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Hadi Valizadeh,Parvin Zakeri-Milani,Peyman Nayyeri-Maleki,Saeed Ghanbarzadeh,Ahad Sheikhloo,Hossein Servat,Mahboob Nemati 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.1
The aim of this study was to evaluate thepharmacokinetics (PK) and bioequivalence (BE) of twometformin tablets. For in vitro evaluation, weight variation,assay and dissolution tests were performed. A randomized,single dose, two-period, cross over study in healthy malefasting volunteers was designed. A 2-week washout periodseparated the two periods. For analysis of PK parametersblood sampling was performed before and after drugadministration in various time points up to 12 h. Metforminconcentration in plasma was determined using a developedhigh performance liquid chromatography method. Bothformulations passed the assay, content uniformity, and dissolutiontests acceptance value. PK parameters, representingthe rate and the extent of metformin absorption were calculatedand analyzed for two formulations. The 90 % CIobtained by analysis of variance for the ratios of Cmax,AUC0–t, and AUC0–? were 92.14–110.95, 92.72–107.37and 89.42–110.23 % respectively, meeting the criteria forBE (80–125 %). Administration of a single dose of test andreference formulations did not result in statistically significantdifferences between in vitro and in vivo BE parametersin healthy Iranian male volunteers. Thus in the case of rateand extent of absorption the test and reference formulationswere considered bioequivalent.
Synthesis, Characterization and in vitro Anti-Tumoral Evaluation of Erlotinib-PCEC Nanoparticles
Barghi, Leila,Asgari, Davoud,Barar, Jaleh,Nakhlband, Aylar,Valizadeh, Hadi Asian Pacific Journal of Cancer Prevention 2014 Asian Pacific journal of cancer prevention Vol.15 No.23
Background: Development of a nanosized polymeric delivery system for erlotinib was the main objective of this research. Materials and Methods: Poly caprolactone-polyethylene glycol-polycaprolactone (PCEC) copolymers with different compositions were synthesized via ring opening polymerization. Formation of triblock copolymers was confirmed by HNMR as well as FT-IR. Erlotinib loaded nanoparticles were prepared by means of synthesized copolymers with solvent displacement method. Results: Physicochemical properties of obtained polymeric nanoparticles were dependent on composition of used copolymers. Size of particles was decreased with decreasing the PCL/PEG molar ratio in used copolymers. Encapsulation efficiency of prepared formulations was declined by decreasing their particle size. Drug release behavior from the prepared nanoparticles exhibited a sustained pattern without a burst release. From the release profiles, it can be found that erlotinib release rate from polymeric nanoparticles is decreased by increase of CL/PEG molar ratio of prepared block copolymers. Based on MTT assay results, cell growth inhibition of erlotinib has a dose and time dependent pattern. After 72 hours of exposure, the 50% inhibitory concentration (IC50) of erlotinib hydrochloride was appeared to be $14.8{\mu}M$. Conclusions: From the obtained results, it can be concluded that the prepared PCEC nanoparticles in this study might have the potential to be considered as delivery system for erlotinib.