Beijnen J H, Flora K P, Halbert G W, Henrar R E, Slack J A
Department of Pharmacy, Slotervaart Hospital/Netherlands Cancer Institute, Amsterdam.
Br J Cancer. 1995 Jul;72(1):210-8. doi: 10.1038/bjc.1995.305.
The pharmaceutical formulation of a new anti-tumour agent has often been perceived as the bottleneck in anti-cancer drug development. In order to increase the speed of this essential development step, the Cancer Research Campaign (CRC), the European Organization for Research and Treatment of Cancer (EORTC) and the National Cancer Institute (NCI) agreed in 1987 to form the Joint Formulation Working Party (JFWP). The main goal of the JFWP is to facilitate the rapid progress of a new drug through pharmaceutical developmental to preclinical toxicology and subsequently to phase I clinical trial. Under the auspices of the JFWP around 50 new agents have been developed or are currently in development. In this report we present our formulation experiences since the establishment of the JFWP with a selected number of agents: aphidicolin glycinate, bryostatin 1, carmethizole, carzelesin, combretastatin A4, dabis maleate, disulphonated aluminium phthalocyanine, E.O.9, 4-hydroxyanisole, pancratistatin, rhizoxin, Springer pro-drug, SRI 62-834, temozolomide, trimelamol and V489. The approaches used and problems presented may be of general interest to scientists in related fields and those considering submitting agents for development.
新型抗肿瘤药物的制剂常常被视为抗癌药物研发的瓶颈。为了加快这一关键研发步骤的速度，癌症研究运动组织（CRC）、欧洲癌症研究与治疗组织（EORTC）和美国国立癌症研究所（NCI）于1987年商定成立联合制剂工作组（JFWP）。JFWP的主要目标是促进新药从药物研发快速推进到临床前毒理学研究，进而进入I期临床试验。在JFWP的支持下，已经开发了约50种新药或目前正在进行研发。在本报告中，我们介绍了自JFWP成立以来，我们对选定的一些药物的制剂经验，这些药物包括：甘氨脱氧胸苷、苔藓抑素1、卡美噻唑、卡泽雷生、康普瑞他汀A4、马来酸达比斯、二磺化铝酞菁、E.O.9、4-羟基茴香醚、喷司他汀、根赤壳菌素、施普林格前体药物、SRI 62 - 834、替莫唑胺、曲美拉莫和V489。所采用的方法和出现的问题可能会引起相关领域科学家以及那些考虑提交药物进行研发的人员的普遍关注。
