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In Vitro Testing of Sunscreens for Dermal Absorption: Method Comparison and Rank Order Correlation with In Vivo Absorption.
Yang, Yang; Ako-Adounvo, Ann-Marie; Wang, Jiang; Coelho, Sergio G; Adah, Steven A; Matta, Murali K; Strauss, David; Michele, Theresa M; Wang, Jian; Faustino, Patrick J; O'Connor, Thomas; 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, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA. 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, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA.
  • Wang J; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA.
  • Coelho SG; Office of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.
  • Adah SA; Office of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.
  • Matta MK; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.
  • Strauss D; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.
  • Michele TM; Office of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.
  • Wang J; Office of Specialty Medicine, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, 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, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA.
  • O'Connor T; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA.
  • Ashraf M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, WO64-Rm1032, Silver Spring, Maryland, 20993, USA.
AAPS PharmSciTech ; 23(5): 121, 2022 Apr 22.
Article em En | MEDLINE | ID: mdl-35459978
Evaluating the dermal absorption of sunscreen UV filters requires the development of a bio-predictable in vitro permeation test (IVPT). This work describes the comparison of two IVPT methods and rank order correlations of in vitro absorption (skin permeation and retention) with the in vivo absorption (AUC and skin retention) of sunscreens. The IVPT was compared regarding the following elements: (1) application of a single finite dose vs. an infinite dose and (2) the use of heat-separated human epidermis vs. dermatomed skin models. The IVPT was used to evaluate dermal absorption of six UV filters (avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone) in commercial sunscreens. Both the in vivo and in vitro permeation studies demonstrated that all UV filters were absorbed following a single-dose application. Sunscreens were rank ordered by the amount of the UV filters absorbed. Data obtained from the IVPT method using a single finite dose and heat-separated human epidermis was found to correlate with the clinical data. Rank orders of the cumulative in vitro skin permeation and the in vivo AUC were found comparable for oxybenzone, homosalate, octisalate, and octinoxate. Rank orders of the in vitro and in vivo skin retention of oxybenzone and octinoxate were also comparable. Additional IVPT parameters may be optimized to enhance the discriminatory power for UV filters with low skin permeation potential (e.g., avobenzone and octocrylene).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Absorção Cutânea / Protetores Solares Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Absorção Cutânea / Protetores Solares Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article