University of Medicine and Pharmacy "Victor Babeş", Faculty of Pharmacy, Eftimie Murgu Square 2, Timişoara 300041, Romania.
J Pharm Biomed Anal. 2011 Sep 10;56(2):221-7. doi: 10.1016/j.jpba.2011.05.017. Epub 2011 May 23.
Thermogravimetry/derivative thermogravimetry (TG/DTG) and differential scanning calorimetry (DSC) techniques were used for assessing the compatibility between ketoprofen (KT) and several excipients as: corn starch, microcrystalline cellulose (PH 101 and PH 102), colloidal silicon dioxide, lactose (monohydrate and anhydre), polyvinylpyrrolidone K30, magnesium stearate and talc, commonly used in the pharmaceutical form. In order to investigate the possible interactions between the components, the thermal curves of KT and each selected excipients were compared with those of their 1:1 (w/w) physical mixtures. For KT, the DSC curves have shown a sharp endothermic peak at 96.8 °C which corresponds to the melting process (literature value: 94-97 °C), respectively the TG curves demonstrated a simple stage of mass loss in the temperature range of 235-400 °C. FT-IR spectroscopy and X-ray powder diffraction (XRPD) were used as complementary techniques to adequately implement and assist in interpretation of the DSC results. On the basis of thermal results, a possible interaction was found between the KT with polyvinylpyrrolidone K30 and magnesium stearate, which could influence the stability of the KT in the binary mixtures. These possible incompatibilities were confirmed by FT-IR and X-ray analysis.
热重分析/微商热重分析（TG/DTG）和差示扫描量热法（DSC）技术被用于评估酮洛芬（KT）与几种赋形剂之间的相容性，这些赋形剂包括：玉米淀粉、微晶纤维素（PH101 和 PH102）、胶体二氧化硅、乳糖（一水合物和无水物）、聚乙烯吡咯烷酮 K30、硬脂酸镁和滑石粉，这些赋形剂常用于药物制剂。为了研究各组分之间可能存在的相互作用，将 KT 和每种选定赋形剂的热曲线与它们 1:1（w/w）物理混合物的热曲线进行了比较。对于 KT，DSC 曲线在 96.8°C 处显示出一个尖锐的吸热峰，这对应于熔融过程（文献值：94-97°C），而 TG 曲线在 235-400°C 的温度范围内显示出一个简单的质量损失阶段。傅里叶变换红外光谱（FT-IR）和 X 射线粉末衍射（XRPD）被用作补充技术，以充分实施并协助解释 DSC 结果。基于热结果，发现 KT 与聚乙烯吡咯烷酮 K30 和硬脂酸镁之间可能存在相互作用，这可能会影响 KT 在二元混合物中的稳定性。这些可能的不相容性通过 FT-IR 和 X 射线分析得到了证实。
