Goel Honey, Tiwary Ashok K, Rana Vikas
Pharmaceutics Division, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh (U.T.), India.
Acta Pol Pharm. 2011 Jul-Aug;68(4):571-83.
The objective of the present work was to optimize the formulation of fast disintegrating tablets (FDTs) of ondansetron HCl containing novel superdisintegrants, possessing sufficient mechanical strength and disintegration time comparable to those containing crospovidone or croscarmellose sodium. The FDTs were formulated using a novel superdisintegrant (chitosan-alginate (1:1) interpolymer complex and chitin) to achieve a sweet tasting disintegrating system. The results revealed that chitin (5-20%) increased the porosity and decreased the DT of tablets. At higher concentrations chitin maintained tablet porosity even at 5.5 kg crushing strength. Ondansetron HCl was found to antagonize the wicking action of glycine. Further, evaluation of the mechanism of disintegration revealed that glycine transported the aqueous medium to different parts of the tablets while the chitosan-alginate complex swelled up due to transfer of moisture from glycine. This phenomenon resulted in breakage of the tablet within seconds. For preparing optimized FDTs, the reduced model equations generated from Box-Behnken design (BBD) were solved after substituting the known disintegration time of FDTs containing superdisintegrants in the reduced model equations. The results suggested that excipient system under investigation not only improved the disintegration time but also made it possible to prepare FDTs with higher crushing strength as compared to tablets containing known superdisintegrants.
本研究的目的是优化含新型超级崩解剂的盐酸昂丹司琼口腔崩解片（FDT）的处方，使其具有足够的机械强度，且崩解时间与含交联聚维酮或交联羧甲基纤维素钠的片剂相当。使用新型超级崩解剂（壳聚糖-海藻酸盐（1:1）互聚物复合物和几丁质）制备FDT，以实现甜味崩解系统。结果表明，几丁质（5-20%）可增加片剂的孔隙率并缩短崩解时间。在较高浓度下，即使在5.5 kg的抗压强度下，几丁质仍能保持片剂的孔隙率。发现盐酸昂丹司琼可拮抗甘氨酸的吸湿作用。此外，对崩解机制的评估表明，甘氨酸将水性介质输送到片剂的不同部位，而壳聚糖-海藻酸盐复合物因甘氨酸中水分的转移而膨胀。这种现象导致片剂在数秒内破碎。为制备优化的FDT，将含超级崩解剂的FDT的已知崩解时间代入由Box-Behnken设计（BBD）生成的简化模型方程后求解。结果表明，所研究的辅料系统不仅缩短了崩解时间，而且与含已知超级崩解剂的片剂相比，还能够制备具有更高抗压强度的FDT。
