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Two-and Three-Layered Dissolving Microneedles for Transcutaneous Delivery of Model Vaccine Antigen in Rats

Journal of Biomaterials and Nanobiotechnology 2012年第3期3卷 325-334页

作者： Asuka Ikejiri yukako ito Seishiro Naito Kanji Takada Department of Pharmacokinetics Kyoto Pharmaceutical University Kyoto Japan Department of Safety Research on Blood and Biological Products National Institute of Infectious Diseases Tokyo Japan.

Purpose: Comparison of transcutaneous immunization of ovalbumin (OA) between two-and three-layered dissolving microneedles (MN) in rats. Methods: We prepared 500 μm long two-layered and three-layered dissolving microneedle (2-MN and 3-MN, respectively) arrays from chondroitin sulfate as the base, and OA as the model antigen. The 2-MN containing OA at the acral portion and 3-MN with OA at the second portion were administered to rat skin transcutaneously. As a positive control, OA solution was injected subcutaneously (sc). The OA delivery and diffusion in the rat skin were studied using confocal microscopy with fluorescein-conjugated OA (FL-OA). Results: The formulated positions of OA were 0-155 ± 5 μm for 2-MN and 175 ± 4 – 225 ± 5 μm for 3-MN. The administered doses of OA were 2.2 ± 0.1 μg, 12.0 ± 0.2 μg and 22.0 ± 0.2 μg for 2-MN, 1.8 ± 0.2 μg, 12.6 ± 0.7 μg, and 20.4 ± 0.3 μg for 3-MN, 10 μg, 100 μg and 1000 μg for sc injection. At 4 weeks after the first administration, 3-MN showed about 2.5-7.0 fold and 5.4 fold higher total Ig (G + A + M) antibody than 2-MN and sc injection of the OA solution. Conclusions: The 3-MN, which delivered OA to the epidermis, is a useful drug delivery system for transcutaneous antigen delivery.

关键词： Dissolving Microneedles (Mns) Two-Layered Mns Three-Layered Mns Transcutaneous Vaccine Ovalbumin Fl-Ovalbumin (Fl-Oa)

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Usefulness of Basic Fibroblast Growth Factor (bFGF) Loaded Dissolving Microneedles for Local Therapy of Skin Wounds

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Journal of Biomaterials and Nanobiotechnology 2013年第3期4卷 256-264页

作者： Kanji Takada yukako ito Kengo Matsumoto Yuka Sato Maimi Nishio Yurie Tadano Yuri Kamei Yutaro Takemura Nana Inoue Yoshiki Akasaka Ichiro Ono BioSerenTach Inc. Shimogyo- Ku Kyoto Japan Department of Dermatology Sapporo Medical University School of Medicine Chuo- Ku Sapporo Japan. Department of Pharmacokinetics Kyoto Pharmaceutical University Yamashina-Ku Kyoto Japan Department of Pharmacokinetics Kyoto Pharmaceutical University Yamashina-Ku Kyoto Japan Devision of Chronic Inflammatory Diseases Advanced Medical Research Center Toho University Graduate School of Medicine Ota-Ku Tokyo Japan

Purpose: The usefulness of dissolving microneedles (DMs) for local skin therapy by basic fibroblast growth factor (bFGF) was studied in rats. Methods: We prepared four kinds of bFGF-loaded DMs, approximately 500 μm length and 300 μm diameter at the bottom. Long-term stability and dissolution studies were performed by HPLC method. Pharmacokinetic and pharmacological evaluations were performed after administration of bFGF loaded DMs to rats. Results: The bFGF contents were 2.15 ± 0.07, 1.07 ± 0.04, 0.56 ± 0.07 and 0.12 ± 0.03 μg. The 100.2 ± 3.4%, 100.2 ± 3.3%, 99.3 ± 1.4% and 100.4 ± 3.0% of bFGF were recovered after 1, 3 and 6 months and 1 year incubation at 40°C. The bFGF was released from DMs within 5 min. In a pharmacokinetic study using 2.0 and 1.0 μg bFGF-loaded DMs, no systemic exposure of bFGF was detected. The initial bFGF concentrations in the rat skin tissue after administration of bFGF-loaded DMs to the hair-removed rat abdominal skin were 510.2 ± 20.1 ng/g wet weight for 2 μg bFGF DMs and 264.2 ± 56.5 ng/g wet weight for 1 μg DMs, declining slowly thereafter to 226.3 ± 33.5 and 105.1 ± 27.4 ng/g wet weight at 6 hr after administration. Good dose-dependency was observed. Pharmacological evaluation of bFGF-loaded DMs of 2.0, 1.0, 0.5, and 0.1 μg, in the wound healing rat model, all used DMs, but 0.1 μg DMs, showed good healing effects. Considered collectively, these results suggest the usefulness of bFGF-loaded DMs for local therapy of skin wound disease.

关键词： Basic Fibroblast Growth Factor (bFGF) Dissolving Microneedles (DMs) Transdermal Delivery Wound Healing Rats

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