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El-Say KM, Ahmed TA, Badr-Eldin SM, et al. Enhanced permeation parameters of optimized nanostructured simvastatin transdermal films: ex vivo and in vivo evaluation. Pharm Dev Technol. 2014;20(8):919-926doi: 10.3109/10837450.2014.938859.
El-Say, K. M., Ahmed, T. A., Badr-Eldin, S. M., Fahmy, U., Aldawsari, H., & Ahmed, O. A. A. (2015). Enhanced permeation parameters of optimized nanostructured simvastatin transdermal films: ex vivo and in vivo evaluation. Pharmaceutical development and technology, 20(8), 919-926. https://doi.org/10.3109/10837450.2014.938859
El-Say, Khalid M, et al. "Enhanced permeation parameters of optimized nanostructured simvastatin transdermal films: ex vivo and in vivo evaluation." Pharmaceutical development and technology vol. 20,8 (2015): 919-926. doi: https://doi.org/10.3109/10837450.2014.938859
El-Say KM, Ahmed TA, Badr-Eldin SM, Fahmy U, Aldawsari H, Ahmed OAA. Enhanced permeation parameters of optimized nanostructured simvastatin transdermal films: ex vivo and in vivo evaluation. Pharm Dev Technol. 2015 Dec;20(8):919-926. doi: 10.3109/10837450.2014.938859. Epub 2014 Jul 14. PMID: 25019166.
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Pharm Dev Technol. 2015 Dec;20(8):919-926. doi: 10.3109/10837450.2014.938859. Epub 2014 Jul 14.

Enhanced permeation parameters of optimized nanostructured simvastatin transdermal films: ex vivo and in vivo evaluation.

Pharmaceutical development and technology

Khalid M El-Say, Tarek A Ahmed, Shaimaa M Badr-Eldin, Usama Fahmy, Hibah Aldawsari, Osama A A Ahmed

Affiliations

  1. a Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , King Abdulaziz University , Jeddah , Saudi Arabia.
  2. b Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Al-Azhar University , Cairo , Egypt.
  3. c Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Cairo University , Cairo , Egypt , and.
  4. d Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Minia University , Minia , Egypt.

PMID: 25019166 DOI: 10.3109/10837450.2014.938859

Abstract

OBJECTIVE: Detailed optimization process was carried out to enhance permeation parameters, and hence bioavailability, of simvastatin (SMV) transdermal films.

METHODS: SMV solubility was investigated in various oils, surfactants and co-surfactants/co-solvents. Mixtures of the selected components were prepared to identify zone of nanoemulsion formation that was utilized in Extreme Vertices mixture design to develop SMV self-nanoemulsifying drug delivery systems (SNEDDS) with minimum globule size. Optimized SMV-SNEDDS were included in the preparation of transdermal films. A fractional factorial design was implemented to evaluate effects of the factors on the amount of SMV permeated. The optimized film was investigated for ex vivo skin permeation and in vivo pharmacokinetic parameters.

RESULTS: The optimum SNEDDS formula was 0.09, 0.8 and 0.11 for Sefsol 218, tween 80 and PEG 200, respectively. Fractional factorial design depicted the optimized SMV transdermal film with 2% HPMC and 2% DMSO as permeation enhancer that showed 1.82-fold improvements in skin flux. The pharmacokinetic data showed higher C

CONCLUSION: The two-step optimization implemented to optimize and control the experimental conditions for the preparation of SMV-SNEDDS-transdermal film with improved ex vivo skin permeation and enhanced in vivo parameters.

Keywords: Fractional factorial design; SNEDDS; mixture design; simvastatin; transdermal film

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