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Current Drug Delivery

Volume 8 Issue 3
ISSN: 1567-2018
eISSN: 1875-5704

 

   All Titles

  Biphasic Vesicles for Topical Delivery of Interferon Alpha in Human Volunteers and Treatment of Patients with Human Papillomavirus Infections
  pp.307-319 (13) Authors: Marianna Foldvari, Ildiko Badea, Praveen Kumar, Shawn Wettig, Ravinder Batta, Martin J. King, Zhihong He, Emmanuel Yeboah, Kimberly Gaspar, Peter Hull, Neil H. Shear
 
 
      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
  Affiliation: School of Pharmacy, University of Waterloo, 200 University Avenue West, Waterloo, ON, Canada N2L 3G1.
 
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