药学实践中艾多沙班片剂重量变化及溶出度的研究

Q4 Pharmacology, Toxicology and Pharmaceutics Pharmaceutical Sciences Asia Pub Date : 2022-01-01 DOI:10.29090/psa.2022.02.21.133
M. Nimworapan, Sinwisuth Sutheechai, W. Wongcharoen, A. Phrommintikul, S. Eakanunkul
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引用次数: 0

摘要

依多沙班有60mg、30mg和15mg无刻痕薄膜包衣片剂。片剂拆分可能是降低药物成本和减少国家预算的一种选择。本研究的目的是测定60 mg艾多沙班半片剂的重量变化和溶出度。30片60毫克的依多沙班被一名右撇子药剂师切成两半。比较了整片和半片的重量变化情况。溶出度试验采用3种溶出介质分别溶出6片整片和12片半片。60半片依多沙班的预期半片重量在美国药典(USP)的75% - 125%范围内。第1、2半片剂的平均总重量与完整片剂的平均总重量无显著差异(p值=0.216)。在0.1 N HCl介质中,15 min内整片和半片的释药量均大于85%,符合溶出度试验验收标准。艾多沙班片剂分裂后重量变化较小。因此,依多沙班片剂可以用片剂切割器切成两半。
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Study of weight variation and dissolution of Edoxaban split tablets in pharmacy practice
Edoxaban is available in 60 mg, 30 mg, and 15 mg unscored film-coated tablets. Tablet splitting may be an option to reduce medication costs and reduce the country’s budget. The objectives of this study were to determine the weight variation and the dissolution profile of the 60 mg edoxaban in split half-tablets using a pill splitter. Thirty edoxaban 60 mg tablets were cut into halves by a right-handed pharmacist. The weight variation of the whole and half tablets were compared. For the dissolution test, 6 whole tablets and 12 half-tablets were separately dissolved in three dissolution media. Sixty half-tablets of edoxaban had the expected half-tablet weight within the 75% to 125% range that fell within the proxy United States Pharmacopeia (USP). The mean total weight of the 1 st and 2 nd halves were not significantly different from the mean weight of the intact tablets ( p -value=0.216). The amount of drug release from the whole and half tablets in 0.1 N HCl medium was greater than 85% in 15 minutes which met the acceptance criteria for the dissolution test. Edoxaban tablets splitting had low variations in weight. Therefore, edoxaban tablets can be split into halves by a tablet cutter.
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来源期刊
Pharmaceutical Sciences Asia
Pharmaceutical Sciences Asia Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
0.90
自引率
0.00%
发文量
59
期刊介绍: The Pharmaceutical Sciences Asia (PSA) journal is a double-blinded peer-reviewed journal in English published quarterly, by the Faculty of Pharmacy, Mahidol University, Thailand. The PSA journal is formerly known as Mahidol University Journal of Pharmaceutical Sciences and committed to the timely publication of innovative articles and reviews. This journal is available in both printed and electronic formats. The PSA journal aims at establishing a publishing house that is open to all. It aims to disseminate knowledge; provide a learned reference in the field; and establish channels of communication between academic and research expert, policy makers and executives in industry and investment institutions. The journal publishes research articles, review articles, and scientific commentaries on all aspects of the pharmaceutical sciences and multidisciplinary field in health professions and medicine. More specifically, the journal publishes research on all areas of pharmaceutical sciences and related disciplines: Clinical Pharmacy Drug Synthesis and Discovery Targeted-Drug Delivery Pharmaceutics Biopharmaceutical Sciences Phytopharmaceutical Sciences Pharmacology and Toxicology Pharmaceutical Chemistry Nutraceuticals and Functional Foods Natural Products Social, Economic, and Administrative Pharmacy Clinical Drug Evaluation and Drug Policy Making Antimicrobials, Resistance and Infection Control Pharmacokinetics and Pharmacodynamics.
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