Laboratory of Pharmaceutical Analysis, Department of Pharmaceutical Technology, School of Pharmacy, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Laboratory of Pharmaceutical Technology, Department of Pharmacy, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Pharm Dev Technol. 2021 Nov;26(9):978-988. doi: 10.1080/10837450.2021.1968431. Epub 2021 Aug 20.
To cover the unpleasant taste of amoxicillin (250 mg), maize starch (baby food) and milk chocolate were co-formulated. The raw materials and the final formulations were characterized by means of Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC) and Fourier-Transform Infrared (FT-IR) spectroscopy. To evaluate the taste masking two different groups of volunteers were used, according to the Ethical Research Committee of the Aristotle University of Thessaloniki. The optimization of excipients' content in the tablet was determined by experimental design methodology (crossed D-optimal). Due to the matrix complexity, amoxicillin was extracted using liquid extraction and analyzed isocratically by HPLC. The developed chromatographic method was validated (%Recovery 98.7-101.3, %RSD = 1.3, LOD and LOQ 0.15 and 0.45 μg mL respectively) according to the International Conference on Harmonization (ICH) guidelines. The physicochemical properties of the tablets were also examined demonstrating satisfactory quality characteristics (diameter: 15 mm, thickness: 6 mm, hardness <98 Newton, loss of mass <1.0%, disintegration time ∼25min). Additionally, dissolution (%Recovery >90) and digestion tests (%Recovery >95) were carried out. Stability experiments indicated that amoxicillin is stable in the prepared formulations for at least one year (%Recovery <91).
为了掩盖阿莫西林（250mg）的不良味道，将玉米淀粉（婴儿食品）和牛奶巧克力共同制成配方。通过动态光散射（DLS）、差示扫描量热法（DSC）和傅里叶变换红外光谱（FT-IR）对原材料和最终配方进行了表征。为了评估掩味效果，根据塞萨洛尼基亚里士多德大学伦理研究委员会的规定，使用了两组不同的志愿者。通过实验设计方法（交叉 D-最优法）确定了片剂中赋形剂含量的优化。由于基质复杂，使用液液萃取法提取阿莫西林，并通过高效液相色谱法（HPLC）等度分析。根据国际人用药品注册技术协调会（ICH）指南，对开发的色谱方法进行了验证（%Recovery 98.7-101.3，%RSD=1.3，LOD 和 LOQ 分别为 0.15 和 0.45μg mL）。还对片剂的物理化学性质进行了检查，证明具有令人满意的质量特征（直径：15mm，厚度：6mm，硬度<98 牛顿，质量损失<1.0%，崩解时间约 25min）。此外，还进行了溶出度（%Recovery>90）和消化试验（%Recovery>95）。稳定性实验表明，阿莫西林在至少一年的时间里在制备的配方中是稳定的（%Recovery<91）。
