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采用共处理混合物制备的口腔崩解氯雷他定片的制备及表征

PREPARATION AND CHARACTERIZATION OF ORALLY DISINTEGRATING LORATADINE TABLETS MANUFACTURED WITH CO-PROCESSED MIXTURES.

作者信息

Amelian Aleksandra, Szekalska Marta, Wilczewska Agnieszka Zofia, Basa Anna, Winnicka Katarzyna

出版信息

Acta Pol Pharm. 2016 Mar-Apr;73(2):453-60.

Abstract

The aim of this study was to develop orally disintegrated tablets (ODT) with loratadine using Parteck ODT and Ludiflash--new commercially available tableting excipients based on co-processed mannitol. ODT containing loratadine were prepared with 3% addition of various superdisintegrants (AcDiSol, Kollidon CL-F and Kollidon CL-SF) by direct compression method. Obtained tablets were characterized for friability, pore structure, and wetting and disintegration time measured by four independents methods. In order to identify possible interactions between loratadine and the excipients, differential scanning calorimetry was used. The results showed that all formulated ODT were characterized by appropriate mechanical properties (friability < 1%), the uniform content of the drug substance and pleasant mouth feeling. Disintegration time below 30 s was observed in formulations with crospovidones as disintegrant.

摘要

本研究的目的是使用Parteck ODT和Ludiflash(基于共处理甘露醇的新型市售压片辅料)开发含氯雷他定的口腔崩解片(ODT)。通过直接压片法,添加3%的各种超级崩解剂(AcDiSol、Kollidon CL-F和Kollidon CL-SF)制备含氯雷他定的ODT。通过四种独立方法对制得的片剂进行脆碎度、孔隙结构以及润湿和崩解时间的表征。为了确定氯雷他定与辅料之间可能的相互作用,采用了差示扫描量热法。结果表明,所有制备的ODT均具有合适的机械性能(脆碎度<1%)、药物均匀含量以及良好的口感。以交联聚维酮作为崩解剂的制剂崩解时间低于30秒。

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