Evaluation of the Test System Used for In Vitro Release of Drugs for Topical Dermatological Drug Products

Shah, Vinod P.; Elkins, Jerome; Williams, Roger L.

doi:10.1081/pdt-100101373

Cited by 66 publications

(40 citation statements)

References 8 publications

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“…A high solubilization power of the receptor fluid could lead to enhanced flux from the donor compartment and may reduce the discriminating power of the method. Shah et al (11) have reported that the release rate for betamethasone dipropionate from creams ranged between 0.61 and 2.68 μg/cm 2 /min 1/2 depending on the percentage of ethanol in the receptor medium. The study indicates that the discriminating power of the method decreased as the ethanol content in the release medium was increased from 30% to 60%.…”

Section: Discussionmentioning

confidence: 99%

“…Alcoholic medium showed a positive effect on HC release (i.e., the higher the alcohol content in the medium, the faster the release rate due to the increased concentration gradient between the receptor and the donor compartment). Shah and coworkers (11,15) showed that 30% ethanolic medium was sufficient to maintain diffusional sink conditions while not adversely affecting the integrity of the dosage form.…”

Section: Discussionmentioning

confidence: 99%

“…This will ensure that a plateau in diffusion of drug is not reached prematurely as such a situation can show a poor diffusion for a good formulation. As a rule of thumb, the composition of receptor medium is chosen such that not more than 30% of the total amount of drug loaded is released into the receptor compartment at the end of study (11,12). Under such conditions, the amount of drug release per unit area is proportional to the square root of time exhibiting a Higuchi model release profile (10,12).…”

Section: Discussionmentioning

confidence: 99%

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Influence of Test Parameters on Release Rate of Hydrocortisone from Cream: Study Using Vertical Diffusion Cell

Naik¹,

Shah²,

Heaney³

et al. 2016

Dissolution Technol.

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Vertical diffusion cells (VDC) have been envisaged as in vitro surrogates for ensuring product quality and performance for topical preparations. USP General Chapter <1724> Semisolid Drug Products-Product Performance Tests describes the application of VDC as one of the apparatus required for in vitro testing of topical products. Knowledge of various operational parameters and their impact on drug release during diffusion experiments thus becomes imperative. In the present study, parameters like temperature, composition of receptor medium, speed of stirring, and filled volume of cell jacket have been evaluated for their influence on drug release rate from hydrocortisone cream employing vertical diffusion cells. The statistical analysis of the results was performed by one-way ANOVA with Bonferroni post hoc test. Results suggest that the composition of the receptor medium significantly influences drug release from cream, and slower stirring rates translate to lower release rates. On the other hand, within experimental design, the temperature of the receptor and filled condition of the cell jacket do not influence drug release significantly.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Influence of Test Parameters on Release Rate of Hydrocortisone from Cream: Study Using Vertical Diffusion Cell

Naik¹,

Shah²,

Heaney³

et al. 2016

Dissolution Technol.

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“…This diffusion study helps the scientists to understand the relationship between skin, drug, and formulation [3,4]. This further helps to optimize the formulation and process variables for optimizing the formulation as well as help to assess the toxicity of the drug [5][6][7][8]. The most common technique for measuring dermal absorption in vitro is the application of the test substance in an appropriate formulation to the surface of a skin sample, which is mounted as a barrier between the donor compartment and receptor compartment of a diffusion cell [9].…”

Section: Introductionmentioning

confidence: 99%

Design and Performance Verification of Newly Developed Disposable Static Diffusion Cell for Drug Diffusion/Permeability Studies

Yadav

Garg

Gulati

et al. 2018

Asian J Pharm Clin Res

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Objectives:The present study describes a disposable static diffusion cell for in vitro diffusion studies to achieve better results as compared to well existing Franz diffusion cell (FDC) in terms of the absence of bubbles, variable receptor compartment, ease of handling, and faster results. Materials and Methods:The cell consists of a cup-shaped donor compartment made of semi permeable that could be either cellophane membrane or, animal skin fitted to a rigid frame, which is supported on a plastic plate that contains a hole for the sample withdrawal. The receptor compartment is a separate unit, and it could be any container up to 500ml volume capacity. The most preferred receptor compartment is glass beaker. In the present study, goatskin was used as semi-permeable membrane and verification of its performance was carried out through diffusion studies using gel formulations of one each of the four-selected biopharmaceutical classification system (BCS) class drugs. Metronidazole, diclofenac sodium, fluconazole, and sulfadiazine were used as model drugs for BCS Class I, II, III, and IV, respectively. Results:The newly developed diffusion cell (NDDC) was found to provide faster and more reproducible results as compared to FDC. At the time interval of 24 h, the cell was found to exhibit a higher diffusion of metronidazole, diclofenac sodium, fluconazole, and sulfadiazine by 0.65, 0.65, 0.32, and 0.81 folds, respectively. The faster release obtained with NDDC was attributed to a larger surface area of skin as compared to that in FDC. Conclusion:It was concluded that better reproducibility of results could be achieved with NDDC.

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“…The vertical diffusion cell (VDC) apparatus, which uses a static diffusion cell, a synthetic membrane, and an appropriate receptor medium, has emerged as one of the most widely used apparatus for testing the in vitro release of topical dosage forms (2,3). The VDC apparatus is simple to operate and generally yields reliable and reproducible results when employed by properly trained laboratory personnel (4).…”

Section: Introductionmentioning

confidence: 99%

Effect of Various Operational Parameters on Drug Release from a 1% Hydrocortisone Semisolid Dosage Form Using the Vertical Diffusion Cell Apparatus

Kikwai¹,

Tran²,

Shah³

et al. 2012

Dissolution Technol.

Self Cite

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The purpose of this study was to identify operational parameters of the vertical diffusion cell (VDC) apparatus that have an influence on results of drug release testing from semisolid dosage forms, which are one of three types of topically applied products (see USP General Chapter Topical and Transdermal Drug Products-Product Quality Tests <3>). The VDC apparatus operates using a static diffusion cell, a synthetic membrane, and an appropriate receptor medium. A cream formulation containing 1% hydrocortisone was used for the current study. The operational parameters investigated were stirring rate, mixing helix, stirring while sampling, medium degassing, membrane wetting with Ethomeen (a surfactant), and membrane wetting time. Stat-Ease design of experiment software was used to create partial factorial experimental designs to evaluate these parameters. The effects of the operational parameters were evaluated using mean drug release rate (slope, µg/cm 2 /min ½ ) and the standard deviation (SD) of six individual release rates for each experimental setup.Results of the study indicate that one parameter, the presence of Ethomeen for wetting the membrane, had a large and significant effect on both drug release rates and SD. Two parameters, stirring while sampling and mixing helix, had a significant impact on the drug release rate when Ethomeen was not used. Two parameters, medium degassing and stirring while sampling, had significant effects on the variability of the results (SD).Additionally, instrument-specific parameters (e.g., mixing helix) also contributed significantly to the variability of drug release rates.

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Evaluation of the Test System Used for In Vitro Release of Drugs for Topical Dermatological Drug Products

Cited by 66 publications

References 8 publications

Influence of Test Parameters on Release Rate of Hydrocortisone from Cream: Study Using Vertical Diffusion Cell

Influence of Test Parameters on Release Rate of Hydrocortisone from Cream: Study Using Vertical Diffusion Cell

Design and Performance Verification of Newly Developed Disposable Static Diffusion Cell for Drug Diffusion/Permeability Studies

Effect of Various Operational Parameters on Drug Release from a 1% Hydrocortisone Semisolid Dosage Form Using the Vertical Diffusion Cell Apparatus

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