Cleland J L
Genentech, Inc., S. San Francisco, California 94080, USA.
Biotechnol Prog. 1998 Jan-Feb;14(1):102-7. doi: 10.1021/bp970128t.
Novel drug delivery technologies have now evolved to allow the clinical production of new dosage forms. One new form, biodegradable microspheres, may have utility as a second-generation formulation for parenterally administered proteins and peptides or may be required for the success of some new chemical entities. Here, we have focused on the use of poly(lactic-co-glycolic acid) (PLGA) microspheres to provide a continuous delivery of therapeutic proteins or a pulsatile delivery of protein-based vaccines. To date, our success with solvent evaporation processes has been primarily in the production of microspheres with a triphasic protein release pattern instead of a continuous release. However, with continued development efforts, this method may be used to produce continuous release protein formulations. While this review draws from our own work, there is a great deal of excellent research in this area at both universities and industrial laboratories. This work combined with our studies indicates that this technology holds much promise for new protein formulations that will provide improvements in patient care and, perhaps, increased efficacy.
新型药物递送技术现已发展到能够实现新剂型的临床生产。一种新剂型，即可生物降解微球，可能作为第二代肠胃外给药蛋白质和肽的制剂，或者某些新化学实体成功应用可能需要它。在此，我们专注于使用聚乳酸 - 乙醇酸共聚物（PLGA）微球来实现治疗性蛋白质的持续递送或基于蛋白质疫苗的脉冲式递送。到目前为止，我们在溶剂蒸发工艺方面的成功主要在于生产具有三相蛋白质释放模式而非持续释放的微球。然而，随着持续的研发努力，该方法可能用于生产持续释放的蛋白质制剂。虽然本综述借鉴了我们自己的工作，但在大学和工业实验室的这一领域都有大量出色的研究。这项工作与我们的研究相结合表明，这项技术对于新的蛋白质制剂具有很大的前景，有望改善患者护理并可能提高疗效。
