Determination of in vitro drug release from hydrocortisone creams

Shah, Vinod P.; Elkins, Jerome; Lam, See-Yan; Skelly, Jerome P.

doi:10.1016/0378-5173(89)90361-x

Cited by 101 publications

(49 citation statements)

References 6 publications

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“…Within this context, the use of in vitro static diffusion cells to assess skin permeability has evolved into a major research methodology, providing key insights into the relationships between skin, drug and formulation (1,2). Such testing is highly useful not only for the design and development of novel formulations but also for toxicity screening and quality-control purposes (3)(4)(5)(6).…”

Section: Introductionmentioning

confidence: 99%

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

et al. 2010

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Abstract. Over the years, in vitro Franz diffusion experiments have evolved into one of the most important methods for researching transdermal drug administration. Unfortunately, this type of testing often yields permeation data that suffer from poor reproducibility. Moreover, this feature frequently occurs when synthetic membranes are used as barriers, in which case biological tissue-associated variability has been removed as an artefact of total variation. The objective of the current study was to evaluate the influence of a full-validation protocol on the performance of a tailor-made array of Franz diffusion cells (GlaxoSmithKline, Harlow, UK) available in our laboratory. To this end, ibuprofen was used as a model hydrophobic drug while synthetic membranes were used as barriers. The parameters investigated included Franz cell dimensions, stirring conditions, membrane type, membrane treatment, temperature regulation and sampling frequency. It was determined that validation dramatically reduced derived data variability as the coefficient of variation for steady-state ibuprofen permeation from a gel formulation was reduced from 25.7% to 5.3% (n=6). Thus, validation and refinement of the protocol combined with improved operator training can greatly enhance reproducibility in Franz cell experimentation.

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Section: Introductionmentioning

confidence: 99%

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

et al. 2010

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“…According to published data (Shah et al, 1989;Shah, Elkins, 1995;Shah, Elkins, Williamns et al, 1999;Ng et al, 2010) there is no standard for the membrane, which should thus be tested for each drug, vehicle and receptor medium. The most common membranes employed in in vitro release test are silicone, cellulose and polysulfone membranes (Ng et al, 2010).…”

Section: Comparison Of the Results Obtained With Polyethersulfone Andmentioning

confidence: 99%

In vitro release of diclofenac diethylamine from gels: evaluation of generic semisolid drug products in Brazil

Goebel

Sato

Souza

et al. 2013

Braz. J. Pharm. Sci.

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In order for the pharmacological action of a topical dermal drug product to occur, the drug must first be released from the vehicle to be available to penetrate the skin layers and reach the site of action. Drug release is mainly dependent on the characteristics of the formulation. Currently, to register a generic or a similar drug product in Brazil performance testing of topical drug products for local action is not required. In this context, this aim of this study was to evaluate the in vitro release of commercial diclofenac diethylamine gel products available on the Brazilian pharmaceutical market, using the vertical diffusion cell method. Factors which may influence the test, such as the type of membrane used, and the effect of the formulation characteristics on the diffusion rate were evaluated. Brazilian legislation currently allows generic drug products to contain excipients other than the reference drug, which may affect the drug release from the vehicle. Only one of the four generic drug products tested could be considered equivalent to the reference Cataflam Emulgel ® . The cellulose acetate and polyethersulfone membranes tested were found to be interchangeable in the in vitro release studies carried out on this product. Uniterms:In vitro release test. Diclofenac diethylamine/gel. Synthetic membranes. Generic semisolid drug products.Para exercer ação farmacológica, medicamentos tópicos de aplicação cutânea precisam, primeiramente, liberar o fármaco do veículo, para que desta forma ele se torne disponível para penetração nas camadas da pele, até atingir seu local de ação. A liberação do fármaco do veículo depende principalmente das características da formulação. Até a presente data, para registrar um medicamento genérico ou similar no Brasil não se exigem testes de desempenho para produtos tópicos de ação local. O presente trabalho teve como objetivo avaliar a liberação in vitro de especialidades farmacêuticas de diclofenaco dietilamônio gel do mercado farmacêutico brasileiro, usando o sistema de célula de difusão vertical. Avaliaram-se fatores que influenciam o teste como o tipo de membrana usada nos ensaios de liberação e características da formulação que impactam a velocidade de difusão. A legislação vigente no País permite que medicamentos genéricos contenham excipientes diferentes do medicamento referência. Esta diferença afetou a liberação do fármaco do veículo. Dos quatro medicamentos genéricos testados apenas um seria considerado equivalente ao medicamento referência Cataflam Emulgel ® . As membranas de acetato de celulose e polietersulfona testadas apresentaram-se intercambiáveis nos estudos de liberação desse produto.

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“…During the course of the study, 0.5 mL of sample was collected from the receiver compartment at various time points and was subsequently replaced with fresh buffer. The collected samples were suitably diluted and analyzed using an HPLC-UV system (Waters Corp) (17)(18)(19)(20)(21)(22)(23).…”

Section: In Vitro Release Testingmentioning

confidence: 99%

Development of an Ointment Formulation Using Hot-Melt Extrusion Technology

et al. 2015

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Abstract. Ointments are generally prepared either by fusion or by levigation methods. The current study proposes the use of hot-melt extrusion (HME) processing for the preparation of a polyethylene glycol base ointment. Lidocaine was used as a model drug. A modified screw design was used in this process, and parameters such as feeding rate, barrel temperature, and screw speed were optimized to obtain a uniform product. The product characteristics were compared with an ointment of similar composition prepared by conventional fusion method. The rheological properties, drug release profile, and texture characteristics of the hot-melt extruded product were similar to the conventionally prepared product. This study demonstrates a novel application of the hotmelt extrusion process in the manufacturing of topical semi-solids.

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Determination of in vitro drug release from hydrocortisone creams

Cited by 101 publications

References 6 publications

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

In vitro release of diclofenac diethylamine from gels: evaluation of generic semisolid drug products in Brazil

Development of an Ointment Formulation Using Hot-Melt Extrusion Technology

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