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首页> 外文期刊>Crystal growth & design >Establishing a New Method to Evaluate the Recrystallization of Nanogram Quantities of Paracetamol Printed as a Microarray Using Inkjet Printing
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Establishing a New Method to Evaluate the Recrystallization of Nanogram Quantities of Paracetamol Printed as a Microarray Using Inkjet Printing

机译：建立一种评价用喷墨印刷作为微阵列印刷为微阵列的纳克拉氨基醇的重结晶的新方法

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In pharmaceutical preformulation it is important to be able to screen a drug compound for possible solid forms (amorphous, crystal, polymorphs, salts, etc.) prior to scale-up of manufacture for formulation, and as this screening is undertaken prior to scale-up, there is often only a small amount of drug material available. Minimizing the amount of sample required for these solid form investigations is therefore of paramount importance. Typical industrial work-flows require hundreds of milligrams of compound, while a small number of research papers have suggested that new approaches based on conventional inkjet printing may allow only a few milligrams to be used, but even these small quantities of the sample may not be available in early stage drug development. Herein we report an approach based on picoliter inkjet printing. Employing paracetamol as a model compound, we illustrate how a basic solid-form screen may be run using only nanograms of material (around 6 orders of magnitude less material than used in previously reported approaches). For the first time, we were able to monitor the recrystallization of nanogram amorphous paracetamol to metastable crystalline forms II and III. Cross-polarized microscopy and Raman spectroscopy were employed to monitor the recrystallization of the paracetamol microarray. We suggest that further development of this concept may allow preformulation to occur far earlier in drug development than is currently the case, and also a more extensive parameter space to be explored using this new approach in a microarray format.
机译：在药物预染色中，重要的是能够在制备制剂的制备之前筛选用于可能的固体形式（无定形，晶体，多晶型物，盐等）的药物化合物，并且在规模之前进行该筛选UP，通常只有少量的药物可用。因此，最小化这些固体形式研究所需的样品是至关重要的。典型的工业工作流量需要数百毫克的化合物，而少数研究论文提出基于常规喷墨印刷的新方法可以仅使用几毫克，但即使这些少量的样品也可能不是可在早期药物开发中提供。在此，我们报告了一种基于Picoliter喷墨打印的方法。使用扑热息痛作为模型化合物，我们示出了如何仅使用基本的固体形式筛网，仅使用纳图（比以前报道的方法中使用的材料少约6个数量级）。首次，我们能够监测纳米非晶扑热息酰胺的重结晶至亚稳定的结晶形式II和III。使用交叉偏振显微镜和拉曼光谱法监测扑热胺微阵列的再结晶。我们建议，这种概念的进一步发展可能允许预先形成的药物开发中的比目前的情况更早，并且还可以在微阵列格式中使用这种新方法来探索更广泛的参数空间。

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