TY  - JOUR
AU  - Ilić, Tanja
AU  - Pantelić, Ivana
AU  - Lunter, Dominique
AU  - Dodević, Sanela
AU  - Marković, Bojan
AU  - Ranković, Dragana
AU  - Daniels, Rolf
AU  - Savić, Snežana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2826
AB  - This work aimed to prove the ability of "ready-to-use" topical vehicles based on alkyl polyglucoside-mixed emulsifier (with/without co-solvent modifications) to replace the conventionally used pharmacopoeial bases (e.g., non-ionic hydrophilic cream) in compounding practice. For this purpose, considering the regulatory efforts to establish alternative, scientifically valid methods for evaluating therapeutic equivalence of topical semisolids, we performed a comparative assessment of microstructure, selected critical quality attributes (CQAs) and in vitro/in vivo product performances, by utilizing aceclofenac as a model drug. The differences in composition between investigated samples have imposed remarkable variances in monitored CQAs (particularly in the amount of aceclofenac dissolved, rheological properties and water distribution mode), reflecting the distinct differences in microstructure formed, as partially observed by polarization microscopy and confocal Raman spectral imaging. Although not fully indicative of the in vivo performances, in vitro release data (vertical diffusion vs. immersion cells) proved the microstructure peculiarities, asserting the rheological properties as decisive factor for obtained liberation profiles. Contrary, in vitro permeation results obtained using pig ear epidermis correlated well with in vivo dermatopharmacokinetic data and distinguished unequivocally between tested formulations, emphasizing the importance of skin/vehicle interactions. In summary, suggested multi-faceted approach can provide adequate proof on topical semisolids therapeutic equivalence or lack thereof.
PB  - Elsevier Science BV, Amsterdam
T2  - International Journal of Pharmaceutics
T1  - Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non) equivalence of topical semisolids: A case study of "ready-to-use" vehicles
VL  - 528
IS  - 1-2
SP  - 253
EP  - 267
DO  - 10.1016/j.ijpharm.2017.06.018
ER  - 

@article{
author = "Ilić, Tanja and Pantelić, Ivana and Lunter, Dominique and Dodević, Sanela and Marković, Bojan and Ranković, Dragana and Daniels, Rolf and Savić, Snežana",
year = "2017",
abstract = "This work aimed to prove the ability of "ready-to-use" topical vehicles based on alkyl polyglucoside-mixed emulsifier (with/without co-solvent modifications) to replace the conventionally used pharmacopoeial bases (e.g., non-ionic hydrophilic cream) in compounding practice. For this purpose, considering the regulatory efforts to establish alternative, scientifically valid methods for evaluating therapeutic equivalence of topical semisolids, we performed a comparative assessment of microstructure, selected critical quality attributes (CQAs) and in vitro/in vivo product performances, by utilizing aceclofenac as a model drug. The differences in composition between investigated samples have imposed remarkable variances in monitored CQAs (particularly in the amount of aceclofenac dissolved, rheological properties and water distribution mode), reflecting the distinct differences in microstructure formed, as partially observed by polarization microscopy and confocal Raman spectral imaging. Although not fully indicative of the in vivo performances, in vitro release data (vertical diffusion vs. immersion cells) proved the microstructure peculiarities, asserting the rheological properties as decisive factor for obtained liberation profiles. Contrary, in vitro permeation results obtained using pig ear epidermis correlated well with in vivo dermatopharmacokinetic data and distinguished unequivocally between tested formulations, emphasizing the importance of skin/vehicle interactions. In summary, suggested multi-faceted approach can provide adequate proof on topical semisolids therapeutic equivalence or lack thereof.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non) equivalence of topical semisolids: A case study of "ready-to-use" vehicles",
volume = "528",
number = "1-2",
pages = "253-267",
doi = "10.1016/j.ijpharm.2017.06.018"
}

Ilić, T., Pantelić, I., Lunter, D., Dodević, S., Marković, B., Ranković, D., Daniels, R.,& Savić, S.. (2017). Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non) equivalence of topical semisolids: A case study of "ready-to-use" vehicles. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 528(1-2), 253-267.
https://doi.org/10.1016/j.ijpharm.2017.06.018

Ilić T, Pantelić I, Lunter D, Dodević S, Marković B, Ranković D, Daniels R, Savić S. Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non) equivalence of topical semisolids: A case study of "ready-to-use" vehicles. in International Journal of Pharmaceutics. 2017;528(1-2):253-267.
doi:10.1016/j.ijpharm.2017.06.018 .

Ilić, Tanja, Pantelić, Ivana, Lunter, Dominique, Dodević, Sanela, Marković, Bojan, Ranković, Dragana, Daniels, Rolf, Savić, Snežana, "Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non) equivalence of topical semisolids: A case study of "ready-to-use" vehicles" in International Journal of Pharmaceutics, 528, no. 1-2 (2017):253-267,
https://doi.org/10.1016/j.ijpharm.2017.06.018 . .