Preparation, Characterization and Related in Vivo Release, Safety and Toxicity Studies of Long Acting Lanreotide Microspheres

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  • Wang Shuang
    China Japan Union Hospital, Jilin University China Japan Union Hospital, Jilin University
  • Wu Mingsheng
    School of Medicine, Johns Hopkins University School of Medicine, Johns Hopkins University
  • Li Dan
    School of Pharmacy, Jilin University School of Pharmacy, Jilin University
  • Jiao Mingli
    School of Public Health, Harbin Medical University School of Public Health, Harbin Medical University
  • Wang Lan
    School of Pharmaceutical Engineering, Shenyang Pharmaceutical University School of Pharmaceutical Engineering, Shenyang Pharmaceutical University
  • Zhang Haifeng
    School of Pharmacy, Jilin University School of Pharmacy, Jilin University
  • Liu HuaiYu
    Experiment Animal Center of Jilin University Experiment Animal Center of Jilin University
  • Wang Daifeng
    School of Pharmacy, Jilin University School of Pharmacy, Jilin University
  • Han Bing
    School of Pharmacy, Jilin University School of Pharmacy, Jilin University

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タイトル別名
  • Preparation, Characterization and Related <i>in Vivo</i> Release, Safety and Toxicity Studies of Long Acting Lanreotide Microspheres

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The goal of this project was to prepare long-acting lanreotide acetate poly(lactic-co-glycolic acid) (PLGA) microspheres and to analyze the in vivo and in vitro release, safety and toxicology of these preparations. Long-acting lanreotide acetate PLGA microspheres that exhibited a 5-week slow-release period were prepared by a multiple-emulsion solvent evaporation method. Physical characterization, as well as the analysis of the in vivo and in vitro release, safety, acute toxicity and chronic toxicity of the lanreotide microspheres, were conducted in animal models in rats, guinea pigs, rabbits and beagle dogs. The lanreotide acetate PLGA microspheres prepared by multiple-emulsion solvent evaporation had smooth surfaces, uniform particle size and stable lanreotide loading. In vivo and in vitro experiments showed that the lanreotide acetate PLGA microspheres could continuously release lanreotide for 5 weeks. The safety of these long acting lanreotide microspheres was good in the following animal models: active systemic anaphylaxis test in guinea pigs, passive cutaneous anaphylaxis test in rats, hemolytic test in rabbits, local skin irritation test after subcutaneous administration in rabbits and muscle stimulation test in rabbits. Furthermore, no significant acute toxicity or chronic toxicity was observed after administration of lanreotide acetate PLGA microspheres in beagle dogs at dosages up to 22 mg/kg. The lanreotide acetate PLGA microspheres that were prepared in this study exhibited beneficial characteristics in apparent property and structural stability, as well as in release trends in vivo and in vitro.

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