Drug Delivery Research: The Invention Cycle.
Drug Delivery Research: The Invention Cycle.
复制标题
药物输送研究：发明周期。
DOI：
10.1021/acs.molpharmaceut.6b00015
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发表时间：
2016
影响因子：
4.9
通讯作者：
Park,Kinam
中科院分区：
文献类型：
--
作者：
Park,Kinam
受控给药系统已经成功地引入了改进的配方，以更好地利用现有药物和新型生物制剂。然而，生产许多口腔产品和一些可注射仓库配方的最初成功达到了平台期，过去30年的进展缓慢。这可能是由于研制亲水性、高分子量药物，如蛋白质和核酸，用于靶向特定细胞、持续一个月的释放和脉冲式释放的困难。由于已经很好地用于小分子输送的方法不适用于大分子，是时候开发新的生物制剂方法了。提出了开发未来药物输送系统的过程，称为发明周期，它从明确定义开发某些配方的问题开始。一旦问题被明确定义，创造性的想象力就会检查所有可能的选项，并选择最佳答案和备选方案。然后，创新开始产生独特的解决方案，用于开发解决先前发现的问题的新配方。最终，新的递送系统将必须经过翻译过程，才能生产出临床使用的最终配方。发明周期还强调检查某些配方成功的原因，而不仅仅是许多系统失败的原因。实施新的发明周期需要新的机制来资助年轻一代的科学家，需要一种新的方法来确定他们的成就，从而使他们摆脱短期主义的负担。
Controlled drug delivery systems have been successful in introducing improved formulations for better use of existing drugs and novel delivery of biologicals. The initial success of producing many oral products and some injectable depot formulations, however, reached a plateau, and the progress over the past three decades has been slow. This is likely due to the difficulties of formulating hydrophilic, high molecular weight drugs, such as proteins and nucleic acids, for targeting specific cells, month-long sustained delivery, and pulsatile release. Since the approaches that have served well for delivery of small molecules are not applicable to large molecules, it is time to develop new methods for biologicals. The process of developing future drug delivery systems, termed as the invention cycle, is proposed, and it starts with clearly defining the problems for developing certain formulations. Once the problems are well-defined, creative imagination examines all potential options and selects the best answer and alternatives. Then, innovation takes over to generate unique solutions for developing new formulations that resolve the previously identified problems. Ultimately, the new delivery systems will have to go through a translational process to produce the final formulations for clinical use. The invention cycle also emphasizes examining the reasons for success of certain formulations, not just the reasons for failure of many systems. Implementation of the new invention cycle requires new mechanisms of funding the younger generation of scientists and a new way of identifying their achievements, thereby releasing them from the burden of short-termism.