Development of a perillyl alcohol topical cream formulation

Abhishek Gupta, Paul B. Myrdal

Research output: Contribution to journalArticle

27 Scopus citations

Abstract

Perillyl alcohol (POH) is a relatively non-toxic agent that has been shown to be a promising anticancer monoterpene in preclinical models. Studies have indicated that topical application of POH may prove to be effective as a skin cancer chemoprevention therapy. The main aim of this study was to determine the influence of several factors on the stability of POH in solution and develop a topical formulation of POH. During preformulation, the influence of pH, temperature, ionic strength, and organic solvents, on the stability of POH was evaluated at four different temperatures: 4, 25, 37, and 48°C. POH was found to degrade under acidic conditions with degradation following apparent first-order kinetics. A hydrophilic topical cream formulation of POH was developed and prepared for toxicology and clinical studies. A reverse phase gradient HPLC method was developed to quantitate POH in the complex formulation. Stability studies of the formulation and a placebo were performed and the formulation was found to be physically and chemically stable over a period of 1 year at 4 and 25°C.

Original languageEnglish (US)
Pages (from-to)373-383
Number of pages11
JournalInternational Journal of Pharmaceutics
Volume269
Issue number2
DOIs
StatePublished - Jan 28 2004

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Keywords

  • Perillyl alcohol
  • Reverse phase HPLC assay
  • Stability
  • Topical cream formulation

ASJC Scopus subject areas

  • Pharmaceutical Science

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