Chopra Ranjana, Alderborn Göran, Newton J Michael, Podczeck Fridrun
Department of Pharmaceutics, School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK.
Pharm Dev Technol. 2002 Jan;7(1):59-68. doi: 10.1081/pdt-120002231.
There are numerous reasons for which film coatings are applied to pellet formulations; for example, controlled release, taste masking, and improved stability. The aim of this paper was to study the influence of pellet shape on the deposition of film coatings in a fluid-bed process by monitoring the pellet shape as a function of the film thickness formed. Eight pellet batches were used, of which four were spherical visually, and the other batches can be described as ovoids, dumbbells, long dumbbells, and cylinders. The average coat thickness of the pellets assessed by cross-section measurements did not appear to be influenced by the initial shape of the pellets. The fluid-bed process, however, had an impact especially for those pellets that had an aspect ratio greater than 1.5. The change in the pellet shape during film coating could only be monitored effectively employing a three-dimensional shape factor. Significant changes in shape occurred at the beginning of the coating process up to approximately the first 15 min, after which the shape remained constant.
将薄膜包衣应用于微丸制剂有诸多原因;例如,控释、掩味和提高稳定性。本文的目的是通过监测微丸形状随所形成薄膜厚度的变化,研究微丸形状对流化床工艺中薄膜包衣沉积的影响。使用了八批微丸,其中四批在视觉上呈球形,其他批次可描述为卵形、哑铃形、长哑铃形和圆柱形。通过横截面测量评估的微丸平均包衣厚度似乎不受微丸初始形状的影响。然而,流化床工艺尤其对那些长径比大于1.5的微丸有影响。薄膜包衣过程中微丸形状的变化只能通过三维形状因子有效地监测。在包衣过程开始至大约前15分钟期间,形状发生了显著变化,之后形状保持不变。