Nootan Pharmacy College, Sankalchand Patel University, Visnagar, Gujarat, India.
Int J Pharm Compd. 2023 Jan-Feb;27(1):78-87.
The objective of this study was to prepare agglomerated isomalt by using the melt granulation process. This method involved the use of 99.5% of isomalt with the meltable binder glyceryl monostearate in a concentration of 0.5%. Glyceryl monostearate has a melting point of 50°C to 55°C, therefore, glyceryl monostearate was melted at its melting point and isomalt powder was blended with it to break the mass into agglomerates. The agglomerates were cooled to room temperature and were then screened to obtain granules of the desired size. The Fourier Transform Infrared Spectroscopy studies confirmed that the chemical structure of isomalt was not changed before and after the melt granulation process. A differential scanning calorimetry study showed that there was no appearance of more new peaks or disappearance of one or more peaks corresponding to those of the isomalt powder and agglomerated isomalt, which showed no changes in the structure of the isomalt powder before and after the agglomeration process. The agglomerated isomalt and galenIQ 721 showed almost identical solubility profiles for g of solute per 100 g of solution at different temperatures. The scanning electron microscopy analysis of agglomerated isomalt showed promising results for the preparation of agglomerates of isomalt with glyceryl monostearate. The flow properties of the agglomerated isomalt compared with the galenIQ 721 and pure isomalt powder and melt granulation process showed promising results for agglomerated isomalt. The melt granulation process showed promising results to prepare agglomerates of the isomalt with the meltable binder glyceryl monostearate.
本研究的目的是采用熔融造粒法制备结块异麦芽酮糖醇。该方法使用 99.5%的异麦芽酮糖醇和可熔性粘结剂单硬脂酸甘油酯，浓度为 0.5%。单硬脂酸甘油酯的熔点为 50°C 至 55°C，因此，在熔点下将单硬脂酸甘油酯熔化，然后将异麦芽酮糖醇粉末与之混合，将块状物破碎成团块。将团块冷却至室温，然后进行筛分，以获得所需尺寸的颗粒。傅里叶变换红外光谱研究证实，异麦芽酮糖醇的化学结构在熔融造粒前后没有改变。差示扫描量热法研究表明，没有出现更多的新峰，也没有一个或多个与异麦芽酮糖醇粉末和结块异麦芽酮糖醇相对应的峰消失，这表明在团聚过程前后异麦芽酮糖醇粉末的结构没有变化。结块异麦芽酮糖醇和 galenIQ 721 在不同温度下每 100 克溶液中溶质克数的溶解度曲线几乎相同。结块异麦芽酮糖醇的扫描电子显微镜分析结果表明，使用单硬脂酸甘油酯制备异麦芽酮糖醇团聚体具有很大的前景。与 galenIQ 721 和纯异麦芽酮糖醇粉末相比，结块异麦芽酮糖醇的流动性能显示出了令人鼓舞的结果，并且熔融造粒工艺也显示出了令人鼓舞的结果。熔融造粒工艺在制备具有可熔性粘结剂单硬脂酸甘油酯的异麦芽酮糖醇团聚体方面显示出了巨大的潜力。
