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Risk evaluation of impurities in topical excipients:The acetol case

Journal of Pharmaceutical Analysis 2014年第5期4卷 303-315页

作者： Jente Boonen Lieselotte Veryser Lien Taevernier Nathalie Roche Kathelijne Peremans Christian Burvenich Bart De Spiegeleer Drug Quality and Registration (DruQuaR) Group Faculty of Pharmaceutical SciencesGhent UniversityHarelbekestraat 729000 GhentBelgium Department of Plastic and Reconstructive Surgery University Hospital GhentDe Pintelaan 185B-9000 GhentBelgium Department of Veterinary Medical Imaging and Small Animal Orthopaedics Faculty of Veterinary MedicineGhent UniversitySalisburylaan 133B-9820 MerelbekeBelgium Department of Comparative Physiology and Biometrics Faculty of Veterinary MedicineGhent UniversitySalisburylaan 133B-9820 MerelbekeBelgium

Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluated in-silico for their toxicity hazard. Acetol, an impurity likely present in different topical pharmaceutical excipients such as propylene glycol and glycerol, was withheld for the evaluation of its health risk after dermal exposure. 〈br〉 An ex-vivo in-vitro permeation study using human skin in a Franz Diffusion Cell set-up and GC as quantification methodology showed a significant skin penetration with an overall Kp value of 1.82 ？ 10 ？ 3 cm/h. Using these data, limit specifications after application of a dermal pharmaceutical product were estimated. Based on the TTC approach of Cramer class I substances, i.e. 1800 mg/（day？person）, the toxicity-qualified specification limits of acetol in topical excipients were calculated to be 90 mg/mL and 180 mg/mL for propylene glycol and glycerol, respectively.

关键词： Acetol Impurity Excipients transdermal penetration Specification limits

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Study on the Efficacy of Vitamin C Lotion on Skin: Permeable and Anti-Aging

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Journal of Cosmetics, Dermatological Sciences and Applications 2022年第1期12卷 67-82页

作者： Mengping Wang Wangwang Lu Xinye Ge Yuan Lu Xiwen Jia Huiming Li Qiaoyuan Liu R & D Department Galenic Cosmetics Laboratory SAS Paris France

Vitamin C (ascorbic acid) plays an important role in maintaining skin health, and topical vitamin C supplementation can counteract oxidative stress induced by UVA, due to excellent reducibility. To clarify the efficacy of vitamin C on the skin in the carrier of lotion, we studied its permeability, irritation and anti-aging effect in vitro and in vivo, using Franz cell system, cell model and clinical test. The permeability test showed that vitamin C with 10%, 15%, 20% and 25% mass ratio could effectively penetrate skin. The 20% of vitamin C lotion (VCL-20%) had the highest efficiency of transdermal penetration and the diffusion percentage reached 84.707% after 24 h. Besides, the permeation quantity of VCL-20% was 1.43 times that of the control group. Irritation test showed that the cytotoxicity of vitamin C lotion was low. And no allergic reaction happened in the occlusive patch test. Compared with the control group, using vitamin C lotion for 28 days could significantly improve subjects’ skin gloss of 10.53% and improve skin color, enhance facial skin elasticity and tightness of 9.20% and reduce wrinkle area of 12.27% (p < 0.05).

关键词： Vitamin C Lotion Efficacy transdermal penetration Skin Whitening Anti-Aging

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transdermal Study of Curcumin Solid Dispersion Microneedles in vitro

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Medicinal Plant 2021年第2期12卷 6-10页

作者： Jiao LUO Cong WANG Yuping MA Shengqian TIAN Jiayi DING Lili HE Department of Pharmacy Southwest Minzu University Chengdu 610041 China

[Objectives]To investigate the in vitro transdermal effect of curcumin solid dispersion needles prepared with povidone K 30(PVP K30),polyethylene glycol 6000(PEG 6000)and poloxamer 188(block polyether F68,poloxamer 188,F68)as carrier matrix,respectively.[Methods]Vertical Franz diffusion cell and HPLC method were used to detect the cumulative penetration and skin retention of the microneedles within 12 h.[Results]Within 12 h,the cumulative penetration of PVP K30 microneedles was as high as 7.098μg/cm2,and the skin retention reached 35.28μg/cm2;PEG 6000 and poloxamer 188 microneedles all showed good transdermal effect;while normal curcumin solid dispersion(control)had no obvious transdermal effect.[Conclusions]The transdermal penetration of curcumin is improved after prepared into solid dispersion microneedles,and among different matrixes,PVP K30 is the best choice.

关键词： Curcumin Solid dispersion Microneedle transdermal penetration

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