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In Vitro Testing of Sunscreens for Dermal Absorption: A Platform for Product Selection for Maximal Usage Clinical Trials.
Yang, Yang; Ako-Adounvo, Ann-Marie; Wang, Jiang; Zhang, Jinhui; Willett, Daniel; Yilmaz, Huzeyfe; Korang-Yeboah, Maxwell; Hsu, Hao-Jui; Wang, Jian; Coelho, Sergio G; Adah, Steven A; Michele, Theresa M; Faustino, Patrick J; Cruz, Celia N; Lee, Sau; Ashraf, Muhammad.
Afiliação
  • Yang Y; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA. Electronic address: yang.yang@fda.hhs.gov.
  • Ako-Adounvo AM; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Wang J; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Zhang J; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Willett D; Division of Complex Drug Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Missouri, USA.
  • Yilmaz H; Division of Complex Drug Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Missouri, USA.
  • Korang-Yeboah M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Hsu HJ; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Wang J; Office of Drug Evaluation IV, Office New Drugs, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Coelho SG; Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office New Drugs, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Adah SA; Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office New Drugs, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Michele TM; Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office New Drugs, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Faustino PJ; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Cruz CN; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Lee S; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
  • Ashraf M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Maryland, USA.
J Invest Dermatol ; 140(12): 2487-2495, 2020 12.
Article em En | MEDLINE | ID: mdl-32353451
Sunscreen products contain UV filters as active ingredients for the protection of the skin against UVR. The US Food and Drug Administration (FDA) issued a new proposed rule in 2019 (84.FR.6204) for sunscreens and identified the need for additional safety data for certain UV filters including their dermal absorption data. Dermal absorption data reveal systemic exposure of UV filters in humans, which can be obtained from clinical maximal usage trials. FDA guidance recommends conducting in vitro skin permeation tests (IVPTs) to help select formulations for maximal usage clinical trials as IVPT results may be indicative of in vivo absorption. This case study reports in vitro methodologies used for the selection of sunscreen products for an FDA-sponsored proof-of-concept maximal usage clinical trial. An IVPT method was developed using human cadaver skin. Commercially available sunscreen products were tested to determine the skin absorption potential of common UV filters using the IVPT. All the studied sunscreen products demonstrated a certain degree of skin absorption of UV filters using IVPT, and a formulation rank order was obtained. These sunscreen products were also characterized for several formulation properties including the globule size in emulsions, which was found to be an indicator for the rank order.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pele / Absorção Cutânea / Protetores Solares / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Aged / Aged80 / Female / Humans País como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pele / Absorção Cutânea / Protetores Solares / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Aged / Aged80 / Female / Humans País como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article