Torres Suárez A I, Gil Alegre M E, Camacho Sánchez M A
Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, Complutense University of Madrid, Spain.
Pharm Acta Helv. 1994 Oct;69(2):101-5. doi: 10.1016/0031-6865(94)90008-6.
The pharmaceutical development of tablets of a 1,8 naphtalimide with antineoplastic activity is carried out in two steps. The preformulation step includes the study of those characteristics of the drug with special importance for the successful development of the formulation step. In this way, the low moisture, the low porosity and the good flowability of the drug as raw material allow direct compression to be taken into account, together with wet granulation as methods of tablet manufacture. As a result of the formulation studies, one formulation of tablets obtained by direct compression and another one obtained by wet granulation are selected. Both of them meet all the requirements imposed to a solid pharmaceutical form for oral administration.
一种具有抗肿瘤活性的1,8 - 萘二甲酰亚胺片剂的药物研发分两个步骤进行。处方前研究步骤包括研究药物的那些对制剂步骤的成功研发具有特别重要意义的特性。这样，作为原料的药物的低水分含量、低孔隙率和良好的流动性使得直接压片以及湿法制粒这两种片剂制造方法都得以考虑。作为制剂研究的结果，选择了一种通过直接压片获得的片剂配方和另一种通过湿法制粒获得的片剂配方。它们都满足对口服固体药物剂型所施加的所有要求。
