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Combination of retinyl palmitate and UV-filters: phototoxic risk assessment based on photostability and in vitro and in vivo phototoxicity assays.
Eur J Pharm Sci. 2015 Feb 20; 68:127-36.EJ

Abstract

This study aimed to assess the phototoxic potential of combined UV-filters and retinyl palmitate (RP) in the presence or not of bemotrizinol (BMTZ), employing photostability and in vitro and in vivo phototoxicity assays. The formulations tested contained octocrylene (OCT), octyl methoxycinnamate (OMC), benzophenone-3 (BZP-3) and RP (photostable) or octocrylene (OCT), octyl methoxycinnamate (OMC), avobenzone (AVO) and RP (less photostable). Both formulations were supplemented with bemotrizinol. Photostability was evaluated by exposing, or not, formulations spread on a glass plate to UVA/UVB irradiation. The resulting products were quantified by HPLC analysis. In vitro phototoxicity of UV-filters and combinations were evaluated using 3T3 viable monolayer fibroblast cultures submitted, or not, to irradiation according to OECD TG 432. In vivo photoallergy and photoxicity were assessed by clinical studies (photopatch test). Photostability assays showed that UV-filter bemotrizinol was a better photostabilizer for RP/benzophenone-3 than for RP/avobenzone. The in vitro phototoxicity of the combination RP/avobenzone was reduced by bemotrizinol. Clinical studies did not indicate phototoxic or photoallergenic potentials in all formulations tested. It is concluded that the 3T3 NRU phototoxicity test may be considered a supplementary assay in formulation developments, since it can detect chemically unstable and potentially phototoxic combinations. However, extrapolation of in vitro positive results to human photopatch tests may be performed only to a limited extent.

Authors+Show Affiliations

Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo, Sao Paulo, Brazil.Allergisa - Investiga Research Institute, Barao Geraldo, Campinas, Sao Paulo, Brazil.Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: lorena@fcfrp.usp.br.

Pub Type(s)

Controlled Clinical Trial
Journal Article

Language

eng

PubMed ID

25533240

Citation

Benevenuto, Carolina Gomes, et al. "Combination of Retinyl Palmitate and UV-filters: Phototoxic Risk Assessment Based On Photostability and in Vitro and in Vivo Phototoxicity Assays." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 68, 2015, pp. 127-36.
Benevenuto CG, Guerra LO, Gaspar LR. Combination of retinyl palmitate and UV-filters: phototoxic risk assessment based on photostability and in vitro and in vivo phototoxicity assays. Eur J Pharm Sci. 2015;68:127-36.
Benevenuto, C. G., Guerra, L. O., & Gaspar, L. R. (2015). Combination of retinyl palmitate and UV-filters: phototoxic risk assessment based on photostability and in vitro and in vivo phototoxicity assays. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 68, 127-36. https://doi.org/10.1016/j.ejps.2014.12.007
Benevenuto CG, Guerra LO, Gaspar LR. Combination of Retinyl Palmitate and UV-filters: Phototoxic Risk Assessment Based On Photostability and in Vitro and in Vivo Phototoxicity Assays. Eur J Pharm Sci. 2015 Feb 20;68:127-36. PubMed PMID: 25533240.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination of retinyl palmitate and UV-filters: phototoxic risk assessment based on photostability and in vitro and in vivo phototoxicity assays. AU - Benevenuto,Carolina Gomes, AU - Guerra,Lucas Offenbecker, AU - Gaspar,Lorena Rigo, Y1 - 2014/12/19/ PY - 2014/03/18/received PY - 2014/12/04/revised PY - 2014/12/04/accepted PY - 2014/12/24/entrez PY - 2014/12/24/pubmed PY - 2015/9/18/medline KW - Bemotrizinole KW - Photoallergenicity KW - Photostability KW - Phototoxicity KW - Retinyl palmitate KW - UV-filters SP - 127 EP - 36 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 68 N2 - This study aimed to assess the phototoxic potential of combined UV-filters and retinyl palmitate (RP) in the presence or not of bemotrizinol (BMTZ), employing photostability and in vitro and in vivo phototoxicity assays. The formulations tested contained octocrylene (OCT), octyl methoxycinnamate (OMC), benzophenone-3 (BZP-3) and RP (photostable) or octocrylene (OCT), octyl methoxycinnamate (OMC), avobenzone (AVO) and RP (less photostable). Both formulations were supplemented with bemotrizinol. Photostability was evaluated by exposing, or not, formulations spread on a glass plate to UVA/UVB irradiation. The resulting products were quantified by HPLC analysis. In vitro phototoxicity of UV-filters and combinations were evaluated using 3T3 viable monolayer fibroblast cultures submitted, or not, to irradiation according to OECD TG 432. In vivo photoallergy and photoxicity were assessed by clinical studies (photopatch test). Photostability assays showed that UV-filter bemotrizinol was a better photostabilizer for RP/benzophenone-3 than for RP/avobenzone. The in vitro phototoxicity of the combination RP/avobenzone was reduced by bemotrizinol. Clinical studies did not indicate phototoxic or photoallergenic potentials in all formulations tested. It is concluded that the 3T3 NRU phototoxicity test may be considered a supplementary assay in formulation developments, since it can detect chemically unstable and potentially phototoxic combinations. However, extrapolation of in vitro positive results to human photopatch tests may be performed only to a limited extent. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/25533240/Combination_of_retinyl_palmitate_and_UV_filters:_phototoxic_risk_assessment_based_on_photostability_and_in_vitro_and_in_vivo_phototoxicity_assays_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(14)00447-3 DB - PRIME DP - Unbound Medicine ER -