A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells

Pantelić, Ivana; Ilić, Tanja; Marković, Bojan; Savić, Sanela; Lukić, Milica

doi:10.2298/hemind170726019p

Cited by 6 publications

(4 citation statements)

References 24 publications

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“…Extraction was performed using methanol (HPLC grade) and samples were left to shake for 24 h. Then, samples were put in ultrasound bath for 15 min at room temperature and were centrifuged until the transparence of the supernatant was observed (3000 rpm, 15–30 min, 25 °C). Supernatant was stored at 4 °C until analysis and skin was discarded [ 39 ].…”

Section: Methodsmentioning

confidence: 99%

Biological Evaluation of Oil-in-Water Microemulsions as Carriers of Benzothiophene Analogues for Dermal Applications

et al. 2021

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During the last decade, many studies have been reported on the design and formulation of novel drug delivery systems proposed for dermal or transdermal administration. The efforts focus on the development of biocompatible nanodispersions that can be delivered to the skin and treat severe skin disorders, including cancer. In this context, oil-in-water (O/W) microemulsions have been developed to encapsulate and deliver lipophilic bioactive molecules for dermal application. An O/W biocompatible microemulsion composed of PBS buffer, Tween 80, and triacetin was assessed for its efficacy as a drug carrier of DPS-2, a lead compound, initially designed in-house to inhibit BRAFV600E oncogenic kinase. The system was evaluated through both in vitro and ex vivo approaches. The cytotoxic effect, in the presence and absence of DPS-2, was examined through the thiazolyl blue tetrazolium bromide (MTT) cell proliferation assay using various cell lines. Further investigation through Western blotting revealed that cells died of necrosis. Porcine ear skin was used as a skin model to evaluate the degree of permeation of DPS-2 through skin and assess its retention. Through the ex vivo experiments, it was clarified that encapsulated DPS-2 was distributed within the full thickness of the stratum corneum (SC) and had a high affinity to hair follicles.

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Section: Methodsmentioning

confidence: 99%

Biological Evaluation of Oil-in-Water Microemulsions as Carriers of Benzothiophene Analogues for Dermal Applications

et al. 2021

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“…Takođe, pozivamo autore i da podnesu stručne radove koji će opisati njihove originalne eksperimentalne procedure kao što je to u dva odlična rada: Pantelić i sar. [14], A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells, Hem. Ind.…”

Section: Bojana Obradovićunclassified

“…We carefully inspect the Materials and Methods section where the authors are required to state the producers and grades of all materials as well as equipment used, number of replicates, statistical analysis of the results and detailed experimental protocols so that they could be replicated by an independent expert in the field. We also encourage authors to submit technical contributions describing their experimental protocols and technical solutions such as excellent manuscripts Pantelić et al [14]., A stepwise protocol for drug permeation assessment that combines heatseparated porcine ear epidermis and vertical diffusion cells, Hem. Ind.…”

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confidence: 99%

Connecting science and industry with improved communication of research results

Obradović¹

2019

Hem Ind

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Research for innovation" has been Serbian national scientific and technological development strategy for 2016-2020 period [1]. Similar strategies have been adopted elsewhere, including in the European Union. Horizon 2020, the EU Research and Innovation programme, implementing the Europe 2020 flagship initiative "Innovation Union", which indicates that efficient research utilization and innovation are the means for smart, sustainable and inclusive growth of the society. 'Innovation' is defined as the actual implementation of new ideas, inventions or technologies to create a new value, not only for an individual or organization but also for the society as a whole, with ultimate aim of creating a smart future [2]. One of the goals in the Serbian national strategy is to assure relevance of the scientific research in Serbia for the industrial needs. Currently, the scientific research in Serbia, like in some other, especially developing countries [3], is majorly oriented towards production of scientific publications. Patent applications and novel technical solutions yielded only 3.3 % of the total scientific output in the preceding period 2011-2015 in Serbia [1]. However, the process of implementing the research findings into practice is burdened with substantial challenges, which include effective communication of the new knowledge to target stakeholders and actual implementation by the users [4]. Academic writing has often been regarded as being unnecessarily complex. And although practitioners in the field of technical and professional communication found that much of the published scientific research is indeed related to their practice, they found the research was not communicated in the way that could easily be adopted to their work [5]. This finding could probably be extended to other scientific fields as well. Exacerbating problem is the so called "publish or perish" culture, still persisting in many academic environments. The number of scientific publications remains to be a measure for researchers' performance and a requirement for career advancement. Such metric promotes literature quantity over research quality and sometimes leads to publication of low-quality research with incorrect conclusions [6]. It was reported that over 50 % of published results in preclinical life-sciences research cannot be reproduced independently under specified experimental conditions [7]. This is partially attributed to the desire of academic researchers to publish novel findings as quickly as possible without rigorous examination and replication and to show only positive results in order to reach high-impact factor journals [7,8]. The 'publish or perish' culture could also lead to increase in incidences of plagiarism and fabricated results [9]. Furthermore, the use of bibliometrics as a sole measure of scientific performance influences both scientists, especially early in academic careers, and main research trends. A study on doctoral students and postdoctoral scientists has shown that those pursuing academic career feel forced ...

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“…Stratum corneum is usually prepared by immersing full-thickness skin in hot water for brief seconds. This technique is also known as heat-separated epidermis (HSE) [ 4 , 6 , 7 , 8 , 9 ]. Other approaches to isolate skin layers include chemical or enzymatic separation, but those are rarely used techniques.…”

Section: Introductionmentioning

confidence: 99%

Reconstructed Human Epidermis: An Alternative Approach for In Vitro Bioequivalence Testing of Topical Products

Agonia

Palmeira‐de‐Oliveira

Cardoso³

et al. 2022

Pharmaceutics

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The use of in vitro human skin permeation tests is of value when addressing the quality and equivalence of topical drug products in Europe and the US. Human skin is the membrane of choice for these studies. The use of human skin as a membrane is hindered by limited access, high variability of results, and limited applicability for drugs with low skin permeability. Reconstructed human epidermis (RhE) models are validated as skin surrogates for safety tests and have been explored for percutaneous absorption testing. Clotrimazole poorly permeates human skin and is widely available for topical treatments. In this study, clotrimazole creams were used to test the ability of RhE to be used as biological membrane for bioequivalence testing, based on the Draft Guideline on Quality and Equivalence of Topical Products (CHMP/QWP/708282/2018) using a discriminative and modified in vitro permeation test (IVPT). To fulfill the validation of a discriminatory method, Canesten® 10 mg/g cream was compared with a test product with the same drug strength, along with two “negative controls” dosed at a 50% and 200% drug strength. Products were compared in finite dose conditions, regarding maximal flux (Jmax) and the total amount of drug permeated (Atotal). The results showed the discriminatory power of the method among the three drug strengths with no interference of the placebo formulation. The study design and validation complied with the requirements established in the guideline for a valid IVPT. This new test system allowed for the equivalence comparison between test and comparator product. Higher permeability of the RhE compared to human skin could be observed. This arose as a strength of the model for this modified IVPT bioequivalence testing, since comparing permeation profiles among products is envisaged instead of drawing absolute conclusions on skin permeation extent. These results may support the acceptance of RhE as biological membranes for modified IVPT in bioequivalence testing of topical products.

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A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells

Cited by 6 publications

References 24 publications

Biological Evaluation of Oil-in-Water Microemulsions as Carriers of Benzothiophene Analogues for Dermal Applications

Biological Evaluation of Oil-in-Water Microemulsions as Carriers of Benzothiophene Analogues for Dermal Applications

Connecting science and industry with improved communication of research results

Reconstructed Human Epidermis: An Alternative Approach for In Vitro Bioequivalence Testing of Topical Products

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