Bamiro Oluyemisi Adebowale, Duro-Emanuel Abioye Josephina
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Olabisi Onabanjo University, Ibadan, Nigeria.
Int J Pharm Investig. 2017 Jan-Mar;7(1):18-24. doi: 10.4103/jphi.JPHI_31_16.
The delivery of drug is often affected by formulation processes and the excipients used in the formulation.
A 2 factorial analysis was used in this study to evaluate the effect of acetylated ginger starch (AGS) () as a binder in metronidazole tablets, in comparison to corn starch (CS) BP. The individual and interacting effects of variables (binder type X, binder concentration X, and compression pressure X) used on tablet properties such as friability, crushing strength, crushing strength friability ratio (CSFR), disintegration and crushing strength friability/disintegration time ratio (CSFR/DT) were determined. The effect of these binders on the granule properties using Hausner's ratio, Carr's index (CI), angle of repose, and densities as response parameters was also determined.
Granules prepared with AGS had high densities and small granule sizes when compared with those containing CS. Granules containing CS have better flow properties. X (binder type) has a significant effect on the crushing strength of the tablet. It also had the highest effects on CSFR and CSFR/DT. The combination of XX had the highest effect on crushing strength and DT.
This study shows that, in formulations, care must be taken in choosing the excipients and the process parameters required for the formulation since these can affect the delivery of the drug individually or in combination. AGS could be useful as a binder when a tablet with low crushing strength and fast disintegration is desired.
药物的递送常常受到制剂工艺以及制剂中所用辅料的影响。
本研究采用二因素析因分析,以评估乙酰化姜淀粉(AGS)作为甲硝唑片剂黏合剂的效果,并与英国药典级玉米淀粉(CS)进行比较。确定了所使用的变量(黏合剂类型X、黏合剂浓度X和压片压力X)对片剂性质(如脆碎度、抗压强度、抗压强度脆碎度比(CSFR)、崩解度以及抗压强度脆碎度/崩解时间比(CSFR/DT))的单独及交互作用影响。还确定了这些黏合剂对颗粒性质的影响,以豪斯纳比、卡尔指数(CI)、休止角和密度作为响应参数。
与含CS的颗粒相比,用AGS制备的颗粒密度高且粒径小。含CS的颗粒具有更好的流动性。X(黏合剂类型)对片剂的抗压强度有显著影响。它对CSFR和CSFR/DT的影响也最大。XX的组合对抗压强度和崩解时间的影响最大。
本研究表明,在制剂中,选择辅料和制剂所需的工艺参数时必须谨慎,因为这些因素可能单独或共同影响药物的递送。当需要制备具有低抗压强度和快速崩解的片剂时,AGS可作为一种有用的黏合剂。