Biphasic Vesicles for Topical Delivery of Interferon Alpha in Human Volunteers and Treatment of Patients with Human Papillomavirus Infections

Author(s): Marianna Foldvari , Ildiko Badea , Praveen Kumar , Shawn Wettig , Ravinder Batta , Martin J. King , Zhihong He , Emmanuel Yeboah , Kimberly Gaspar , Peter Hull , Neil H. Shear .

Journal Name: Current Drug Delivery

Volume 8 , Issue 3 , 2011

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Abstract:

Purpose: Topical biphasic vesicle delivery system encapsulating interferon alpha (IFN α) was developed as an alternative to injections used to treat human papillomavirus (HPV) infections. Methods: Biphasic lipid vesicles encapsulating increasing doses of IFN α (biphasic IFN α) were characterized for encapsulation efficiency, size, zeta potential and vesicle structure by centrifugation, dynamic light scattering, confocal microscopy and small-angle x-ray scattering. Biphasic IFNα delivery into human skin in vivo and topical efficacy in patients with genital warts were evaluated. Results: Average encapsulation efficiency of IFN α was 81-91%. The average particle size was 1000-1100 nm and zeta potential +70 to +78 mV. After application of 5, 15 and 40MU/g biphasic IFN α formulation in a topical patch on the upper inner arm in healthy volunteers, skin IFN α levels increased to 120±30, 380±60 and 400±80 IU/mg protein in skin homogenates (n=5, 5, and 7), respectively. Topical application of biphasic IFN α (1 MU/dose) twice daily for two weeks in a pilot study with 12 patients with external condylomata acuminata resulted in a decrease in lesion size, in 2,5-oligoadenylate synthetase activity and in tissue viral load. Conclusions: Biphasic vesicles delivered clinically significant levels of IFN α across intact human skin and elicited marked therapeutic effect in patients.

Keywords: Topical delivery, protein delivery, biphasic vesicles, interferon alpha, genital warts, HPV, Papillomavirus, IFN, zeta potential, confocal microscopy

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Article Details

VOLUME: 8
ISSUE: 3
Year: 2011
Page: [307 - 319]
Pages: 13
DOI: 10.2174/156720111795256129
Price: $58

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