and solid states, with polymorphs identified, but shows incompatibility with povidone.

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Area of Science:

  • Pharmaceutical Chemistry
  • Physical Chemistry

Background:

  • Understanding the physicochemical properties of pharmaceutical compounds is crucial for formulation development.
  • Pelrinone HCl's characteristics, including hygroscopicity, solubility, and stability, require thorough investigation.

Purpose of the Study:

  • To characterize the physicochemical properties of Pelrinone HCl.
  • To evaluate its stability under various conditions and its compatibility with common excipients.

Main Methods:

  • pH-solubility and octanol-water partition coefficient-pH profiling.
  • Ionization pKa determination.
  • Ionic strength effect studies.
  • Excipient compatibility testing.
  • Polymorphism analysis using solubility phase diagrams, X-ray diffraction, and IR spectroscopy.

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  • Stability studies in solution and solid state under light and thermal stress.

    • Main Results:

    • Pelrinone HCl is nonhygroscopic with U-shaped pH-solubility and bell-shaped partition coefficient-pH profiles.
    • Two ionizable functions with pKa values of 4.71 and 8.94 were identified.
    • Solubility shows variable ionic strength dependence based on pH.
    • Povidone was found to be incompatible; other excipients showed no gross incompatibility.
    • Polymorphism was confirmed.
    • Pelrinone HCl demonstrated good stability in solution and solid states under tested conditions.

    Conclusions:

    • Pelrinone HCl possesses distinct physicochemical properties influencing its behavior in different environments.
    • The compound is stable and exhibits polymorphism, necessitating careful formulation considerations.
    • Incompatibility with povidone should be noted during drug product development.