使用马来酸奈拉替尼无水替代结晶的口服固体制剂：制药、生物等效性和临床角度。

IF 1.8 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Biomedical Chromatography Pub Date : 2024-08-20 DOI:10.1002/bmc.5988

Congmei Ming, Zhi Liu, Qiong Wang, Ling Liu, Xiaokun Shen

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引用次数: 0

摘要

奈拉替尼（一种活性药物成分[API]）是一种不可逆的泛人类表皮生长因子受体（HER）抑制剂，用于治疗HER2阳性乳腺癌。其剂型（在美国、中国、欧洲和其他地区销售）为口服片剂，品牌产品（NERLYNX）的结晶型马来酸奈拉替尼一水合物已获得专利保护。本文介绍了使用稳定的无水结晶马来酸奈拉替尼进行的产品开发、稳定性研究、产品的生物等效性（BE）研究，并讨论了临床研究中观察到的不良反应。

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Oral solid dosage form using alternate crystalline neratinib maleate anhydrous form: Pharmaceutical, bioequivalent, and clinical perspectives.

Neratinib (an active pharmaceutical ingredient [API]) is an irreversible pan-human epidermal growth factor receptor (HER) inhibitor used to treat HER2-positive breast cancer. The dosage form (marketed in the United States, China, Europe, and other regions) is a tablet for oral administration, and the brand product (NERLYNX) has patent protection for the crystalline neratinib maleate monohydrate form. This paper describes the product development using stable crystalline neratinib maleate anhydrous form, stability study, bioequivalence (BE) study of the products, and discussion of the adverse effects observed in the clinical study.

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.