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首页> 美国卫生研究院文献>AAPS PharmSciTech >Pharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochloride
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Pharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochloride

机译：一种新型盐酸氟喷特醇的快速溶解膜制剂的药物和药代动力学评价

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摘要

The objective of the present study was to develop fast dissolving oral film of the antipsychotic drug, flupentixol dihydrochloride, to enhance its bioavailability, optimize its therapeutic effect when used to treat depression with anxiety, and increase the convenience and compliance by the mentally ill, developmentally disable, elderly, and pediatric patients. Six formulae were prepared with different concentrations of water-soluble polymers vis. hydroxypropyl methylcellulose (HPMC E5) and carboxymethyl cellulose (CMC) by solvent casting technique. The prepared films were subjected to characterization for folding endurance, weight variations, thickness, disintegration time, drug release pattern, and drug content. Physical compatibility between the drug and excipients was guaranteed in the selected formulation (2% HPMC) by means of differential scanning calorimetry analysis and Fourier-transform infrared spectroscopy. This formulation revealed high stability after testing according to the International Conference on Harmonisation guidelines. In vivo studies based on single phase parallel design were carried out for the optimized formulation in healthy human volunteers. The concentration of flupentixol dihydrochloride in plasma samples was analyzed by a developed validated LC-MS/MS assay method and the pharmacokinetic parameters of the established formulation were compared with the commercially available oral tablets. Faster rate of absorption of flupentixol could be obtained from the oral film formulation and the relative bioavailability was found to be 151.06% compared to the marketed product.
机译：本研究的目的是开发快速溶解的抗精神病药盐酸氟喷特索的口服膜，以提高其生物利用度，优化其用于治疗焦虑症时的治疗效果，并增加精神病患者在发育上的便利性和依从性禁用，老年人和儿科患者。用不同浓度的水溶性聚合物制备了六个配方。羟丙基甲基纤维素（HPMC E5）和羧甲基纤维素（CMC）采用溶剂浇铸技术。对制得的膜进行耐折性，重量变化，厚度，崩解时间，药物释放模式和药物含量的表征。通过差示扫描量热分析和傅里叶变换红外光谱法，可以确保所选制剂（2％HPMC）中药物与赋形剂之间的物理相容性。根据国际协调会议指南进行测试后，该配方显示出很高的稳定性。基于单相平行设计的体内研究针对健康人类志愿者中的优化配方进行。通过开发的经过验证的LC-MS / MS分析方法分析血浆样品中盐酸氟喷特索的浓度，并将所建立制剂的药代动力学参数与市售口服片剂进行比较。从口服膜制剂中可以更快地吸收氟哌丁醇的吸收率，与市售产品相比，相对生物利用度为151.06％。

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