title: In Vitro Drug Transfer Due to Drug Retention in Human Epidermis Pretreated with Application of Marketed Estradiol Transdermal Systems.
abstract: Study objective was to assess skin-to-skin drug transfer potential that may occur due to drug retention in human epidermis (DRE) pretreated with application of estradiol transdermal drug delivery systems (TDDS) and other estradiol transdermal dosage forms (gels and sprays). TDDS (products-A, B, and C) with varying formulation design and composition, and other estradiol transdermal products (gel and spray) were applied to heat separated human epidermis (HSE) and subjected to in vitro drug permeation study. Amounts of DRE were quantified after 24 h. The DRE with product-B was significantly (P < 0.001) higher than that with product-C, product-A, gel, and spray. However, products-A and C, gel, and spray showed almost the same (P > 0.05) amounts of DRE. A separate in vitro permeation study was carried out to determine amounts of drug transferred from drug-retaining epidermis to untreated HSE. The amounts of drug transferred, due to DRE after 8 h, with product-C were significantly (P < 0.001) higher than those with products-A and B, gel, and spray. The in vitro study results indicate a high potential of skin-to-skin drug transfer due to the DRE after labeled period of using estradiol TDDS, though the clinical relevance of these findings is yet to be determined.
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. krishnaiah.yellela@fda.hhs.gov.
authors.forename: Yellela S R
authors.initials: YSR
authors.lastname: Krishnaiah
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Naresh
authors.initials: N
authors.lastname: Pavurala
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Yang
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Prashanth
authors.initials: P
authors.lastname: Manda
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Usha
authors.initials: U
authors.lastname: Katragadda
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Yongsheng
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Rakhi
authors.initials: R
authors.lastname: Shah
authors.affiliation: Division of Bone, Reproductive and Urology Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Guodong
authors.initials: G
authors.lastname: Fang
authors.affiliation: Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.|Rangel College of Pharmacy, Texas A&M University Health Science Center, College Station, Texas, USA.
authors.forename: Mansoor A
authors.initials: MA
authors.lastname: Khan
mesh_terms: D000279:Administration, Cutaneous; D016503:Drug Delivery Systems / Q000379:methods; D004817:Epidermis / Q000502:physiology; D004958:Estradiol / Q000008:administration & dosage / Q000494:pharmacology; D004967:Estrogens / Q000008:administration & dosage / Q000494:pharmacology; D005782:Gels / Q000008:administration & dosage; D006801:Humans; D012869:Skin Absorption
chemical_list: D004967:Estrogens; D005782:Gels; D004958:Estradiol
keywords: drug delivery; drug retained in epidermis (DRE); estradiol; human epidermis; skin-to-skin transfer; transdermal