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A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells

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2018
3149.pdf (390.0Kb)
Authors
Pantelić, Ivana
Ilić, Tanja
Marković, Bojan
Savić, Sanela
Lukić, Milica
Savić, Snežana
Article (Published version)
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Abstract
After decades long absence of an official consensus on the most appropriate evaluation method for in vitro skin performance of topical semisolid drugs, United States Pharmacopoeia (USP 39) finally suggested three types of testing equipment; however, all these provide data on drug release using inert synthetic membranes. Considering the need for a readily available membrane that would be more structurally similar to human skin, this paper provides a detailed protocol of a method for drug permeation assessment that uses heat-separated porcine ear epidermis and modified Franz diffusion cells. Phases that were shown to be critical for variability of the results are identified (e.g., membrane preparation), and process parameters optimized. Applicability of the method was tested on four cream samples loaded with aceclofenac as a model drug. Sample compositions were designed in such a way to provide, large "variations (variation of the main stabilizer: natural-origin versus synthetic emulsifi...er) and relatively, minor" variations (co-solvent variation: none/isopropanol/glycerol). The developed protocol is a straightforward and reliable in vitro test for the evaluation of rate and extent of drug delivery into/through the skin. Moreover, this protocol may be routinely applied even in averagely equipped laboratories during formulation development or preliminary bioequivalence assessment of generic topical semisolids.

Keywords:
dermal drug delivery / rate and extent of drug permeation / hydrophilic creams / aceclofenac
Source:
Hemijska industrija, 2018, 72, 1, 47-53
Publisher:
  • Savez hemijskih inženjera, Beograd
Funding / projects:
  • Development of micro- and nanosystems as carriers for drugs with anti-inflammatory effect and methods for their characterization (RS-34031)

DOI: 10.2298/HEMIND170726019P

ISSN: 0367-598X

WoS: 000429312400006

Scopus: 2-s2.0-85043756818
[ Google Scholar ]
7
3
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3151
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Pantelić, Ivana
AU  - Ilić, Tanja
AU  - Marković, Bojan
AU  - Savić, Sanela
AU  - Lukić, Milica
AU  - Savić, Snežana
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3151
AB  - After decades long absence of an official consensus on the most appropriate evaluation method for in vitro skin performance of topical semisolid drugs, United States Pharmacopoeia (USP 39) finally suggested three types of testing equipment; however, all these provide data on drug release using inert synthetic membranes. Considering the need for a readily available membrane that would be more structurally similar to human skin, this paper provides a detailed protocol of a method for drug permeation assessment that uses heat-separated porcine ear epidermis and modified Franz diffusion cells. Phases that were shown to be critical for variability of the results are identified (e.g., membrane preparation), and process parameters optimized. Applicability of the method was tested on four cream samples loaded with aceclofenac as a model drug. Sample compositions were designed in such a way to provide, large "variations (variation of the main stabilizer: natural-origin versus synthetic emulsifier) and relatively, minor" variations (co-solvent variation: none/isopropanol/glycerol). The developed protocol is a straightforward and reliable in vitro test for the evaluation of rate and extent of drug delivery into/through the skin. Moreover, this protocol may be routinely applied even in averagely equipped laboratories during formulation development or preliminary bioequivalence assessment of generic topical semisolids.
PB  - Savez hemijskih inženjera, Beograd
T2  - Hemijska industrija
T1  - A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells
VL  - 72
IS  - 1
SP  - 47
EP  - 53
DO  - 10.2298/HEMIND170726019P
ER  - 
@article{
author = "Pantelić, Ivana and Ilić, Tanja and Marković, Bojan and Savić, Sanela and Lukić, Milica and Savić, Snežana",
year = "2018",
abstract = "After decades long absence of an official consensus on the most appropriate evaluation method for in vitro skin performance of topical semisolid drugs, United States Pharmacopoeia (USP 39) finally suggested three types of testing equipment; however, all these provide data on drug release using inert synthetic membranes. Considering the need for a readily available membrane that would be more structurally similar to human skin, this paper provides a detailed protocol of a method for drug permeation assessment that uses heat-separated porcine ear epidermis and modified Franz diffusion cells. Phases that were shown to be critical for variability of the results are identified (e.g., membrane preparation), and process parameters optimized. Applicability of the method was tested on four cream samples loaded with aceclofenac as a model drug. Sample compositions were designed in such a way to provide, large "variations (variation of the main stabilizer: natural-origin versus synthetic emulsifier) and relatively, minor" variations (co-solvent variation: none/isopropanol/glycerol). The developed protocol is a straightforward and reliable in vitro test for the evaluation of rate and extent of drug delivery into/through the skin. Moreover, this protocol may be routinely applied even in averagely equipped laboratories during formulation development or preliminary bioequivalence assessment of generic topical semisolids.",
publisher = "Savez hemijskih inženjera, Beograd",
journal = "Hemijska industrija",
title = "A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells",
volume = "72",
number = "1",
pages = "47-53",
doi = "10.2298/HEMIND170726019P"
}
Pantelić, I., Ilić, T., Marković, B., Savić, S., Lukić, M.,& Savić, S.. (2018). A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells. in Hemijska industrija
Savez hemijskih inženjera, Beograd., 72(1), 47-53.
https://doi.org/10.2298/HEMIND170726019P
Pantelić I, Ilić T, Marković B, Savić S, Lukić M, Savić S. A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells. in Hemijska industrija. 2018;72(1):47-53.
doi:10.2298/HEMIND170726019P .
Pantelić, Ivana, Ilić, Tanja, Marković, Bojan, Savić, Sanela, Lukić, Milica, Savić, Snežana, "A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells" in Hemijska industrija, 72, no. 1 (2018):47-53,
https://doi.org/10.2298/HEMIND170726019P . .

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