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首页> 美国卫生研究院文献>AAPS PharmSciTech >Development and Characterization of Mucoadhesive In Situ Nasal Gel of Midazolam Prepared with Ficus carica Mucilage
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Development and Characterization of Mucoadhesive In Situ Nasal Gel of Midazolam Prepared with Ficus carica Mucilage

机译：榕树黏液制备咪达唑仑粘膜黏着剂鼻用凝胶的研制与表征

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The objective of the present study was to prepare mucoadhesive in situ nasal gels with mucilage isolated from fig fruits (Ficus carica, family: Moraceae) containing midazolam hydrochloride. Nasal gels of midazolam were prepared using three different concentrations (0.5%, 1.0% and 1.5% w/v) of F. carica mucilage (FCM) and synthetic polymers (hydroxypropylmethyl cellulose and Carbopol 934). Evaluation of FCM showed that it was as safe as the synthetic polymers for nasal administration. In situ gels were prepared with mixture Pluronic F127 and mucoadhesive agents. Evaluation of the prepared gels was carried out, including determination of viscosity, texture profile analysis and mucoadhesive strength. In vitro drug permeation study was conducted with the gels prepared with and without permeation enhancer (0.5% w/v sodium taurocholate) using excised goat nasal mucosa. In vitro permeation profiles were evaluated, and histological study of nasal mucosae before and after permeation study was also conducted to determine histological change, if any. In vivo experiments conducted in rabbits further confirmed that in situ nasal gels provided better bioavailability of midazolam than the gels prepared from synthetic mucoadhesive polymers. It was observed that the nasal gel containing 0.5% FCM and 0.5% sodium taurocholate exhibited appropriate rheological, mechanical and mucoadhesive properties and showed better drug release profiles. Moreover, this formulation produced no damage to the nasal mucosa that was used for the permeation study, and absolute bioavailability was also higher compared to gels prepared from synthetic polymers.
机译：本研究的目的是制备具有粘胶的原位鼻腔凝胶，其凝胶是从含有咪达唑仑盐酸盐的无花果果实（无花果，家族：桑科）中分离得到的。使用三种不同浓度（0.5％，1.0％和1.5％w / v）的F. Carica mucilage（FCM）和合成聚合物（羟丙基甲基纤维素和Carbopol 934）制备咪达唑仑的鼻凝胶。对FCM的评估表明，与经鼻给药的合成聚合物一样安全。用Pluronic F127和粘膜粘附剂的混合物制备原位凝胶。对所制备的凝胶进行评估，包括确定粘度，质地分布分析和粘膜粘附强度。使用切除的山羊鼻粘膜，对有或没有渗透促进剂（0.5％w / v牛磺胆酸钠）制备的凝胶进行体外药物渗透研究。评价了体外渗透概况，并且还进行了渗透研究之前和之后鼻粘膜的组织学研究，以确定是否有组织学变化。在兔子中进行的体内实验进一步证实，与从合成粘膜粘附性聚合物制备的凝胶相比，原位鼻腔凝胶可提供咪达唑仑更好的生物利用度。观察到，包含0.5％FCM和0.5％牛磺胆酸钠的鼻凝胶显示出适当的流变，机械和粘膜粘附特性​​，并显示出更好的药物释放曲线。而且，该制剂不会对用于渗透研究的鼻粘膜产生损伤，并且与由合成聚合物制备的凝胶相比，绝对生物利用度也更高。

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