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Fast dispersible/slow releasing ibuprofen tablets.

机译:快速分散/缓释布洛芬片剂。

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摘要

Eight formulations were developed containing ibuprofen in the form of orally disintegrating tablets. To prevent bitter taste and side effects of the drug, the drug was associated with Phospholipon 80H, a saturated lecithin, by wet granulation. The granules were then coated using different film forming agents (Kollicoat SR 30, Amprac 01, Kollidon 90F, Eudragit RD 100) obtaining four lots 1-4. Coated granules were then formulated with a sweetener (Aspartame), a mannitol-based diluent (Pearlitol SD 200) and Kollidon CL (1-4K) or Explotab (1-4E) were added as superdisintegrants and compacted under low compression force. The eight lots of tablets, 1-4K and 1-4E, were assessed if suitable as oral disintegrating tablets by determination of a range of technological parameters. Wetting and disintegregation time matched with the requirements of EP IV Ed., for almost all these formulations. Dissolution profiles suggested that the combined action of the hydrophobic lecithin and the coating delay the release of thedrug from tablets with respect to when it is free or in the form of simple granules. By an appropriate combination of excipients it was thus possible to obtain orally disintegrating tablets and a delayed release of ibuprofen using simple and conventional techniques.
机译:开发了八种包含布洛芬的口服崩解片剂形式的制剂。为了防止该药物的苦味和副作用,该药物通过湿法制粒与饱和卵磷脂磷脂80H结合。然后使用不同的成膜剂(Kollicoat SR 30,Amprac 01,Kollidon 90F,Eudragit RD 100)包衣颗粒,得到四个批次1-4。然后将包衣的颗粒与甜味剂(阿斯巴甜)一起配制,添加基于甘露醇的稀释剂(Pearlitol SD 200)和Kollidon CL(1-4K)或Explotab(1-4E)作为超级崩解剂,并在低压力下压实。通过确定一系列技术参数,评估八批片剂1-4K和1-4E是否适合作为口腔崩解片剂。几乎所有这些配方的润湿和分解时间均符合EP IV Ed。的要求。溶出曲线表明疏水卵磷脂和包衣的联合作用相对于药物的游离时间或以简单颗粒的形式延迟了药物从片剂的释放。通过赋形剂的适当组合,可以使用简单的常规技术获得口腔崩解片和布洛芬的延迟释放。

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