An innovative topical drug formulation for wound healing and infection treatment: in vitro and in vivo investigations of a povidone-iodine liposome hydrogel.
BACKGROUND
In topical wound treatment, the combination of anti-infectious therapy and a healing-promoting moisturization has not been accomplished yet.


OBJECTIVE
Evaluation of a new topical drug consisting of a povidone-iodine (PVP-I) liposome hydrogel allowing for both antiseptic and moist treatment.


METHODS
Pharmaceutical formulation of a complex of PVP-I (3%) and phosphatidylcholine in a hydrogel. In vitro, interaction of the complex with relevant micro-organisms was analysed by electron microscopy. Antimicrobial activity was investigated using Staphylococcus aureus in a suspension test. Tissue toxicity was examined by an explantation test in a rodent model. A randomized clinical study on efficacy and tolerability in wound healing was carried out on 35 patients with mesh grafts in parallel groups (PVP-I liposome hydrogel vs. Bactigras) for proof of concept in humans.


RESULTS
A direct interaction of the PVP-I liposomes with micro-organisms by attachment to the cell surface was documented. A significantly better microbicidal activity and tissue tolerability of the PVP-I liposome hydrogel compared to conventional PVP-I formulations was shown. The results of the clinical study, especially measurements of neo-epithelization per time and transplant loss, demonstrate significant differences in favour of the PVP-I liposome hydrogel.


CONCLUSIONS
The novel PVP-I liposome hydrogel combines microbicidal and wound healing activities resulting in enhanced epithelization.
Reimer
K
K
Mundipharma GmbH, Limburg, Germany. Karen.Reimer@Mundipharma.de
Vogt
P M
PM
Broegmann
B
B
Hauser
J
J
Rossbach
O
O
Kramer
A
A
Rudolph
P
P
Bosse
B
B
Schreier
H
H
Fleischer
W
W
D000891:Anti-Infective Agents, Local / Q000494:pharmacology*; D002176:Candida albicans / Q000187:drug effects / Q000648:ultrastructure; D002626:Chemistry, Pharmaceutical; D004926:Escherichia coli / Q000187:drug effects / Q000648:ultrastructure; D005260:Female; D006801:Humans; D020100:Hydrogels; D008081:Liposomes; D008297:Male; D008826:Microbial Sensitivity Tests; D008854:Microscopy, Electron; D011206:Povidone-Iodine / Q000494:pharmacology*; D012867:Skin / Q000187:drug effects / Q000473:pathology; D012874:Skin Diseases, Infectious / Q000382:microbiology / Q000517:prevention & control*; D016038:Skin Transplantation; D013211:Staphylococcus aureus / Q000187:drug effects; D014945:Wound Healing / Q000187:drug effects*
D000891:Anti-Infective Agents, Local; D020100:Hydrogels; D008081:Liposomes; D011206:Povidone-Iodine