A novel white film for pharmaceutical coating formed by interaction of calcium lactate pentahydrate with hydroxypropyl methylcellulose.
A novel white film for pharmaceutical coating formed by interaction of calcium lactate pentahydrate with hydroxypropyl methylcellulose.
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DOI：
10.1016/j.ijpharm.2006.02.058
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发表时间：
2006-07
影响因子：
5.8
通讯作者：
Yukoh Sakata;S. Shiraishi;M. Otsuka
中科院分区：
文献类型：
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作者：
Yukoh Sakata;S. Shiraishi;M. Otsuka
我们发现，当使用由羟丙基甲基纤维素（HPMC）、聚乙二醇（PEG 6000）和五水乳酸钙（CLP）组成的涂层溶液时，片剂上会形成一层白色薄膜。在由HPMC和CLP组成的铸膜中也发现了白色膜，并且表明PEG 6000的加入对包衣片的表面状态有强烈的影响。本研究的目的是探讨这种白色薄膜的形成机制，以便得出合适的薄膜处方。采用差示扫描量热法（DSC）、粉末x射线衍射（PXRD）和傅里叶变换红外光谱（FT-IR）研究了膜中基片成分之间的相互作用。用HPMC和大量过量的PEG 6000形成的铸造膜在形态上是结晶的。而由HPMC、peg6000和过量的CLP组成的非晶态膜由于过量的CLP而呈现出结晶性薄膜。虽然结晶膜有许多裂纹，但非晶膜作为片剂涂层表现优异。通过对HPMC、CLP和PVP组成的铸造膜的FT-IR分析，确定了HPMC和CLP之间最可能的相互作用位点。
We have found that a white film forms on tablets when a coating solution consisting of hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG 6000) and calcium lactate pentahydrate (CLP) is used. The white film has also been found in casting film consisting of HPMC and CLP, and the surface state of coated tablets has been shown to be strongly affected by addition of PEG 6000. The aim of the present study was to investigate the mechanism of formation of this white film in order to derive an appropriate film prescription. Interaction among the base ingredients of the film was investigated using differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD) and Fourier transform-infrared (FT-IR) spectroscopy. The casting film formed with HPMC and a large excess of PEG 6000 was found to be crystalline in form. In contrast, the amorphous film consisting of HPMC, PEG 6000 and excess CLP exhibited the crystallinity film by an excess addition of CLP. Although the crystalline film had many cracks, the amorphous film appeared to be excellent as a tablet coating. The most probable interaction sites between HPMC and CLP were demonstrated by FT-IR analysis of casting films consisting of HPMC, CLP and PVP.