Zubair S, Esezobo S, Pilpel N
Chelsea Department of Pharmacy, King's College, University of London, UK.
J Pharm Pharmacol. 1988 Apr;40(4):278-81. doi: 10.1111/j.2042-7158.1988.tb05243.x.
A factorially designed scheme has been used to analyse the separate and combined effects of packing fraction (P), nature of binder (N) and concentration of binder (C) on the tensile strength, disintegration and dissolution (t50%) times of paracetamol tablets. In general, P has the greatest effect on tensile strength, disintegration and dissolution times followed by C then N. For the variables in combination, the ranking of the effects on tensile strength, for the PVP/gelatin formulations, are P x N greater than N x C greater than P x C and for the PVP/tapioca formulations are P x C = N x C greater than P x N. For disintegration and for dissolution, the ranking for the PVP/gelatin formulations are P x C greater than P x N = N x C and P x N greater than P x C greater than N x C, respectively, and for the PVP/tapioca formulations are P x N greater than N x C = P x C. The results also show that tapioca acts as a binding agent when included in paracetamol tablet formulations, but it is a weaker binder than either PVP or gelatin. It is thus required in a higher concentration to produce tablets of comparable physical properties with those formulated with PVP or gelatin.
采用析因设计方案分析了填充率(P)、黏合剂性质(N)和黏合剂浓度(C)对扑热息痛片拉伸强度、崩解和溶出(t50%)时间的单独及联合作用。总体而言,P对拉伸强度、崩解和溶出时间的影响最大,其次是C,然后是N。对于联合变量,对于聚乙烯吡咯烷酮/明胶制剂,对拉伸强度影响的排序为P×N大于N×C大于P×C;对于聚乙烯吡咯烷酮/木薯淀粉制剂,排序为P×C = N×C大于P×N。对于崩解和溶出,对于聚乙烯吡咯烷酮/明胶制剂,排序分别为P×C大于P×N = N×C和P×N大于P×C大于N×C;对于聚乙烯吡咯烷酮/木薯淀粉制剂,排序为P×N大于N×C = P×C。结果还表明,木薯淀粉在扑热息痛片制剂中用作黏合剂时,但它是比聚乙烯吡咯烷酮或明胶更弱的黏合剂。因此,需要更高的浓度才能生产出与用聚乙烯吡咯烷酮或明胶配制的片剂具有相当物理性质的片剂。