Use of Excised Human Skin to Assess the Bioequivalence of Topical Products

Franz, Thomas; Lehman, Paul A.; Raney, Sam G.

doi:10.1159/000235828

Cited by 116 publications

(90 citation statements)

References 28 publications

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“…Although infinite dose studies are a useful tool for comparing API flux from different formulations [18], the applied doses are substantially higher than those used by patients, and infinite dose experiments are therefore inappropriate when relevance to in vivo conditions is desired [19]. Test conditions that better mimic in vivo conditions are in vitro permeation experiments deploying a finite dose of the vehicle.…”

Section: Resultsmentioning

confidence: 99%

In vitro Skin Permeation and Penetration of Nonivamide from Novel Film-Forming Emulsions

Lunter

Daniels

2013

Skin Pharmacol Physiol

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The purpose of this study was to develop film-forming emulsions (FFE) facilitating long-term treatment of chronic pruritus with capsaicinoids. To this end, oil-in-water emulsions, which comprise dispersions of sustained-release polymers, were examined. Such emulsions form a film when applied to the skin and encapsulate the oily drug solution in a dry polymeric matrix. Permeation of the antipruritic drug nonivamide (NVA) is controlled by the matrix. Permeation rates of NVA from FFE and its concentration in the skin are equivalent to those achieved with a conventional semisolid formulation, but can be maintained for a longer period of time. FFE may therefore improve the treatment of chronic pruritus with capsaicinoids by enhancing patient compliance by means of a sustained-release regimen.

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Section: Resultsmentioning

confidence: 99%

In vitro Skin Permeation and Penetration of Nonivamide from Novel Film-Forming Emulsions

Lunter

Daniels

2013

Skin Pharmacol Physiol

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“…Amongst potentially suitable surrogates for in vivo clinical tests and studies of bioequivalence of topical products, there are in vitro dermatopharmacokinetics me-thods. The Franz cells system and ex vivo cutaneous microdialysis use respectively, dermal and epidermal layers of frozen skin fragments and a fresh fragment of the whole skin (skin explants) maintained in survival conditions in which the rate and extent of permeation through ex vivo skin, is measured [11] [12]. Previous studies showed that fresh skin explants maintained in survival conditions are useful for the ex vivo cutaneous absorption assessment of an active from a formulation [13] or the screening of the effects of topical corticosteroids [14].…”

Section: Discussionmentioning

confidence: 99%

Use of a Model of a Blood-Induced Bruise for the Evaluation of Formulations on Bruising

Robin¹,

Courderot-Masuyer²,

Tauzin³

et al. 2015

JCDSA

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Esthetic treatments can induce swelling and bruises. Thus, a treatment that would prevent or hasten the resolution of bruising should be very useful. Generally, the regression of bruising was conducted with patients or animals models. So we decided firstly to develop an ex vivo model in order to test antibruising properties of topical formulations and secondly to evaluate a curative effect of a cream (mixture of arnica extract and apigenin) in comparison with a positive control (vulnerary cream) and also to estimate the preventive interest of this cream. The results showed that the injection of 25 µl of blood into the dermis of skin fragments was sufficient to create a model of induced-bruise. The duration of 24 hours was chosen to compare the effects of actives on the decrease in the size of the bruise. Joint effects of a pretreatment and a treatment of a mixture of arnica extract and apigenin decreased significantly the area of bruising compared to the treatment group, the control group and the positive control group. Many topical products claim to improve bruising on their package label. Our model can demonstrate their efficacy and determinate the best topical antibruising formulation. The mechanism involved in anti-inflammatory activity of active compounds of topical formulations is often not fully understood. Our blood-induced model may bring some responses through the study of mediators of the inflammation.

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“…Furthermore, these chambers allow the skin to be maintained at a temperature and humidity that match normal in vivo conditions. Because of these characteristics, the Franz Skin Finite Dose Model has proven to accurately predict in vivo percutaneous absorption kinetics [7].…”

Section: Methodsmentioning

confidence: 99%

Evaluation of the in vitro Human Skin Percutaneous Absorption of Progesterone in Versabase® Using the Franz Skin Finite Dose Model

Bassani¹,

Banov²,

Carvalho³

2017

J Women's Health Care

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Women may benefit from hormone replacement therapy to alleviate undesirable menopausal symptoms such as hot flashes, disruption of sleep and fatigue. Transdermal hormone replacement therapy consists in the delivery of hormones through the skin and into the blood stream, avoiding gastrointestinal drug absorption difficulties and the first pass effect. Transdermal compounded medications may be customized to meet the individual needs of women by changing the hormones used, the respective concentrations and the medicine's formulation. Two compounded medications were prepared for progesterone 50 mg/g, as follows: Progesterone in VersaBase ® Cream and progesterone in VersaBase ® Cream Gel. The purpose of this study is to determine the in vitro human skin percutaneous absorption of progesterone for both test formulations. The Franz Skin Finite Dose Model was the methodology used to evaluate the total absorption, the rate of absorption and the skin content of progesterone applied to the outer surface of ex vivo skin. This model has proven to be a valuable tool for the study of percutaneous absorption of topically applied drugs and to accurately predict in vivo permeation kinetics. The skin samples were obtained within 24 h to 48 h of death from three adult Caucasian donors and a total of 17 Franz diffusion chambers were prepared for testing. Results are presented as the mean ± standard error per parameter, for each test formulation. The rate of percutaneous absorption, presented as mean flux, was similar for the two test formulations and characterized by 2 peaks at approximately 6 hours and 28 hours after dose application, followed by a decline in flux over time. The total absorption and the skin content of progesterone were also similar: 21.6% and 21.8% of the applied doses for the test formulations 1 and 2, respectively. Although in vitro, these results suggest that progesterone in VersaBase ® is likely to be delivered through the skin and into the general circulation for systemic effects. Practitioners may then consider transdermal progesterone as a viable route of drug administration for menopausal women.

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Use of Excised Human Skin to Assess the Bioequivalence of Topical Products

Cited by 116 publications

References 28 publications

In vitro Skin Permeation and Penetration of Nonivamide from Novel Film-Forming Emulsions

In vitro Skin Permeation and Penetration of Nonivamide from Novel Film-Forming Emulsions

Use of a Model of a Blood-Induced Bruise for the Evaluation of Formulations on Bruising

Evaluation of the in vitro Human Skin Percutaneous Absorption of Progesterone in Versabase® Using the Franz Skin Finite Dose Model

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