行业组件数据 · 2026

填充剂/稀释剂

Inert substances added to pharmaceutical tablets to increase bulk, improve flow properties, and facilitate manufacturing.

技术定义与适配语境
典型 填充剂/稀释剂 会按材料、尺寸公差、适配关系和失效风险在 化学制造 中评估。

Filler/diluents are pharmacologically inactive excipients used in tablet formulation to provide adequate volume for compression, enhance powder flow during processing, and ensure uniform distribution of active pharmaceutical ingredients (APIs). They serve as bulking agents when API dosage is small, improving tablet weight consistency and mechanical strength while maintaining dissolution characteristics.

组件规格

定义
Filler/diluents are pharmacologically inactive excipients used in tablet formulation to provide adequate volume for compression, enhance powder flow during processing, and ensure uniform distribution of active pharmaceutical ingredients (APIs). They serve as bulking agents when API dosage is small, improving tablet weight consistency and mechanical strength while maintaining dissolution characteristics.
工作原理
Filler/diluents function by occupying space in tablet formulations, creating a compressible matrix that binds APIs and other excipients. They absorb compression forces during tableting, distribute stress evenly, and provide structural integrity through particle bonding mechanisms (mechanical interlocking, plastic deformation, or solid bridges). Their particle size distribution and morphology influence flowability, segregation resistance, and compaction behavior.
材料
Common materials include microcrystalline cellulose (MCC)lactose monohydratedicalcium phosphatemannitolstarch derivatives (pregelatinized starch)and calcium carbonate. Specifications typically cover particle size distribution (D10/D50/D90)bulk/tapped densitymoisture content (<5%)compressibility index (<20%)and microbial limits (<1000 CFU/g).
pH Range
5.0-8.0
Bulk Density
0.3-0.8 g/cm³
Particle Size
10-200 μm
Loss on Drying
<2%
Moisture Content
<5%
Compressibility Index
<20%
标准
ISO 9001ISO 13485USP-NFEPJP

行业分类与别名

填充剂/稀释剂 的常用贸易名称、技术标识和检索关键词。

上级产品

该组件会出现在以下整机或工业产品中。

FMEA · 风险与缓解

诱因 → 失效模式 → 工程缓解

Inadequate particle size distribution->Segregation during blending, resulting in content uniformity issues->Implement sieve analysis and optimize particle size matching with APIs
High moisture content in hygroscopic fillers->Reduced tablet hardness and chemical instability->Control storage humidity and use moisture-barrier packaging

工业生态与工程逻辑

0
Segregation due to particle size mismatch
1
Moisture absorption affecting stability
2
Incompatibility with APIs causing degradation
3
Poor flow leading to weight variation

合规与检测

tolerance
Weight variation ±5% for tablets >250mg, content uniformity RSD ≤6%
test method
USP <1217> for powder flow, USP <701> for disintegration, HPLC for assay uniformity

制造该组件的工厂

来自 CNFX 组件能力表的相关制造商资料。

制造商列表用于前期研究和供应商能力理解,不代表认证、排名或交易担保。

采购评估维度

不是客户评论,也不是实时热度。以下维度用于前期 RFQ 准备和供应商评估。

技术文档
4/5
制造能力
4/5
可检验性
5/5
供应商透明度
3/5

这些分值是采购评估维度示例,不代表真实客户评分、具体国家买家反馈或实时询盘。

相关组件

常见问题

What is the difference between filler and diluent in tablets?

While often used interchangeably, fillers primarily add bulk to achieve practical tablet size, whereas diluents specifically reduce API concentration to ensure accurate dosing. Both serve overlapping functions in flow enhancement and compression.

How do filler properties affect tablet dissolution?

Hydrophilic fillers like lactose accelerate dissolution by promoting water penetration, while hydrophobic materials may slow it. Particle size and solubility also influence disintegration rates and bioavailability.

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CNFX Industrial Component Index · 化学制造

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初步技术归类
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