CONTROLLED RELEASE BIOPOLYMER SYSTEMS FOR TUBERCULOSIS

尽管有几种强效药物， 实现完全治愈，机会性感染，如结核病 是一个严重的全球性问题。 取得成功的主要障碍是 化疗是不依从服药。 为了解决 这个问题，我们已经调查了，如果我们可以提供 抗分枝杆菌化疗在一个或几个剂量。 我们发现一个 单剂量的异烟肼，在聚乳酸-co- 羟基乙酸（PLGA）共聚物，能够持续释放， 治疗活性水平，持续6-8周， 体外试验以及建立的体内人-小鼠模型。 在 根据目前的研究，我们希望研究一种完全无溶剂的 异烟肼/PLGA控释制剂的制备工艺 系统，目标是为6- 一个月的短程化疗方案治疗结核病。 非溶剂 配方将大大有助于在良好的条件下制备样品 生产规范（GMP），并找到更多的准备接受 FDA在计划临床试验时。 或者，我们计划使用 制剂，可提供有效水平的药物， 因此，在整个六个月的疗程中， 双月剂量。 制剂的各种技术方面， 表征这样的聚合物制剂包括在本发明中， study.

In spite of the availability of several powerful drugs, which could achieve a complete cure, opportunistic infections such as tuberculosis are a serious global problem. The main hurdle in achieving success of chemotherapy is non-compliance in taking the drugs. In order to solve this problem, we have investigated if we could deliver the antimycobacterial chemotherapy in one or few doses. We found that a single dose of isoniazid, given in an implant of a polylactic-co- glycolic acid (PLGA) co-polymer, was able to release sustained and therapeutically active levels for prolonged periods of 6-8 weeks using in vitro testing, as well as an established in vivo man-mouse model. In the current studies, we wish to investigate a totally non-solvent technique for formulation of the isoniazid/PLGA controlled release system, with the goal of developing a single-dose treatment for the 6- month short-course chemotherapy regimes for tuberculosis. A non-solvent formulation will greatly facilitate sample preparation under good manufacturing practices (GMP's), and also find more ready acceptance by the FDA when planning clinical trials. Alternatively, we plan to use preparations which can give effective levels of drug for up to 2 or 3 months and thus deliver the whole six month regimen with 2 or 3 bimonthly doses. Various technological aspects of formulation and characterizing such polymer preparations are included in the current study.