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首页> 外文期刊>Journal of Crystal Growth >Control of polymorphism in the anti-solvent crystallization with a particular temperature profile
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Control of polymorphism in the anti-solvent crystallization with a particular temperature profile

机译：在特定温度曲线下控制反溶剂结晶中的多态性

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摘要

Anti-solvent crystallization is widely used in the pharmaceutical industry for high yield production. However, addition methods to control polymorph in anti-solvent crystallization have not been discussed enough. In this study, indomethacin (IMC), which has three polymorphs (α-form, α'-form and γ-form) was used. The purpose of this study is to establish a production method of the required polymorph (γ-form). Acetone was used as the original solvent and heptane was used as the anti-solvent. In order to prevent the α- or α'-form deposition, the solution compositions must not exceed the solubility of the α- or α'-form, respectively. A simulation was performed to determine the anti-solvent addition rate, which satisfies these solution conditions based on the ternary phase diagram. Experiments were carried out using four different kinds of addition methods. Method A, B and C were performed under isothermal condition but they have different anti-solvent addition methods. Method D was continuous addition at the constant rate with a particular temperature profile. In order to determine both the anti-solvent addition rate and a temperature profile, the temperature dependent ternary phase diagram was determined. Using this phase diagram and the simulation, the required polymorph was successfully obtained in the anti-solvent crystallization with a certain level of yield.
机译：反溶剂结晶在制药工业中广泛用于高产率生产。然而，关于在反溶剂结晶中控制多晶型物的添加方法的讨论还不够多。在这项研究中，使用具有三种多晶型物（α-型，α'-型和γ-型）的吲哚美辛（IMC）。本研究的目的是建立所需多晶型物（γ-形式）的生产方法。丙酮用作原始溶剂，庚烷用作抗溶剂。为了防止α-或α'形式的沉积，溶液组合物必须分别不超过α-或α'形式的溶解度。进行模拟以确定抗溶剂添加速率，其基于三元相图满足这些溶液条件。使用四种不同的添加方法进行了实验。方法A，B和C在等温条件下进行，但它们具有不同的抗溶剂添加方法。方法D是在特定温度曲线下以恒定速率连续添加。为了确定抗溶剂的添加速率和温度曲线，确定了与温度有关的三元相图。使用该相图和模拟，可以在反溶剂结晶中以一定的产率成功获得所需的多晶型物。

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