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首页> 外文期刊>Crystal growth & design >Solid-State Phase Transition Mechanism and Physical-Chemical Study of the Crystal Forms of Monosodium Alendronate: Trihydrate versus Anhydrate
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Solid-State Phase Transition Mechanism and Physical-Chemical Study of the Crystal Forms of Monosodium Alendronate: Trihydrate versus Anhydrate

机译：阿仑膦酸钠单水合物的固态相变机理和物理化学研究：三水合物与无水物

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摘要

Alendronic acid is one of the most effective diphosphonate compounds used for clinical treatment of bone disorders. It is administered orally as its monosodium salt, for which hydrate and anhydrous crystal forms are known. The monosodium alendronate trihydrate form (NaH(4)A center dot 3H(2)O) is incorporated into medicines as the Active Pharmaceutical Ingredient (API). The NaH(4)A center dot 3H(2)O form can be dehydrated at temperatures above 115 degrees C, resulting in the anhydrous form (NaH(4)A). Although the crystal structures of both forms have already been reported, an investigation of the reversible dehydration/hydration solid-phase transition is presented here for the first time. A solid-state mechanism for the phase transition, which involves the reversible dehydration-hydration of the NaH(4)A center dot 3H(2)O and NaH(4)A forms, is also proposed. A systematic study comparing the equilibrium solubility and discriminatory intrinsic dissolution of the NaH(4)A center dot 3H(2)O and NaH(4)A forms is included. To achieve this goal, an alternative method of quantifying alendronate anions released from the crystal forms into solution, flame photometry, is proposed and validated. The stability and interconversion of the NaH(4)A center dot 3H(2)O and NaH(4)A forms are probed by differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Fourier transform infrared spectroscopy-attenuated total reflectance (FTIR-ATR), and powder X-ray diffraction (PXRD).
机译：阿仑膦酸是用于临床治疗骨疾病的最有效的二膦酸酯化合物之一。它以单钠盐口服给药，已知水合物和无水晶体形式。阿仑膦酸三钠单钠盐形式（NaH（4）A中心点3H（2）O）被掺入药物中作为活性药物成分（API）。 NaH（4）A中心点3H（2）O形式可以在高于115摄氏度的温度下脱水，形成无水形式（NaH（4）A）。尽管已经报道了两种形式的晶体结构，但是这里首次提出了可逆脱水/水合固相转变的研究。还提出了一种固态的相变机制，其中涉及NaH（4）A中心点3H（2）O和NaH（4）A形式的可逆脱水-水合。包括比较NaH（4）A中心点3H（2）O和NaH（4）A形式的平衡溶解度和区分性固有溶解的系统研究。为了实现此目标，提出并验证了另一种定量方法，该方法是定量测定从晶型释放到溶液中的阿仑膦酸阴离子的方法，即火焰光度法。 NaH（4）A中心点3H（2）O和NaH（4）A形式的稳定性和相互转换通过差示扫描量热法（DSC），热重分析（TGA），傅立叶变换红外光谱法衰减的全反射率（ FTIR-ATR）和粉末X射线衍射（PXRD）。

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