title: Biocompatibility of components of a female controlled drug delivery system.
abstract: A female controlled drug delivery system (FcDDS) containing sodium dodecyl sulfate as a microbicide, ethylenediaminetetraacetic acid (EDTA) as a synergistic microbicide, and lactic acid as a pH modulator was developed as an intravaginal barrier device against sexually transmitted diseases. The host response of the vagina to the FcDDS was evaluated through biocompatibility tests including cell viability, estrogenicity, and cytotoxicity assays on HeLa cervical cells and NIH:Ovcar-3 ovarian cells. Gel electrophoresis and reverse transcriptase polymerase chain reaction assays on HeLa cervical cell lines were also performed to elucidate the effects of EDTA on the expression of particular proteins of interest. The results of the cell viability test showed no significant difference in viability of cells upon exposure to EDTA at concentrations less than 0.035% that was reported to exert spermicidal activity. EDTA at concentrations less than 0.035% did not cause any cytotoxicity. The results of reverse transcriptase polymerase chain reaction analysis revealed that EDTA induced the expression of a 67-kDa protein in HeLa cells, which was identified as elastin binding protein (a part of the elastin receptor complex). This work has demonstrated that FcDDS containing EDTA is biocompatible and safe to be used as an intravaginal barrier device.
authors.affiliation: Department of Pharmaceutics, Division of Pharmaceutical Sciences, University of Missouri School of Pharmacy, 5005 Rockhill Road, Katz Building #108, Kansas City, MO 64110-2499, USA.
authors.forename: Bharat K
authors.initials: BK
authors.lastname: Warrier
authors.forename: Elisabet
authors.initials: E
authors.lastname: Kostoryz
authors.forename: Chi H
authors.initials: CH
authors.lastname: Lee
mesh_terms: D001672:Biocompatible Materials; D045744:Cell Line, Tumor; D049109:Cell Proliferation / Q000187:drug effects; D002470:Cell Survival / Q000187:drug effects; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004492:Edetic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000633:toxicity; D005260:Female; D006801:Humans; D019344:Lactic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000633:toxicity; D009573:Nitrites / Q000378:metabolism; D011956:Receptors, Cell Surface / Q000235:genetics; D012967:Sodium Dodecyl Sulfate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000633:toxicity
chemical_list: D001672:Biocompatible Materials; D009573:Nitrites; D011956:Receptors, Cell Surface; C054901:elastin-binding proteins; D019344:Lactic Acid; D012967:Sodium Dodecyl Sulfate; D004492:Edetic Acid