Department of Pharmaceutics and Pharmaceutical Technology, Olabisi Onabanjo University, Sagamu, Ogun, 20022, Nigeria.
Arch Pharm Res. 2010 Mar;33(3):395-403. doi: 10.1007/s12272-010-0308-0. Epub 2010 Mar 30.
A work has been done to study the individual and interacting effects of formulation variables, using a 23 fractional factorial design. The effects of five variables, namely, relative density of tablets, nature and concentration of binder, compression process, and compression speed on the tensile strength and percent survival of Bacillus subtilis spores in diclofenac tablet formulations were determined. The effects of these variables were studied both singly and when they interact with each other in two fractional designs (Woolfall, 1964). The first fraction comprised of nature (N) and concentration (C) of binder, and relative density of tablets (D) while in the second fraction, compression speed (S), compression process (P) and relative density of tablets (D) were studied. In the first fraction, concentration of binder had the highest effect on tensile strength with the ranking C > D > N for both DCS (formulation containing Corn starch) and DDCP (formulation containing DCP), and C > N > D for DL (formulation containing Lactose). On the percent survival of Bacillus subtilis, relative density of tablets showed the highest effect with the ranking D > C > N for both DCS and DL, and D > N > C for DDCP. In the second fraction, compression speed generally had a great effect on both tensile strength and percent survival in all the formulations. The results of interactions among the variables showed the highest effect on tensile strength from interaction between concentration of binder and relative density of tablets (C-D) while interaction between compression speed and relative density of tablets (S-D) had the highest effect on percent survival in all the formulations. A fractional factorial design proved suitable in determining the magnitude of both the individual and interacting effects of the variables. The study showed that each of these variables has to be properly considered in producing tablets of satisfactory strength and reduced microbial survival.
已经完成了一项工作，使用 23 部分析因设计来研究配方变量的单独和相互作用效应。研究了五个变量（即片剂的相对密度、粘合剂的性质和浓度、压缩工艺和压缩速度）对双氯芬酸钠片剂配方中枯草芽孢杆菌孢子的拉伸强度和存活率的影响。研究了这些变量的单独影响以及在两个部分析因设计（Woolfall，1964）中它们相互作用的影响。第一部分包括粘合剂的性质（N）和浓度（C）以及片剂的相对密度（D），而在第二部分中，研究了压缩速度（S）、压缩工艺（P）和片剂的相对密度（D）。在第一部分中，对于 DCS（含玉米淀粉的配方）和 DDCP（含 DCP 的配方），粘合剂浓度对拉伸强度的影响最大，排序为 C>D>N，对于 DL（含乳糖的配方），排序为 C>N>D。对于枯草芽孢杆菌的存活率，片剂的相对密度影响最大，对于 DCS 和 DL，排序为 D>C>N，对于 DDCP，排序为 D>N>C。在第二部分中，在所有配方中，压缩速度通常对拉伸强度和存活率都有很大的影响。变量之间相互作用的结果表明，粘合剂浓度与片剂相对密度之间的相互作用对拉伸强度的影响最大，而在所有配方中，压缩速度与片剂相对密度之间的相互作用对存活率的影响最大。部分析因设计证明适用于确定变量的单独和相互作用效应的大小。研究表明，在生产具有令人满意的强度和降低微生物存活率的片剂时，必须适当考虑这些变量中的每一个。
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