Akin-Ajani Olufunke D, Itiola Oludele A, Odeku Oluwatoyin A
Department of Pharmaceutics & Industrial Pharmacy, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria.
AAPS PharmSciTech. 2005 Oct 22;6(3):E458-63. doi: 10.1208/pt060357.
The effects of plantain starch obtained from the unripe fruit of the plant Musa paradisiaca L. (Musaceae) on the mechanical and disintegration properties of paracetamol tablets have been investigated in comparison with the effects of corn starch BP using a 2(3) factorial experimental design. The individual and combined effects of nature of starch binder (N), concentration of starch binder (C), and the relative density of tablet (RD) on the tensile strength (TS), brittle fracture index (BFI), and disintegration time (DT) of the tablets were investigated. The ranking of the individual effects on TS was RD > C >> N, on BFI was C >> RD > N and on DT was N > C > RD. The ranking for the interaction effects on TS and DT was N-C >> N-RD > C-RD, while that on BFI was N-C >> C-RD > N-RD. Changing nature of starch from a "low" (plantain starch) to a "high" (corn starch) level, increasing the concentration of starch binding agent from 2.5% to 10.0% wt/wt, and increasing relative density of the tablet from 0.80 to 0.90, led to increase in the values of TS and DT, but a decrease in BFI. Thus, tablets containing plantain starch had lower tensile strength and disintegration time values than those containing corn starch, but showed better ability to reduce the lamination and capping tendency in paracetamol tablet formulation. The interaction between N and C was significantly (P < .001) higher than those between N and RD and between C and RD. There is therefore the need to carefully choose the nature (N) and concentration (C) of starch used as binding agent in tablet formulations to obtain tablets of desired bond strength and disintegration properties. Furthermore, plantain starch could be useful as an alternative binding agent to cornstarch, especially where faster disintegration is required and the problems of lamination and capping are of particular concern.
采用2(3)析因试验设计,研究了从大蕉(芭蕉科,Musa paradisiaca L.)未成熟果实中提取的车前草淀粉对扑热息痛片机械性能和崩解性能的影响,并与玉米淀粉BP的影响进行了比较。研究了淀粉粘合剂性质(N)、淀粉粘合剂浓度(C)和片剂相对密度(RD)对片剂抗张强度(TS)、脆碎度指数(BFI)和崩解时间(DT)的单独和综合影响。对TS的个体效应排序为RD > C >> N,对BFI的排序为C >> RD > N,对DT的排序为N > C > RD。对TS和DT的交互效应排序为N-C >> N-RD > C-RD,而对BFI的排序为N-C >> C-RD > N-RD。将淀粉性质从“低”(车前草淀粉)变为“高”(玉米淀粉)水平,将淀粉粘合剂浓度从2.5%(重量/重量)提高到10.0%,以及将片剂相对密度从0.80提高到0.90,导致TS和DT值增加,但BFI降低。因此,含车前草淀粉的片剂的抗张强度和崩解时间值低于含玉米淀粉的片剂,但在扑热息痛片剂配方中显示出更好的减少分层和裂片倾向的能力。N和C之间的相互作用显著(P < 0.001)高于N和RD之间以及C和RD之间的相互作用。因此,在片剂配方中需要仔细选择用作粘合剂的淀粉的性质(N)和浓度(C),以获得具有所需粘结强度和崩解性能的片剂。此外,车前草淀粉可用作玉米淀粉的替代粘合剂,特别是在需要更快崩解且分层和裂片问题特别受关注的情况下。