Yun Samuel, Huang John J
Dev Ophthalmol. 2016;55:84-92. doi: 10.1159/000434692. Epub 2015 Oct 26.
Several different technologies exist for sustained-release drug delivery devices, including: (1) nonbiodegradable implants; (2) biodegradable implants; (3) micro- and nanoparticles; (4) liposomes, and (5) encapsulated cell technology (ECT). Currently, the only sustained-release devices approved by the Food and Drug Administration are the ganciclovir implant for the treatment of cytomegalovirus retinitis, the fluocinolone acetonide implant for the treatment of noninfectious posterior uveitis and the dexamethasone implant for the treatment of diabetic macular edema or noninfectious posterior uveitis. The first two implants are nonbiodegradable and require surgical placement, whereas the dexamethasone implant is biodegradable, and can be shaped and injected using a small-gauge needle or applicator into the vitreous. ECT, currently in a phase II clinical trial, utilizes modified retinal pigment epithelium cells to produce protein drug molecules in the vitreous. The microparticle, nanoparticle and liposome technology currently in development may offer the most flexibility for prolonged drug release and combination therapy for retinal diseases.
用于缓释药物递送装置的技术有几种,包括:(1) 不可生物降解植入物;(2) 可生物降解植入物;(3) 微米和纳米颗粒;(4) 脂质体,以及 (5) 封装细胞技术 (ECT)。目前,美国食品药品监督管理局批准的唯一缓释装置是用于治疗巨细胞病毒性视网膜炎的更昔洛韦植入物、用于治疗非感染性后葡萄膜炎的醋酸氟轻松植入物以及用于治疗糖尿病性黄斑水肿或非感染性后葡萄膜炎的地塞米松植入物。前两种植入物是不可生物降解的,需要通过手术放置,而地塞米松植入物是可生物降解的,可以使用小口径针头或涂抹器塑形并注入玻璃体。目前处于 II 期临床试验的 ECT 利用经修饰的视网膜色素上皮细胞在玻璃体内产生蛋白质药物分子。目前正在研发的微粒、纳米颗粒和脂质体技术可能为视网膜疾病的长期药物释放和联合治疗提供最大的灵活性。