数据日期 2026-10-29 · 生成时间 2026-10-29 06:03
研究问题
Metformin hydrochloride remains the gold-standard first-line therapy for managing type 2 diabetes mellitus due to its established efficacy, favorable safety profile, and extensive clinical utility [1,2].
方法
Particle size distribution was determined by sieve analysis using a Robot Sifter (Model RPS-01, Seishin Enterprise Co., Ltd., Tokyo, Japan) fitted with a sieve stack of 850, 500, 355, 250, 180, and 106 µm, operated at a vibration level of 70 and a frequency of 65 Hz, with a pulse interval of 1 s and a total sieving time of 5 min.；The median particle diameter (D50) and the fine-particle fraction (percentage of granules passing through the 106 µm sieve relative to the total granule mass) were recorded in duplicate (n = 2) for each batch.；Tablet Thickness: The thickness of the core tablets was measured using a digital thickness tester (n = 10) immediately after compression, to assess dimensional consistency across the tested compression force and tableting speed conditions.；Samples were withdrawn at 45 min and quantified by UV-Vis spectrophotometry (Shimadzu Corporation, Kyoto, Japan) at 232 nm, using six tablets (n = 6) per tested condition; the acceptance criterion applied was ≥70% (Q) drug release at 45 min, consistent with the dissolution requirement specified in the USP monograph…
核心结论
At a constant chopper speed of 1400 rpm, extending the wet massing time from 3 to 7 min prompted a progressive and significant reduction in the compressibility index (CI) from 18.29% to 11.88%, signaling a substantial improvement in granule flowability.；The lowest CI value (11.88%), reflecting superior flow characteristics, was achieved at the 7 min threshold.；In contrast, granules produced at 2800 rpm exhibited minimal variations in bulk density, tapped density, and compressibility index (CI: 17.31–18.89%) across all mixing times. ‖ 结论：This study empirically examined the impact of manufacturing parameters across the wet granulation, compaction, and film-coating stages on the quality attributes of high-dose (1000 mg) metformin hydrochloride film-coated tablets, using a single-variable optimization approach.
局限
Conversely, excessive mechanical energy input triggers granule attrition and heightened heterogeneity—a phenomenon widely documented in granulation science where aggressive processing disrupts granule size distribution and flowability [42].
对本项目的价值
★★★☆☆ 代谢轴既干预敏感性最高，也是老药新用供给最充足的来源。最大样本量约 10；设计 定性研究。
全文来源
PMC JATS 全文（正文 63,084 字符，已过标题/DOI 逐字归属校验）
原文题录
- 英文标题：Impact of Process Parameters on the Quality Attributes of High-Dose Metformin Hydrochloride Film-Coated Tablets.
- 期刊与标识：Pharmaceutics · PMID 42942796 · DOI 10.3390/pharmaceutics18101264**
B 级证据分级：B 级（同行评议临床前研究，主要为动物模型）
本文核心结论来自动物模型或体外细胞学，属临床前证据，不能外推至人体。「延长健康寿命」「改善功能」等表述在小鼠中的意义，与人类临床结局之间仍有距离。
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