TY - JOUR
T1 - Development of a perillyl alcohol topical cream formulation
AU - Gupta, Abhishek
AU - Myrdal, Paul B.
N1 - Funding Information:
This work was partially supported by USPHS Grant #CA27502. We acknowledge James Blanchard, Ph.D. for his assistance in the early formulation development.
PY - 2004/1/28
Y1 - 2004/1/28
N2 - 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.
AB - 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.
KW - Perillyl alcohol
KW - Reverse phase HPLC assay
KW - Stability
KW - Topical cream formulation
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U2 - 10.1016/j.ijpharm.2003.09.026
DO - 10.1016/j.ijpharm.2003.09.026
M3 - Article
C2 - 14706249
AN - SCOPUS:0347990424
SN - 0378-5173
VL - 269
SP - 373
EP - 383
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 2
ER -