Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

Kanfer, Isadore

doi:10.4172/jbb.1000040

Cited by 15 publications

(13 citation statements)

References 48 publications

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“…This method is restricted to the bioequivalence assessment of topical corticosteroid formulations (Larsson, 1991). Vasoconstrictor assay method follows the FDA guidance for topical dermatological glucocorticoids -in vivo bioequivalence (Kanfer, 2010). A hill top chamber (~1.2 cm) is affixed to the skin surface with adhesive tape and specified volume of formulation or sample was applied in the chamber.…”

Section: Vasoconstrictor Assaymentioning

confidence: 99%

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Basic considerations in the dermatokinetics of topical formulations

Nair

Jacob

Al‐Dhubiab

et al. 2013

Braz. J. Pharm. Sci.

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Assessing the bioavailability of drug molecules at the site of action provides better insight into the efficiency of a dosage form. However, determining drug concentration in the skin layers following topical application of dermatological formulations is a great challenge. The protocols followed in oral formulations could not be applied for topical dosage forms. The regulatory agencies are considering several possible approaches such as tape stripping, microdialysis etc. On the other hand, the skin bioavailability assessment of xenobiotics is equally important for topical formulations in order to evaluate the toxicity. It is always possible that drug molecules applied on the skin surface may transport thorough the skin and reaches systemic circulation. Thus the real time measurement of molecules in the skin layer has become obligatory. In the last two decades, quite a few investigations have been carried out to assess the skin bioavailability and toxicity of topical/dermatological products. This review provides current understanding on the basics of dermatokinetics, drug depot formation, skin metabolism and clearance of drug molecules from the skin layers following application of topical formulations.Uniterms: Dermatological formulations/pharmacokinetics. Dermatological formulations/ toxicity. Dermatokinetics. Skin/metabolism. Microdialysis. Tape stripping.A avaliação da biodisponibilidade de moléculas de fármacos no sítio de ação oferece melhor compreensão sobre a eficiência da forma de dosagem. Entretanto, a determinação da concentração de fármaco nas camadas da pele em seguida à aplicação tópica de formulações dermatológicas é um grande desafio. Os protocolos seguidos para as formulações orais não podem ser aplicados para as formulações tópicas. As agências regulatórias consideram várias abordagens possíveis, tape stripping, microdiálise etc. Por outro lado, a avaliação da biodisponibilidade de xenobióticos na pele é igualmente importante para as formulações tópicas para se avaliar a toxicidade. É sempre possível que as moléculas de fármaco aplicadas na superfície da pele sejam transportadas através da pele e alcancem a circulação sistêmica. Assim, a medida em tempo real de moléculas na camada da pele tem se tornado obrigatória. Nas últimas duas décadas, realizaram-se poucas pesquisas para avaliar a biodisponibilidade da pele e a toxicidade de produtos tópicos/dermatológicos. Esta revisão fornece a compreensão atual com base na dermatocinética, formação de fármaco de depósito, metabolismo da pele e o clearance das moléculas de fármaco das camadas da pele em seguida à aplicação de formulações tópicas.Unitermos: Formulações dermatológicas/farmacocinética. Formulações dermatológicas/toxicidade. Dermatocinética Pele/metabolismo. Microdiálise. Tape stripping.

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Section: Vasoconstrictor Assaymentioning

confidence: 99%

“…The blanching response can be assessed by one or more observers used are taken into consideration for data processing. The total possible score expressed in percentage and is determined as (Kanfer, 2010);…”

Section: Vasoconstrictor Assaymentioning

confidence: 99%

Basic considerations in the dermatokinetics of topical formulations

Nair

Jacob

Al‐Dhubiab

et al. 2013

Braz. J. Pharm. Sci.

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“…Post compression parameters: All the prepared tablets were subjected to various physical characteristics like Crushing strength, Friability, Thickness, Diameter, Hole depth, Disintegration time, Wetting time, Weight variation, Drug content [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35].…”

Section: Evaluation Of Tabletsmentioning

confidence: 99%

Role of Novel Hole Technology in Fast Dissolving Tablets

Damodar¹,

Cv²

2014

J Mol Pharm Org Process Res

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This review is concerning Fast dissolving tablets ready by Novel Hole technology. Once these Fast dissolving tablets contact with gastric fluids, the fluid can enters the hole formed within the tablet and immediate breaking of the tablet goes to takes place. This quick disintegration of tablets is additionally influenced by the formation of latest absolute space. This method is novel and most helpful for formulation into Fast dissolving tablets.

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“…All the ingredients (Metformin Hcl, Avicel pH 101, Cross povidone, Aerosil in required quantities) as shown in Table 2 were mixed, and then various percentages of sustained release beads and 2% magnesium stearate, talc were added and compressed into tablets [21][22][23][24][25][26][27]. All the dosage forms were compressed at similar conditions but the final dosage form was selected based on drug release profiles.…”

Section: Preparation Of Tablets Containing Sr Micro Beadsmentioning

confidence: 99%

Preparation and In-vitro Evaluation of Metformin HCl Tablets Containing Sustained Release Beads for Increasing Therapeutic Window

Damodar¹

2014

Bioequiv Availab

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Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

Cited by 15 publications

References 48 publications

Basic considerations in the dermatokinetics of topical formulations

Basic considerations in the dermatokinetics of topical formulations

Role of Novel Hole Technology in Fast Dissolving Tablets

Preparation and In-vitro Evaluation of Metformin HCl Tablets Containing Sustained Release Beads for Increasing Therapeutic Window

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