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      Proniosome-derived niosomes for tacrolimus topical ocular delivery: in vitro cornea permeation, ocular irritation, and in vivo anti-allograft rejection.

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          Abstract

          The objective of this study was to develop proniosome-derived niosomes for topical ophthalmic delivery of Tacrolimus (FK506). The FK506 loaded proniosomes containing poloxamer 188 and lecithin as surfactants, cholesterol as a stabilizer, and minimal amount of ethanol and trace water reconstituted to niosomes prior to use. The stability of FK506 loaded proniosomes was assessed, and the morphology, size, zeta potential, surface tension, and entrapment efficiency of the derived niosomes were characterized, indicating they were feasible for instillation in the eyes. The in vitro permeation of FK506 through the freshly excised rabbit cornea, the cumulative permeation amount of FK506 from niosomes, and the drug retention in the cornea all exhibited significant increase as compared to 0.1% FK506 commercial ointments. The in vivo ocular irritation test of 0.1% FK506 loaded niosomes instilled 4 times per day in rat eyes for 21 consecutive days showed no irritation and good biocompatibility with cornea. The in vivo anti-allograft rejection assessment was performed in a Sprague-Dawley (SD) rat corneal xenotransplantation model. The results showed treatment with 0.1% FK506 loaded niosomes delayed the occurrence of corneal allograft rejection and significantly prolonged the median survival time of corneal allografts to13.86±0.80days as compared with those treated with 1% Cyclosporine (CsA) eye drops, drug-free niosomes, or untreated. In conclusion, the proniosome-derived niosomes may be a promising vehicle for effective ocular drug delivery of FK506.

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          Author and article information

          Journal
          Eur J Pharm Sci
          European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
          Elsevier BV
          1879-0720
          0928-0987
          Oct 01 2014
          : 62
          Affiliations
          [1 ] School of Pharmaceutical Science, Sun Yat-sen University, Guangzhou 510006, China.
          [2 ] State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.
          [3 ] School of Pharmaceutical Science, Sun Yat-sen University, Guangzhou 510006, China. Electronic address: lssxyh@mail.sysu.edu.cn.
          Article
          S0928-0987(14)00225-5
          10.1016/j.ejps.2014.05.020
          24905830
          aae39cfd-aa97-4904-ae9e-7f4747ae8736
          History

          Allograft rejection,Tacrolimus,Ocular delivery,Niosome,Proniosome

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