Strat-M® synthetic membrane: Permeability comparison to human cadaver skin

Haq, Anika; Goodyear, Benjamin; Ameen, Dina; Joshi, Vivek; Michniak‐Kohn, Bozena

doi:10.1016/j.ijpharm.2018.06.012

Cited by 148 publications

(103 citation statements)

References 30 publications

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“…A good correlation coefficient for the permeation of chemicals was found between the artificial membrane with rat and human skin [6]. Recently, a study on the permeation of nicotine from formulations with binary solvents (water and chemical penetration enhancers) applied as a large finite dose (200 µL/0.64 cm 2 ) reported similar findings, where a good correlation between the artificial membrane and human skin was found [4]. Other advantages associated with the Strat-M ® membrane are its simplicity of handling, low-cost, and low variability of lot-to-lot quality as opposed to animal-based models.…”

Section: Introductionmentioning

confidence: 56%

“…It was engineered to mimic key structural and chemical features of human skin. This multi-layer artificial membrane possesses a tight top layer coated with a lipid blend resembling the lipid chemistry of the human stratum corneum (SC) and a porous lower layer resembling the epidermis and dermis layers [4]. This membrane possesses equivalency to human skin for the skin permeation of many drugs and claims to have better correlations compared with other biological membranes [5].…”

Section: Introductionmentioning

confidence: 99%

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Usefulness of Artificial Membrane, Strat-M®, in the Assessment of Drug Permeation from Complex Vehicles in Finite Dose Conditions

et al. 2020

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The ban on the use of animals in testing cosmetic products has led to the development of animal-free in vitro methods. Strat-M® is an artificial membrane engineered to mimic human skin and is recommended as a replacement for skin. However, its usefulness in the assessment of the permeation of cosmetics in in-use conditions remains unverified. No data have been published on its comparative performance with the membrane of choice, porcine skin. The comparative permeability characteristics of Strat-M® and porcine skin were investigated using Franz diffusion cells. Caffeine (CF) and rhododendrol (RD) in complex vehicles with varying concentrations of polyols were applied as finite and infinite doses. Good rank orders of permeation from finite dose experiments were observed for RD. High correlations were observed in RD permeation between Strat-M® and porcine skin under finite and infinite dose conditions, whereas only finite dose conditions for CF were associated with good correlations. Permeation from formulations with high polyol content and residual formulations was enhanced due to the disruption of the integrity of the Strat-M® barrier. The usefulness of Strat-M® in the assessment of dermal permeation may be limited to finite dose conditions and not applicable to infinite dose conditions or formulations applied in layers.

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Section: Introductionmentioning

confidence: 56%

Section: Introductionmentioning

confidence: 99%

Usefulness of Artificial Membrane, Strat-M®, in the Assessment of Drug Permeation from Complex Vehicles in Finite Dose Conditions

et al. 2020

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“…Recently, Haq et al compared the Strat-M ® membrane with human skin on permeation of nicotine. Results showed that there was again a high correlation between human skin and Strat-M ® with R 2 value of 0.99 [40]. Hence, we used Strat-M ® as a diffusion membrane for our studies.…”

Section: In-vitro Permeation Studiesmentioning

confidence: 90%

Evaluation of Formulation Parameters on Permeation of Ibuprofen from Topical Formulations Using Strat-M® Membrane

et al. 2020

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Topical drug delivery is an attractive alternative to conventional methods because of advantages such as non-invasive delivery, by-pass of first pass metabolism, and improved patient compliance. However, several factors such as skin, physicochemical properties of the drug, and vehicle characteristics influence the permeation. Within a formulation, critical factors such as concentration of drug, physical state of drug in the formulation, and organoleptic properties affect the flux across the skin. The aim of the study was to develop and investigate topical semisolid preparations (creams and gels) with ibuprofen as the model drug and investigate the effect of various formulation parameters on the in-vitro performance across the Strat-M® membrane using flow-through cells. In addition, the physical stability of the developed formulations was investigated by studying viscosity, pH, and appearance. All the formulations developed in the study had appealing appearance with smooth texture and no signs of separation. Viscosity and pH of the formulations were acceptable. Cumulative amount of drug permeated at the end of 24 h was highest for clear gel (3% w/w ibuprofen; F6: 739.6 ± 36.1 µg/cm2) followed by cream with high concentration of ibuprofen in suspended form (5% w/w; F3: 320.8 ± 17.53 µg/cm2), emulgel (3% w/w ibuprofen; F5: 178.5 ± 34.5 µg/cm2), and cream with solubilized ibuprofen (3% w/w; F2A: 163.2 ± 9.36 µg/cm2). Results from this study showed that permeation of ibuprofen was significantly influenced by formulation parameters such as concentration of ibuprofen (3% vs. 5% w/w), physical state of ibuprofen (solubilized vs. suspended), formulation type (cream vs. gel), mucoadhesive agents, and viscosity (high vs. low). Thus, findings from this study indicate that pharmaceutical formulation scientists should explore these critical factors during the early development of any new topical drug product in order to meet pre-determined quality target product profile.

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“…However, dissimilarities exist in the level of vascularization, fat component of the SC organized in hexagonal lattice in pigs and orthorhombic lattice in human (Praça et al, 2018). The goal is the permeation of active ingredients in stratum corneum, which is popularly referred to as the rate limiting barrier before successfully permeating through the epidermis (Haq et al, 2018).…”

Section: Ex Vivo Skin Permeationmentioning

confidence: 99%

Mushroom ethanolic extracts as cosmeceuticals ingredients: Safety and ex vivo skin permeation studies

Taofiq

Rodrigues

Barros

et al. 2019

Food and Chemical Toxicology

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Mushrooms are important sources of natural bioactive compounds that are increasingly used as cosmeceutical ingredients. In this context, ethanolic extracts were prepared from Ganoderma lucidum and Pleurotus ostreatus and tested by incorporation into base cosmetic creams. In vitro safety evaluation of the extracts and cosmetic formulations prepared therefore was carried out using the MTT and LDH assays in keratinocyte (HaCaT) and fibroblast (HFF-1) cell lines. Moreover, they were submitted to ex vivo skin permeation studies using a Franz diffusion apparatus with pig ear skin as permeation membrane. The results showed the absence of toxicity for keratinocytes and fibroblasts in a concentration dependent manner, which is indicative of the safety of these extracts for cosmeceutical ingredients purposes. Protocatechuic and syringic acids were the only compounds permeating from G. lucidum extract in the first 8 h of study, no penetration was observed for phenolic acids found in P. ostreatus extract and formulation. These results pointed out for the suitability of using mushroom extracts as skin care ingredients and may contribute for the valorisation of wastes generated by the mushroom processing industry, which can serve as raw-materials for the obtainment of the extracts.

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Strat-M® synthetic membrane: Permeability comparison to human cadaver skin

Cited by 148 publications

References 30 publications

Usefulness of Artificial Membrane, Strat-M®, in the Assessment of Drug Permeation from Complex Vehicles in Finite Dose Conditions

Usefulness of Artificial Membrane, Strat-M®, in the Assessment of Drug Permeation from Complex Vehicles in Finite Dose Conditions

Evaluation of Formulation Parameters on Permeation of Ibuprofen from Topical Formulations Using Strat-M® Membrane

Mushroom ethanolic extracts as cosmeceuticals ingredients: Safety and ex vivo skin permeation studies

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