Assessment of a five-layer laminate technique to measure the saturation solubility of drug in pressure-sensitive adhesive film.

Assessment of a five-layer laminate technique to measure the saturation solubility of drug in pressure-sensitive adhesive film.
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测量压敏粘合膜中药物饱和溶解度的五层层压技术的评估

DOI:
10.1002/jps.23156
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发表时间:
2012
影响因子:
3.8
通讯作者:
Geoffrey Lee
Geoffrey Lee
中科院分区:
医学3区
文献类型:
--
作者:
Simone Reismann;Geoffrey Lee

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五层层压技术用于确定药物在用于制备透皮贴剂的压敏粘合剂 (PSA) 聚合物薄膜中的饱和溶解度。负载药物的供体聚合物膜通过分离膜附着到最初不含药物的受体聚合物膜上。药物扩散到受体中直至达到饱和溶解度平衡。这项使用药物坦索罗辛和 PSA Duro Tak 87-4098 的系统研究是对扩散过程的动力学分析。研究发现,在供体中存在药物结晶相的情况下,该技术给出了 PSA 聚合物膜中 cps 的平衡值。高渗透性 Perthese 分离膜导致受体过冲,很可能是由供体的初始过饱和引起的。更换为渗透性较低的乙烯-醋酸乙烯酯分离膜避免了过度调节,但达到平衡的时间较长,> 300 天。使用 Perthese 预加载受体可将平衡过程加快至大约 50 天。确定了合适的实验条件,如果操作正确,该技术可以给出 cp s 的平衡值。© 2012 Wiley periodicals, Inc. 和美国药剂师协会
A five-layer laminate technique is used to determine the saturation solubility of a drug in a thin polymer film, c p s, of pressure-sensitive adhesive (PSA) used to prepare transdermal patches. A drug-loaded donor polymer film is attached via a separating membrane to an initially drug-free acceptor polymer film. Diffusion of drug occurs into the acceptor up to saturation solubility equilibrium. This systematic study of the technique using the drug tamsulosin and the PSA Duro Tak 87-4098 was a kinetic analysis of the diffusion process. It was found that the technique gives an equilibrium value for c p s in a PSA polymer film in the presence of crystalline phase of the drug in the donor. A highly permeable Perthese-separating membrane caused overshoot in the acceptor, most likely induced by initial supersaturation of the donor. Change to a less-permeable ethylene-vinyl-acetate-separating membrane avoided overshoot, but gave a prolonged time,> 300 days, to equilibrium. Preloading the acceptor accelerated the equilibration process to approximately 50 days with the Perthese. Suitable experimental conditions are identified that, if performed correctly, allow the technique to give an equilibrium value for c p s.© 2012 Wiley Periodicals, Inc. and the American Pharmacists Association
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