Fast dissolving sublingual films of methylphenidate hydrochloride for cancer-related fatigue management:Formulation and in vitro/in vivo evaluation
Objective: The purpose of this study was to formulate Methylphenidate hydrochloride (MPH) as oral fast dissolving sublingual films (OFDSFs) in a trial to improve its bioavailability and patient compliance.Methods: The MPH-OFDSFs were prepared by casting method and evaluated for their film thickness, mechanical properties, in vitro disintegration and release.The content uniformity and stability were also tested.To verify the advantages of the OFDSFs, the pharmacokinetic properties were investigated and compared with oral solution of MPH.Results: The prepared MPH-OFDSFs showed desired mechanical properties and film thickness.The drug content of MPH-OFDSFs was within 85%-115%.The films were found to be stable for 4 months when stored at 40℃ and 75% RH.In vitro release studies suggested a rapid disintegration, in which most of MPH was released 99.00 ± 0.49% of drug within 3 min.The absorption of MPH from sublingual administration of MPH films in rats resulted in 4.57-fold increased in bioavailability as compared to oral administration of pure drug solution.Conclusion: These results suggest that the fast dissolving sublingual film containing MPH is likely to become one of the choices for treatment of cancer-related fatigue (CRF).
Methylphenidate hydrochloride Fast dissolving film Sublingual films Cancer-related fatigue Pharmacokinetics
Cheng-ying Shen Li-hong Zhang Bao-de Shen Ping-hua Xu Na Wu Juan Zheng Hai-long Yuan
Department of Pharmacy, Air Force General Hospital of PLA, Beijing 100142, China Department of Pharmacy, Air Force General Hospital of PLA, Beijing 100142, China;Jiangxi University
国内会议
南昌
英文
449-457
2016-09-27（万方平台首次上网日期，不代表论文的发表时间）