Comparison of Skin Stripping, in vitro Release, and Skin Blanching Response Methods to Measure Dose Response and Similarity of Triamcinolone Acetonide Cream Strengths from Two Manufactured Sources

Pershing, Lynn K.; Bakhtian, Shahrzad; Poncelet, Craig E.; Corlett, Judy L.; Shah, Vinod P.

doi:10.1002/jps.10147

Cited by 44 publications

(27 citation statements)

References 14 publications

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“…The balance between red (100)/green (−100) and yellow (100)/blue (−100) is represented by "a" and "b", respectively. 40 Blanching effect that expected to be formed after administration of formulation on male albino Wistar rat skin was measured with the chromameter, and the results were correlated to the results of ex-vivo permeation studies. The difference in color (∆a) between the gel-treated site and the untreated site as the control were described.…”

Section: Skin Blanching Assaymentioning

confidence: 99%

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Özcan¹,

Azizoğlu²,

Şenyiğit³

et al. 2013

IJN

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Abstract:The objective of this study was to prepare a suitable formulation for dermal delivery of diflucortolone valerate (DFV) that would maintain the localization in skin layers without any penetration and to optimize efficiency of DFV. Drug-loaded lecithin/chitosan nanoparticles with high entrapment efficiency (86.8%), were successfully prepared by ionic interaction technique. Sustained release of DFV was achieved without any initial burst release. Nanoparticles were also incorporated into chitosan gel at different ratios for preparing a more suitable formulation for topical drug delivery with adequate viscosity. In ex-vivo permeation studies, nanoparticles increased the accumulation of DFV especially in the stratum corneum + epidermis of rat skin without any significant permeation. Retention of DFV from nanoparticle in chitosan gel formulation (0.01%) was twofold higher than commercial cream, although it contained ten times less DFV. Nanoparticles in gel formulations produced significantly higher edema inhibition in rats compared with commercial cream in in-vivo studies. Skin blanching assay using a chromameter showed vasoconstriction similar to that of the commercial product. There were no barrier function changes upon application of nanoparticles. In-vitro and in-vivo results demonstrated that lecithin/chitosan nanoparticles in chitosan gel may be a promising carrier for dermal delivery of DFV in various skin disorders.

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Section: Skin Blanching Assaymentioning

confidence: 99%

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Özcan¹,

Azizoğlu²,

Şenyiğit³

et al. 2013

IJN

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“…The 2007 critical path report (4) (32,33,34,35) or tape stripping (36,37,38,39,40,41,42,43,44,45) for dermatological products) could be used as a bioequivalence method when blood concentrations are not appropriate.…”

Section: New Methods For Locally Acting Drugsmentioning

confidence: 99%

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

Lionberger

2008

AAPS J

100

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Abstract. FDA's critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document "Critical Path Opportunities for Generic Drugs" that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs.

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“…After stripping a specified skin area, the penetrant is extracted from the tape and subsequently analysed with traditional analytical methods. The sampling method has some manual steps, which requires trained personnel to avoid significant interpersonal and interlaboratory variability [23].…”

Section: Tape Strippingmentioning

confidence: 99%

Percutaneous Penetration ‐ Methodological Considerations

Holmgaard

Benfeldt

Nielsen

2014

Basic Clin Pharma Tox

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Studies on percutaneous penetration are needed to assess the hazards after unintended occupational skin exposures to industrial products as well as the efficacy after intended consumer exposure to topically applied medicinal or cosmetic products. During recent decades, a number of methods have been developed to replace methods involving experimental animals. The results obtained from these methods are decided not only by the chemical or product tested, but to a significant degree also by the experimental set-up and decisions made by the investigator during the planning phase. The present MiniReview discusses some of the existing and well-known experimental in vitro and in vivo methods for studies of percutaneous penetration together with some more recent and promising methods. After this, some considerations and recommendations about advantages and limitations of the different methods and their relevance for the prediction of percutaneous penetration are given. Which method to prefer will depend on the product to be tested and the question asked. Regulatory guidelines exist for studies on percutaneous penetration, but researchers as well as regulatory bodies need to pay specific attention to the vehicles and solvents used in donor and sampling fluids so that it reflects in-use conditions as closely as possible. Based on available experimental data, mathematical models have been developed to aid predictions of skin penetration. The authors question the general use of the present mathematical models in hazard assessment, as they seem to ignore outliers among chemicals as well as the heterogeneity of skin barrier properties and skin conditions within the exposed populations. This MiniReview will discuss some of the existing and wellknown experimental in vitro and in vivo models together with some more recent and promising models and give some considerations and recommendations about advantages and limitations of the various models and their relevance for predictions of percutaneous penetration. An overview of the methodologies discussed can be found in table 1.Dermal exposure may be unintentional after environmental or occupational exposure or intentional after the use of topically applied medication or use of cosmetic products. In all cases, the assessment of the potential for percutaneous penetration or temporary deposition within the skin is an essential element in assessing risk as well as efficacy after dermal exposures.Decades of preventive efforts have decreased the inhalational exposures at work places. At the same time, topically applied pharmaceuticals are being used ever more often. Together, this has increased the relative importance of dermal exposures.Knowledge concerning percutaneous penetration and the potential to reach target sites closes the gap from exposure assessment and hazard identification to risk assessment. If a substance is unable to penetrate the stratum corneum (SC) or affect the skin barrier function in any way, then the need for further assessment of risk becomes less evide...

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Comparison of Skin Stripping, in vitro Release, and Skin Blanching Response Methods to Measure Dose Response and Similarity of Triamcinolone Acetonide Cream Strengths from Two Manufactured Sources

Cited by 44 publications

References 14 publications

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

Enhanced dermal delivery of diflucortolone valerate using lecithin/chitosan nanoparticles: in-vitro and in-vivo evaluations

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

Percutaneous Penetration ‐ Methodological Considerations

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