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首页> 外文期刊>Journal of drug targeting >Formulation and evaluation of anti-rheumatic dexibuprofen transdermal patches: a quality-by-design approach
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Formulation and evaluation of anti-rheumatic dexibuprofen transdermal patches: a quality-by-design approach

机译：抗风湿性Dexibuprofen透皮贴剂的制剂和评价：一种质量逐设计方法

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摘要

Dexibuprofen (DXIBN) transdermal patches were formulated using various concentrations of selected polymeric excipients (matrix material; ethyl cellulose and polyvinylpyrrolidone, plasticizer (di-N-butyl phthalate), and a conventional permeation enhancer (almond oil)). Initial patch formulations were evaluated for their physiochemical properties (thickness, moisture uptake, final moisture content, and DXIBN content). Also, impact of patch components on resulting tensile strength and in vitro permeation were used to predict an optimal patch formulation using a quality-by-design (QbD) approach, which was subsequently evaluated and further compared with a commercial oral tablet dosage form for in vitro and in vivo release (rabbit model). Initially formulated patches demonstrated uniform thickness (0.44 +/- 0.02 cm), relatively low moisture uptake (7.87 +/- 1.11 w/w %), and highly acceptable drug loading values (100.0 +/- 0.026%). The tensile strength of patches increased significantly with matrix polymer concentration and to a lesser degree with increase in plasticizer and permeation enhancer content, although these affected the permeation of DXIBN. Predicted properties (tensile strength and DXIBN steady-state flux) for the QbD-optimized formulation were in close agreement to experimental results. The QbD optimal patch formulation behavior differed significantly from the commercial tablet formulation in vivo. Such model-based predictions (QbD approach) will reduce cost and time in formulation development sciences.
机译：使用各种浓度的选定的聚合物赋形剂（基质材料;乙基纤维素和聚乙烯吡咯烷酮，增塑剂（邻苯二甲酸二丁酯）和常规渗透增强剂（杏仁油））配制Dexibuprofen贴剂。评估初始贴剂制剂的其生理化学性质（厚度，湿度吸收，最终水分含量和DXIBN含量）。此外，使用贴剂组分对产生的拉伸强度和体外渗透的影响来预测使用质量 - 逐项（QBD）方法的最佳贴剂配方，随后评估并进一步与商业口服片剂剂型相比体外和体内释放（兔模型）。最初配制的贴剂显示均匀的厚度（0.44 +/- 0.02cm），含水量相对低（7.87 +/- 1.11w / w％），高度可接受的药物负载值（100.0 +/- 0.026％）。斑块的拉伸强度随着基质聚合物浓度显着增加，并随着增塑剂和渗透增强剂含量的增加而较小程度增加，尽管这些影响了DXIBN的渗透性。 QBD优化配方的预测性质（拉伸强度和DXIBN稳态通量）与实验结果密切一致。 QBD最佳补丁配方行为与体内商业片剂配方有显着不同。基于模型的预测（QBD方法）将降低配方开发科学中的成本和时间。

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