Duloxetine hydrochloride (DLX) is a serotonin and noradrenalin reuptake inhibitor mostly used for the treatment of major depressive and anxiety disorders. Physicochemical characterization of this drug and compatibility studies with excipients are particularly important during pharmaceutical technology development in order to guarantee the quality, safe and effective dosage form. Duloxetine is acid labile, thus the final product must be formulated with enteric coating to prevent degradation in the stomach for proper drug delivery. The major purpose of this work was to characterize this drug in solid-state form through thermal analytical techniques (TG/DTG, DSC), diffuse reflectance infrared Fourier transform (DRIFT) spectrophotometry, morphological analysis by scanning electron microscopy (SEM) and x-ray diffraction (XRD) analysis. The compatibility studies with excipients (1:1 w/w) was carried out using sodium starch glycolate (SSG), lactose (LAC), magnesium stearate (MS), croscarmellose sodium (CS), colloidal silicon dioxide (CSD) and microcrystalline cellulose (MCC). For DLX, the DSC analysis showed a sharp endothermic peak corresponding to the melting process (Tpeak = 168.93°C) and purity determination of 98.74 ± 0.03%. Thermogravimetry (TG) curves revealed a mass loss of approximately 58% during thermal decomposition and the non-isothermal kinetics revealed estimated Ea of 62.73 kJ mol-1 with a reaction order of zero, indicating that DLX thermal decomposition is constant over time, regardless of its concentration. The compatibility results suggest an interaction between DLX and selected excipients (SSG, CS, CSD, MCC) evidenced by the DLX melting point dislocation on the DSC curves.

中文翻译：

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盐酸度洛西汀表征和相容性研究的热分析方法

度洛西汀盐酸盐 (DLX) 是一种血清素和去甲肾上腺素再摄取抑制剂，主要用于治疗重度抑郁症和焦虑症。为了保证剂型的质量、安全和有效，该药物的理化特性以及与赋形剂的相容性研究在制药技术开发过程中尤为重要。度洛西汀是酸不稳定的，因此最终产品必须配制成肠溶衣，以防止在胃中降解，以实现正确的药物递送。这项工作的主要目的是通过热分析技术（TG/DTG、DSC）、漫反射红外傅立叶变换 (DRIFT) 分光光度法、扫描电子显微镜 (SEM) 和 x-射线衍射（XRD）分析。使用羟基乙酸淀粉钠 (SSG)、乳糖 (LAC)、硬脂酸镁 (MS)、交联羧甲基纤维素钠 (CS)、胶体二氧化硅 (CSD) 和微晶纤维素进行与赋形剂 (1:1 w/w) 的相容性研究(MCC)。对于 DLX，DSC 分析显示对应于熔化过程的尖锐吸热峰 (Tpeak = 168.93°C) 和 98.74 ± 0.03% 的纯度测定。热重 (TG) 曲线显示热分解过程中质量损失约 58%，非等温动力学显示估计 Ea 为 62.73 kJ mol-1，反应级数为零，表明 DLX 热分解随时间是恒定的，无论它的浓度。相容性结果表明 DLX 与选定的赋形剂（SSG、CS、CSD、