Abstract：
OBJECTIVE: The present research work was aimed to formulate fast disintegrating tablets (FDTs) of salbutamol sulphate (SBS) using a combination of superdisintegrant and subliming agent, optimize the formulation and evaluate the in vitro performance of the developed FDTs.
METHODS: A formulation of SBS FDT was developed using a combination of superdisintegrant - crospovidone and subliming agent - ammonium bicarbonate (AB) in which formulation variables, namely levels of crospovidone and microcrystalline cellulose (MCC):Mannitol (MNTL) ratio were evaluated for their effects on the response variables - disintegration time, hardness, friability and wetting time of the resulting FDTs. By employing a central composite design (CCD) methodology, the FDTs were optimized to achieve optimum levels of the formulation factors.
RESULTS: The desired optimum condition was obtained at 7.82% crospovidone and 70% of 1.56:1 MCC: MNTL ratio while maintaining AB at 5% level for aesthetic reasons. Under the optimized conditions, the disintegration time, hardness, friability and wetting time were 14.57±0.53 sec, 7.17±0.82 kg/cm2, 0.311% and 13.14±0.69 sec, respectively. The experimentally observed responses were found to be in close agreement with the predicted values for the optimized formulation. Moreover, the validity of the obtained optimal point was confirmed by the low magnitude of percent prediction error (<5%).
CONCLUSIONS: FDTs of SBS were successfully formulated and optimized using CCD employing a combination of superdisintegrant and subliming agents.
METHODS: A formulation of SBS FDT was developed using a combination of superdisintegrant - crospovidone and subliming agent - ammonium bicarbonate (AB) in which formulation variables, namely levels of crospovidone and microcrystalline cellulose (MCC):Mannitol (MNTL) ratio were evaluated for their effects on the response variables - disintegration time, hardness, friability and wetting time of the resulting FDTs. By employing a central composite design (CCD) methodology, the FDTs were optimized to achieve optimum levels of the formulation factors.
RESULTS: The desired optimum condition was obtained at 7.82% crospovidone and 70% of 1.56:1 MCC: MNTL ratio while maintaining AB at 5% level for aesthetic reasons. Under the optimized conditions, the disintegration time, hardness, friability and wetting time were 14.57±0.53 sec, 7.17±0.82 kg/cm2, 0.311% and 13.14±0.69 sec, respectively. The experimentally observed responses were found to be in close agreement with the predicted values for the optimized formulation. Moreover, the validity of the obtained optimal point was confirmed by the low magnitude of percent prediction error (<5%).
CONCLUSIONS: FDTs of SBS were successfully formulated and optimized using CCD employing a combination of superdisintegrant and subliming agents.
摘要：
目的：本研究工作旨在使用超级崩解剂和升华剂的组合来配制硫酸沙丁胺醇（SBS）的快速崩解片（FDTs），优化配方并评估开发的FDT的体外性能。
方法：使用超级崩解剂-交聚维酮和升华剂-碳酸氢铵（AB）的组合开发了SBSFDT的配方，即交聚维酮和微晶纤维素（MCC）的水平：甘露糖醇（MNTL）比率评估了它们对响应变量-崩解时间的影响，硬度,所得FDT的脆性和润湿时间。通过采用中央复合设计(CCD)方法，优化FDT以达到配方因子的最佳水平。
结果:在7.82%交聚维酮和70%的1.56:1MCC:MNTL比率下获得所需的最佳条件,同时出于美学原因将AB保持在5%水平。在优化条件下,崩解时间,硬度,脆性和润湿时间为14.57±0.53秒，7.17±0.82kg/cm2，0.311%和13.14±0.69秒，分别。发现实验观察到的响应与优化制剂的预测值非常一致。此外，所获得的最佳点的有效性被预测误差百分比的低幅度(<5%)所证实。
结论:SBS的FDTs使用CCD使用超级崩解剂和升华剂的组合成功地配制和优化。
方法：使用超级崩解剂-交聚维酮和升华剂-碳酸氢铵（AB）的组合开发了SBSFDT的配方，即交聚维酮和微晶纤维素（MCC）的水平：甘露糖醇（MNTL）比率评估了它们对响应变量-崩解时间的影响，硬度,所得FDT的脆性和润湿时间。通过采用中央复合设计(CCD)方法，优化FDT以达到配方因子的最佳水平。
结果:在7.82%交聚维酮和70%的1.56:1MCC:MNTL比率下获得所需的最佳条件,同时出于美学原因将AB保持在5%水平。在优化条件下,崩解时间,硬度,脆性和润湿时间为14.57±0.53秒，7.17±0.82kg/cm2，0.311%和13.14±0.69秒，分别。发现实验观察到的响应与优化制剂的预测值非常一致。此外，所获得的最佳点的有效性被预测误差百分比的低幅度(<5%)所证实。
结论:SBS的FDTs使用CCD使用超级崩解剂和升华剂的组合成功地配制和优化。
