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Volume 34 Issue 2
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2016  >  34(2): 142-147,170

LIU Zhihong, HU Xiongwei, TAO Chun, ZHANG Jing, SONG Hongtao. Studies on sirolimus self-microemulsifying drug delivery system and its solidification[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 142-147,170. doi: 10.3969/j.issn.1006-0111.2016.02.012
Citation: LIU Zhihong, HU Xiongwei, TAO Chun, ZHANG Jing, SONG Hongtao. Studies on sirolimus self-microemulsifying drug delivery system and its solidification[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 142-147,170. doi: 10.3969/j.issn.1006-0111.2016.02.012
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Studies on sirolimus self-microemulsifying drug delivery system and its solidification

doi: 10.3969/j.issn.1006-0111.2016.02.012

  • Department of Pharmacy, Fuzhou General Hospital of Nanjing Command PLA, Fuzhou 350025, China

  • Received Date: 2016-01-01
  • Rev Recd Date: 2016-01-31
  • Objective To screen the formulation of self-microemulsifying drug delivery system(SMEDDS) for sirolimus(SRL) and prepare the SRL-SMEDDS pellets. Methods Co-emulsifier, oil phase and emulsifier were chosen by solubility test and ternary phase diagrams, central composite design and response surface method were adopted to screen and optimize the preparation and formulation of liquid SRL-SMEDDS. The selected liquid SRL-SMEDDS formulations were prepared into pellets by extrusion-spheronization method. Results The final pellets from liquid SRL-SMEDDS formulation:SRL 0.4%, Labrafil M1944CS 9.3%, Cremophor EL 15.9%, Transcutol P 8.0%, MCC 49.8%, lactose 13.3%, CMS-Na 3.3%. Dissolution test showed superphosphate(SSP) in the dissolution water is much greater than the commercially available sirolimus tablets; while in 0.4% SDS solution, the two formulations showed similar dissolution. Conclusion SMEDDS can improve the dissolution of SRL in vitro.
  • [1] Rial MC,Abbud-Filho M,Goncalves RT,et al. Individualizing early use of sirolimus in renal transplantation[J]. Transplant Proc,2010,42(10):4518-4525.
    [2] Toso C,Merani S,Bigam DL,et al. Sirolimus-based immunosuppression is associated with increased survival after liver transplantation for hepatocellular carcinoma[J].Hepatology,2010,51(4):1237-1243.
    [3] Chatel MA,Larkin DF. Sirolimus and mycophenolate as combination prophylaxis in corneal transplant recipients at high rejection risk[J]. Am J Ophthalmol,2010,150(2):179-184.
    [4] Chen Y,Li G,Wu X,et al. Self-microemulsifying drug delivery system(SMEDDS)of vinpocetine:formulation development and in vivo assessment[J]. Biol Pharm Bull,2008,31(1):118-125.
    [5] Patel AR,Vavia PR. Preparation and in vivo evaluation of SMEDDS(self-microemuldifying drug delivery system)containing fenofibrate[J].AAPS J,2007,9(3):344-352.
    [6] Woo JS,Song YK,Hong JY,et al. Reduced food-effect and enhanced bioavailability of a self-microemulsifying formulation of itraconazole in healthy volunteers[J]. Eur J Pharm Sci,2008,33(2):159-165.
    [7] 温许,黄爱文,张敏新,等. 西罗莫司固体自微乳口服缓释微丸的制备与体外释药考察[J]. 中国医院药学杂志,2014,34(23):1998-2003.
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Studies on sirolimus self-microemulsifying drug delivery system and its solidification

doi: 10.3969/j.issn.1006-0111.2016.02.012
  • Department of Pharmacy, Fuzhou General Hospital of Nanjing Command PLA, Fuzhou 350025, China
  • Received Date: 2016-01-01
  • Rev Recd Date: 2016-01-31

Abstract: Objective To screen the formulation of self-microemulsifying drug delivery system(SMEDDS) for sirolimus(SRL) and prepare the SRL-SMEDDS pellets. Methods Co-emulsifier, oil phase and emulsifier were chosen by solubility test and ternary phase diagrams, central composite design and response surface method were adopted to screen and optimize the preparation and formulation of liquid SRL-SMEDDS. The selected liquid SRL-SMEDDS formulations were prepared into pellets by extrusion-spheronization method. Results The final pellets from liquid SRL-SMEDDS formulation:SRL 0.4%, Labrafil M1944CS 9.3%, Cremophor EL 15.9%, Transcutol P 8.0%, MCC 49.8%, lactose 13.3%, CMS-Na 3.3%. Dissolution test showed superphosphate(SSP) in the dissolution water is much greater than the commercially available sirolimus tablets; while in 0.4% SDS solution, the two formulations showed similar dissolution. Conclusion SMEDDS can improve the dissolution of SRL in vitro.

LIU Zhihong, HU Xiongwei, TAO Chun, ZHANG Jing, SONG Hongtao. Studies on sirolimus self-microemulsifying drug delivery system and its solidification[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 142-147,170. doi: 10.3969/j.issn.1006-0111.2016.02.012
Citation: LIU Zhihong, HU Xiongwei, TAO Chun, ZHANG Jing, SONG Hongtao. Studies on sirolimus self-microemulsifying drug delivery system and its solidification[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(2): 142-147,170. doi: 10.3969/j.issn.1006-0111.2016.02.012
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