O'Connor R E, Schwartz J B
Department of Pharmaceutics, School of Pharmacy, Philadelphia College of Pharmacy & Science, Pennsylvania 19104.
Pharm Res. 1993 Mar;10(3):356-61. doi: 10.1023/a:1018928003668.
A common form of modified release is the encapsulation of specially formulated or coated pellets. An important first step in the development of a multiparticulate coated dosage form is to characterize the uncoated pellet. In earlier work, an uncoated pellet system developed in these laboratories and prepared from microcrystalline cellulose (MCC) was investigated and found to exhibit both the physical characteristics of an inert matrix and varying degrees of in vitro modified release. The use and characterization of MCC as a spheronization matrix material forms the basis for this formulation study. The drug release mechanism has been verified by varying selected formulation factors and evaluating the resulting pellets according to the relationship developed by T. Higuchi for granular inert matrices. In all cases, this MCC pellet system adhered to the theoretical relationships and the drug release mechanism can, therefore, be classified as an inert matrix.
一种常见的缓释形式是对特殊配方或包衣的小丸进行封装。开发多颗粒包衣剂型的重要第一步是对未包衣小丸进行表征。在早期工作中，对在这些实验室开发并由微晶纤维素（MCC）制备的未包衣小丸系统进行了研究，发现其既具有惰性基质的物理特性，又具有不同程度的体外缓释特性。使用MCC作为滚圆基质材料并对其进行表征，构成了本制剂研究的基础。通过改变选定的制剂因素，并根据T. Higuchi为颗粒状惰性基质建立的关系评估所得小丸，药物释放机制得到了验证。在所有情况下，这种MCC小丸系统都符合理论关系，因此药物释放机制可归类为惰性基质。
