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Formulation and Evaluation of Eudragit® RL Polymeric Double Layer Films for Prolonged-Release Transdermal Delivery of Tamsulosin Hydrochloride

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Transdermal drug delivery systems (TDDSs) were developed for prolonged tamsulosin (TMS) delivery. Double layer (DL) TDDSs were prepared using Eudragit® RL by conventional film-forming. Ethylene-vinyl acetate was used as the backing layer, triethylcitrate as plasticizer, and Capmul® PG-8-70 NF and Captex 170 EP as penetration enhancers (PEs). An increase in either drug or PE concentration caused a significant increase in drug permeation flux. Modulation of drug permeation across Strat-M® membrane was examined using a single layer (SL) having the same thickness and drug content as the DLs, while the DLs were formulated to have variable drug spatial distribution across each layer (DL 4:6 and DL 6:4). SL/TDDS showed significantly higher daily drug permeation than DL/TDDSs for the first 4 days which could be related to the presence of high TMS concentration located on the upper surface of SL/TDDS as a result of solute migration of TMS during the drying process. However, this increase was followed by a progressive linear decrease after 5 days. Deflection points that were characterized by lower drug flux had been shown by SL/TDDS at more than one-point times. In contrast, DL 4:6 and DL 6:4 TDDSs demonstrated an ability to sustain TMS delivery for up to 2 weeks.

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The authors would like to acknowledge the Target Chemicals, Jordan, for donating Eudragit® RL and Al Taqaddom Pharmaceuticals Industries, Jordan, for providing tamsulosin hydrochloride.


This research was funded by the Jordan University of Science and Technology grant number 20200116.

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Authors and Affiliations



Conceptualization, Assaf S.M., and Sallam A.A.; Methodology, Assaf S.M., Khalil E.A., and Sallam A.A.; validation, Assaf S.M., Ghanem A.M., and Sallam A.A.; formal analysis, Ghanem A.M.; investigation, Ghanem A.M. and Alhaj, S.A.; resources, Ghanem A.M. and Alhaj S.A.; data curation, Assaf S.M., Ghanem A.M., and Sallam A.A.; writing – original draft preparation, Assaf S.M.; Writing – Review & Editing, Assaf S.M., Ghanem A.M., Sallam A.A.; visualization, Ghanem A.M.; supervision, Assaf A.A., Sallam A.A., and Khalil E.A.; project administration, Assaf S.M. and Sallam A.A.; funding acquisition, Assaf S.M.

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Correspondence to Shereen M. Assaf.

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Supplementary Information


SEM images of the Strat-M membrane: (A) before permeation study and after (B) one week and (C) two weeks of the permeation study at 2500x magnification power. (GIF 86 kb)


Two-week in vitro permeation profiles of TMS from P9 after storing at 5 °C (refrigerated), 30 °C/ 60% RH (30 degrees), and 40 °C/ 75% RH (40 degrees), through Strat-M® membrane into phosphate buffer (pH 6.8) at 32 ± 1 oC, compared with its permeation from a freshly prepared patch (mean ± RSD, n=3). (GIF 12 kb)

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Assaf, S.M., Ghanem, A.M., Alhaj, S.A. et al. Formulation and Evaluation of Eudragit® RL Polymeric Double Layer Films for Prolonged-Release Transdermal Delivery of Tamsulosin Hydrochloride. AAPS PharmSciTech 23, 210 (2022).

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