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Flynn, Gordon L.; Shah, Vinod P.; Tenjarla, Srinivas N.; Corbo, Michael; DeMagistris, David; Feldman, T.; Franz, Thomas; Miran, Deborah R.; Pearce, D. M.; Sequeira, Joel; Swarbrick, James; Wang, Jonas C. T.; Yacobi, Avi; Zatz, Joel L.

doi:10.1023/a:1018997520950

Cited by 70 publications

(10 citation statements)

References 25 publications

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“…The DEX flux was calculated from the slope of the linear portion of the curve by plotting the amount of DEX released per cm 2 against the square root of time [38,39]. Results are presented in Figure 9.…”

Section: Resultsmentioning

confidence: 99%

Submicron polymeric particles prepared by vibrational spray-drying: Semisolid formulation and skin penetration/permeation studies

Beber¹,

Andrade²,

Kann³

et al. 2014

European Journal of Pharmaceutics and Biopharmaceutics

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Topical glucocorticoids (TG) such as dexamethasone (DEX) have been used for decades for the treatment of skin diseases. However, TG present welldocumented side effects and their delivery to the skin is often insufficient.Therefore, many efforts have been undergone to improve the amount of drug delivered to the skin and to reduce side effects at the same time. In this work, the feasibility of DEX-submicron polymeric particles (SP) prepared by vibrational spray-drying as an approach to overcome the challenges associated with the topical administration of this drug class was evaluated. DEX was homogeneously dispersed in the SP matrix, according to confocal Raman microscopy analysis. Drug-loaded SP were incorporated into the oil phase of oil-in-water emulsions (creams). The formulation containing polymeric submicron particles (C-SP) showed controlled drug release kinetics and a significant drug accumulation in skin compared to formulations containing nonpolymeric particles or free drug. DEX accumulation in the stratum corneum was evaluated by tape stripping and a depot effect over time was observed for C-SP, while the formulation containing the free drug showed a decrease over time.Similarly, C-SP presented higher drug retention in epidermis and dermis in skin penetration studies performed on pig skin in Franz diffusion cells, while drug permeation into the receptor compartment was negligible. It was demonstrated, for the first time, the advantageous application of submicron polymeric particles obtained by vibrational spray-drying in semisolid formulations for cutaneous administration to overcome challenges related to the therapy with TG such as DEX.

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Section: Resultsmentioning

confidence: 99%

Submicron polymeric particles prepared by vibrational spray-drying: Semisolid formulation and skin penetration/permeation studies

Beber¹,

Andrade²,

Kann³

et al. 2014

European Journal of Pharmaceutics and Biopharmaceutics

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“…Although in vitro diffusion cell testing generally cannot be used to predict bioavailability in vivo , it is a useful technique for the characterization of drug delivery systems and for product quality control in manufacturing 24,25 . In the present in vitro drug delivery testing, as predicted from diffusion theory in the model simulations, the diffusion coefficients of the drug in the formulations and the diffusion areas for drug release can significantly affect drug release from the formulations, and hence resulting in the different drug release profiles observed among the different formulations and between the conventional and modified diffusion cells.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of intratympanic formulations for inner ear delivery: methodology and sustained release formulation testing

Liu

Feng

Tolia

et al. 2013

Drug Development and Industrial Pharmacy

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A convenient and efficient in vitro diffusion cell method to evaluate formulations for inner ear delivery via the intratympanic route is currently not available. The existing in vitro diffusion cell systems commonly used to evaluate drug formulations do not resemble the physical dimensions of the middle ear and round window membrane. The objectives of this study were to examine a modified in vitro diffusion cell system of a small diffusion area for studying sustained release formulations in inner ear drug delivery and to identify a formulation for sustained drug delivery to the inner ear. Four formulations and a control were examined in this study using cidofovir as the model drug. Drug release from the formulations in the modified diffusion cell system was slower than that in the conventional diffusion cell system due to the decrease in the diffusion surface area of the modified diffusion cell system. The modified diffusion cell system was able to show different drug release behaviors among the formulations and allowed formulation evaluation better than the conventional diffusion cell system. Among the formulations investigated, poly(lactic-co-glycolic acid)–poly(ethylene glycol)–poly(lactic-co-glycolic acid) triblock copolymer systems provided the longest sustained drug delivery, probably due to their rigid gel structures and/or polymer-to-cidofovir interactions.

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“…Various dimensions are described with orifice diameter, receptor volume, and donor chamber size being the most critical to understand to keep variability as low as possible. During the last 20 years, various publications have reviewed various aspects and applications of IVRT as a tool to support topical product development, from scale-up and post-approval changes for non-sterile semisolid dosage forms (SUPAC-SS) to the more recently proposed topical drug classification system (TCS) (5)(6)(7)(8)(9).…”

mentioning

confidence: 99%

In Vitro Release Testing Methodology and Variability with the Vertical Diffusion Cell (VDC)

Klein¹,

Heckart²,

Thakker³

2018

Dissolution Technol.

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In vitro release test (IVRT) using the vertical diffusion cell (VDC) is a well-established method to evaluate the performance of a topical dosage form and to better understand the physicochemical characteristics of the product. The VDC is the most frequently used apparatus to measure drug release from semisolid products and has been in use for more than fifty years; however, the technique is often hampered by high variability and inadequate reproducibility. Various method parameters influence drug release and the associated variation of the release profiles. The purpose of this manuscript is to examine the critical parameters of the VDC apparatus and the methods that are developed using it, and to highlight potential sources of variability that must be well understood to develop, validate, and implement highly effective VDC methods.

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Untitled

Cited by 70 publications

References 25 publications

Submicron polymeric particles prepared by vibrational spray-drying: Semisolid formulation and skin penetration/permeation studies

Submicron polymeric particles prepared by vibrational spray-drying: Semisolid formulation and skin penetration/permeation studies

Evaluation of intratympanic formulations for inner ear delivery: methodology and sustained release formulation testing

In Vitro Release Testing Methodology and Variability with the Vertical Diffusion Cell (VDC)

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