Improved Bioequivalence Assessment of Topical Dermatological Drug Products Using Dermatopharmacokinetics

N’Dri-Stempfer, Berthe; Navidi, William; Guy, Richard H.; Bunge, Annette L.

doi:10.1007/s11095-008-9742-9

Cited by 89 publications

(106 citation statements)

References 21 publications

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“…21,22 Four healthy volunteers (female, age 23-44 years), with no history of dermatological disease, participated in the study, which was approved by the Local Research Ethics Committee (Cerrahpaşa Medical Faculty Ethics Committee, Istanbul, Turkey). Written informed consent was obtained from each subject.…”

Section: In Vivo Skin Penetration Studymentioning

confidence: 99%

“…23 Then the stratum corneum was sequentially stripped from the same area, 20 times with adhesive tapes (Scotch Book Tape; 3M Tegaderm) in accordance with the published studies. [21][22][23][24] The adhesive tapes were applied to the skin with vigorous rubbing by the gloved operator and then removed. To check the skin barrier function, TEWL measurements were recorded using an open chamber device (Tewameter) before the first tape strip (baseline value) and during the tape stripping procedure.…”

Section: In Vivo Skin Penetration Studymentioning

confidence: 99%

See 1 more Smart Citation

Colloidal nanocarriers for the enhanced cutaneous delivery of naftifine: characterization studies and in vitro and in vivo evaluations

Erdal¹,

Özhan²,

Mat³

et al. 2016

IJN

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In topical administration of antifungals, the drugs should pass the stratum corneum to reach lower layers of the skin in effective concentrations. Thus, the formulation of antifungal agents into a suitable delivery system is important for the topical treatment of fungal infections. Nanosized colloidal carriers have gained great interest during the recent years to serve as efficient promoters of drug penetration into the skin. Microemulsions are soft colloidal nanosized drug carriers, which are thermodynamically stable and isotropic systems. They have been extensively explored for the enhancement of skin delivery of drugs. This study was carried out to exploit the feasibility of colloidal carriers as to improve skin transport of naftifine, which is an allylamine antifungal drug. The microemulsions were formulated by construction of pseudoternary phase diagrams and composed of oleic acid (oil phase), Kolliphor ® EL or Kolliphor ® RH40 (surfactant), Transcutol ® (cosurfactant), and water (aqueous phase). The plain and drug-loaded microemulsions were characterized in terms of isotropy, particle size and size distribution, pH value, refractive index, viscosity, and conductivity. The in vitro skin uptake of naftifine from microemulsions was studied using tape stripping technique in pig skin. The drug penetrated significantly into stratum corneum from microemulsions compared to its marketed cream ( P <0.05). Moreover, the microemulsion formulations led to highly significant amount of naftifine deposition in deeper layers of skin than that of commercial formulation ( P <0.001). Microemulsion–skin interaction was confirmed by attenuated total reflectance – Fourier transformed infrared spectroscopy data, in vitro. The results of the in vivo tape stripping experiment showed similar trends as the in vitro skin penetration study. Topical application of the microemulsion on human forearms in vivo enhanced significantly the distribution and the amount of naftifine penetrated into the stratum corneum as compared to the marketed formulation ( P <0.05). The relative safety of the microemulsion formulations was demonstrated with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide viability test. This study indicated that the nanosized colloidal carriers developed could be considered as an effective and safe topical delivery system for naftifine.

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Section: In Vivo Skin Penetration Studymentioning

confidence: 99%

Section: In Vivo Skin Penetration Studymentioning

confidence: 99%

Colloidal nanocarriers for the enhanced cutaneous delivery of naftifine: characterization studies and in vitro and in vivo evaluations

Erdal¹,

Özhan²,

Mat³

et al. 2016

IJN

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“…However, the drug concentration at each depth of the skin has been predicted using various mathematical equations [13][14][15][16][17][18]. We previously reported that the cutaneous disposition of topically applied drugs could be predicted using the difference method based on Fick's 2 nd law of diffusion, and also that the average drug concentration in the stratum corneum and viable epidermis/dermis could be determined separately [19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

Potential of imaging analysis in establishing skin concentration-distance profiles for topically applied FITC-dextran 4 kDa

Kijima¹,

Masaki²,

Kadhum³

et al. 2015

ADMET DMPK

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Quantitatively determining the skin concentration-distance profiles of topically applied drugs is important for evaluating their safety and efficacy. The aim of the present study was to quantitatively visualize the distribution of hydrophilic drugs through the skin using confocal laser scanning microscopy (CLSM) in order to obtain skin concentration-distance profiles. FITC-dextran with a molecular weight of approximately 4 kDa (FD-4) was selected as the model fluorescent drug in the present study, and excised pig ear skin was used. The skin concentration of FD-4 at each depth of a skin section was assessed by imaging analysis of the intensity of fluorescence. The FD-4 skin concentration-distance profile obtained was analyzed usingFick's second law of diffusion, and was markedly similar to that using skin permeation parameters in the skin permeation study. These results suggest that the present CLSM method may be a promising tool for quantitatively visualizing the concentration-distance profiles of drugs through the skin.

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“…Collaborative work has looked into the effect of epidermal turnover on percutaneous penetration [53], the clearance phase of the DPK profile [54] and into optimization of the DPK methods [55,56]. This work explored critical issues such as the time required for tape-stripping, cleaning procedures, and how the collected tape strips should be combined to reduce variability and improve analytical sensitivity.…”

Section: Dermatopharmacokineticsmentioning

confidence: 99%

Richard Guy and His Collaborators: ‘Crackling' the Skin Code

Delgado‐Charro

2013

Skin Pharmacol Physiol

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This paper aims to summarize the contributions of Richard Guy and collaborators to the skin field. Major contributions have been areas such as the modelling of skin absorption, use of spectroscopic techniques (Fourier transform infrared spectroscopy, attenuated total reflectance Fourier transform infrared spectroscopy and impedance spectroscopy) to characterize the skin barrier and the effects of enhancing techniques on the membrane, dermatopharmacokinetics and assessment of topical bio-availability, iontophoresis and reverse iontophoresis, and use of imaging techniques to elucidate pathways of penetration and the skin disposition of nanoparticles. The field of topical and transdermal drug delivery has benefitted incalculably from the extensive work of Guy and his group: their findings about mechanisms of drug delivery and permeation enhancement, and the development of methodologies which are now accepted as gold standards by skin scientists.

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Improved Bioequivalence Assessment of Topical Dermatological Drug Products Using Dermatopharmacokinetics

Abstract: Comparative bioequivalence can be assessed conclusively with fewer treatment sites in fewer subjects with robust methods that should be less sensitive to inter-laboratory differences.

Cited by 89 publications

References 21 publications

Colloidal nanocarriers for the enhanced cutaneous delivery of naftifine: characterization studies and in vitro and in vivo evaluations

Colloidal nanocarriers for the enhanced cutaneous delivery of naftifine: characterization studies and in vitro and in vivo evaluations

Potential of imaging analysis in establishing skin concentration-distance profiles for topically applied FITC-dextran 4 kDa

Richard Guy and His Collaborators: ‘Crackling' the Skin Code

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