硫酸阿巴卡韦粘合剂口腔黏膜的开发和体内评估

Q2 Pharmacology, Toxicology and Pharmaceutics International Journal of Applied Pharmaceutics Pub Date : 2024-01-07 DOI:10.22159/ijap.2024v16i1.49765
M. P., R. G. V.
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引用次数: 0

摘要

研究目的本研究旨在评估硫酸阿巴卡韦粘合剂口腔黏膜的体内药代动力学参数:方法:采用溶剂浇注法制备硫酸阿巴卡韦黏附性口腔黏膜,并对制备的口腔黏膜进行定性和定量参数评估。使用健康的白化白兔对药代动力学参数(最大血浆浓度[Cmax]、最大血浆浓度[Tmax]、曲线下面积[AUC]和生物半衰期[t1/2])进行了体内评价。对采集的血样进行了评估,并将结果与参考标准 Ziagen 进行了比较。统计研究使用了 Modern Version 6 软件和药代动力学函数(Microsoft Excel add-in)应用程序:结果:成功制备了硫酸阿巴卡韦粘合剂口腔胶片,评估的定性和定量参数均在可接受范围内。研究结果表明,硫酸阿巴卡韦粘合剂口腔黏膜的 Cmax、Tmax、AUC0-t、AUC0-α 和 t1/2 分别为 93.86 ng/ml、8 h、1652.21 ng/ml×h、2939.76 ng/ml×h 和 17.96 h。这些结果与参考标准相当:结论:在相同剂量下,试验制剂中硫酸阿巴卡韦的总体吸收率高于标准品。因此,该研究得出结论,与传统制剂相比,硫酸阿巴卡韦粘液黏附性口腔胶片的粘附时间更长,生物利用度更高。
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DEVELOPMENT AND IN VIVO EVALUATION OF ABACAVIR SULPHATE MUCOADHESIVE BUCCAL FILMS
Objective: The objective of the study was to evaluate the pharmacokinetic parameters of abacavir sulphate mucoadhesive buccal films in vivo. Methods: Abacavir sulphate mucoadhesive buccal films were developed using the solvent casting method and the prepared buccal films were evaluated for qualitative and quantitative parameters. Pharmacokinetic parameters (maximum plasma concentration [Cmax], maximum plasma concentration [Tmax], area under the curve [AUC], and biological half-life [t1/2]) were evaluated in vivo using healthy albino white rabbits. The blood samples were collected evaluated and the results were compared with Ziagen a reference standard. The Modern Version 6 software and the pharmacokinetic function (Microsoft Excel add-in) applications were used to conduct the statistical study. Results: The abacavir sulphate mucoadhesive buccal films were prepared successfully and the evaluated qualitative and quantitative parameters were within in the acceptable range. The results of the study stated that Cmax, Tmax, AUC0-t, AUC0-α, and t1/2 of abacavir sulphate mucoadhesive buccal film were found to be 93.86 ng/ml, 8 h, 1652.21 ng/ml×h, 2939.76 ng/ml×h, and 17.96 h, respectively. These results were comparable with the reference standard. Conclusion: The overall absorption of abacavir sulphate was more in the test formulation with respect to the reference product at the same dose. Hence the study concludes that abacavir sulphate mucoadhesive buccal films achieved prolonged muchoadhesion and improved bioavailability compared to the conventional formulation.
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来源期刊
International Journal of Applied Pharmaceutics
International Journal of Applied Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
CiteScore
1.40
自引率
0.00%
发文量
219
期刊介绍: International Journal of Applied Pharmaceutics (Int J App Pharm) is a peer-reviewed, bimonthly (onward March 2017) open access journal devoted to the excellence and research in the pure pharmaceutics. This Journal publishes original research work that contributes significantly to further the scientific knowledge in conventional dosage forms, formulation development and characterization, controlled and novel drug delivery, biopharmaceutics, pharmacokinetics, molecular drug design, polymer-based drug delivery, nanotechnology, nanocarrier based drug delivery, novel routes and modes of delivery; responsive delivery systems, prodrug design, development and characterization of the targeted drug delivery systems, ligand carrier interactions etc. However, the other areas which are related to the pharmaceutics are also entertained includes physical pharmacy and API (active pharmaceutical ingredients) analysis. The Journal publishes original research work either as a Original Article or as a Short Communication. Review Articles on a current topic in the said fields are also considered for publication in the Journal.
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