In‐Vitro Release from Corticosteroid Ointments

Shah, Vinod P.; Elkins, Jerome

doi:10.1002/jps.2600840920

Cited by 28 publications

(15 citation statements)

References 3 publications

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“…(Fiala et al, 2008). It has been used extensively to measure drug release rates from topical formulations (Guy and Hadgraft, 1990;Shah and Elkins, 1995). Previous work had shown that lidocaine and prilocaine were not retained by regenerated cellulose membrane (Fiala et al, 2008), therefore drug release from the formulation in the absence of partitioning was measured.…”

Section: Drug Releasementioning

confidence: 99%

A fundamental investigation into the effects of eutectic formation on transmembrane transport

Fiala¹,

Jones²,

Brown³

2010

International Journal of Pharmaceutics

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Section: Drug Releasementioning

confidence: 99%

A fundamental investigation into the effects of eutectic formation on transmembrane transport

Fiala¹,

Jones²,

Brown³

2010

International Journal of Pharmaceutics

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“…De pending on the solubility of the drug substance,t h e re ce p tor medium may need to co ntain alcohol and/or s u rf a ct a nt .De -a e ration is cri t i cal to avoid bubble fo rm at i o n at the inte rf a ce with the membra n e.A synthetic membra n e is often used to serve as an inert suppo rt membra n e. De pending on the chara cte ristics of the drug prod u ct,i t m ay also be possible to co n d u ct the in vitro test without a s y nthetic suppo rt membrane (8).For some oint m e nt s,t h e Franz cell has been used with and without membra n e s, resulting in no diffe re n ces in release rate re s u l t s.The dru g release chara cte ristics usually fo l l ow the Higuchi model (9). As with tra n s d e rmal prod u ct s,the test te m pe rat u re is ty p ically set at 32°C to re f l e ct the usual skin te m pe rat u re.Dev i ations might be justified in case of prod u cts for specific site s of act i o n ,e. g.vaginal creams may be te s ted at 37°C.…”

Section: Semi-solid To P I Cal Dosage Fo Rm Smentioning

confidence: 99%

FIP/AAPS Guidelines for Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms*

Siewert¹,

Dressman²,

Brown³

et al. 2003

Dissolution Technol.

102

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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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In‐Vitro Release from Corticosteroid Ointments

Cited by 28 publications

References 3 publications

A fundamental investigation into the effects of eutectic formation on transmembrane transport

A fundamental investigation into the effects of eutectic formation on transmembrane transport

FIP/AAPS Guidelines for Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms*

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

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