Tablet Hardness, Friability, and Dissolution: Key Quality Parameters in Dietary Supplement Manufacturing

Tablets are one of the most widely used dosage forms in the dietary supplement industry due to their stability, scalability, and ease of handling. To ensure consistent product quality and regulatory compliance, manufacturers monitor several critical physical parameters during production. Among the most important are tablet hardness, friability, and dissolution.

For brand owners and distributors, understanding these parameters helps support informed decision-making when selecting a manufacturing partner such as CSK Biotech.

Overview of Tablet Quality Parameters

Tablet quality parameters describe physical and mechanical characteristics that affect manufacturing consistency, packaging performance, and product handling. These parameters are evaluated against predefined internal specifications and relevant pharmacopeial or industry guidelines, where applicable.

They do not imply or guarantee any functional or health-related outcomes.

Tablet Hardness

What Is Tablet Hardness?

Tablet hardness refers to the mechanical strength of a tablet, typically measured as the force required to break it under controlled conditions. Hardness is influenced by formulation composition, compression force, and tooling design.

Why Hardness Matters

Appropriate hardness helps tablets:

• Maintain structural integrity during handling and packaging

• Resist damage during transportation

• Maintain consistent appearance

Excessive hardness or insufficient hardness may affect downstream processing or handling, which is why hardness is carefully monitored during production.

Tablet Friability

What Is Friability?

Friability measures a tablet’s resistance to surface abrasion and chipping during handling. It is usually assessed by rotating tablets in a standardized testing device and measuring weight loss.

Importance of Friability Control

Low friability indicates that tablets can withstand:

• Bottling and packaging operations

• Transportation and routine handling

Friability testing supports quality consistency and helps reduce the risk of damaged or visually inconsistent tablets.

Tablet Dissolution

What Is Dissolution?

Dissolution testing evaluates the physical disintegration and dispersion behavior of a tablet under defined laboratory conditions. It is a controlled quality test used to assess batch-to-batch consistency.

In the dietary supplement context, dissolution testing is a quality control tool, not a measure of efficacy or physiological performance.

Factors Influencing Dissolution

Tablet dissolution characteristics may be influenced by:

• Tablet hardness and compression force

• Binder and excipient selection

• Tablet coating type

• Manufacturing process parameters

Balancing these factors is essential to maintain consistent tablet quality.

Relationship Between Hardness, Friability, and Dissolution

These three parameters are interconnected:

• Increasing compression force may improve hardness and reduce friability

• Excessive hardness may alter dissolution behavior

• Inadequate hardness may lead to higher friability

Manufacturers must optimize formulations and processes to achieve balanced and reproducible results.

Quality Control Practices at CSK Biotech

At CSK Biotech, tablet manufacturing is supported by:

• GMP-compliant production environments

• In-process monitoring of compression parameters

• Defined specifications for hardness and friability

• Routine quality checks to ensure batch consistency

These practices help support reliable tablet production across a wide range of formulations and formats.

Regulatory Considerations for Global Markets

Tablet quality testing must align with applicable regulatory frameworks, including:

• US FDA dietary supplement manufacturing requirements

• EU food supplement regulations

• Germany’s LFGB standards

• Relevant Chinese food and health product quality requirements

All testing results and specifications must be documented and presented accurately without misleading statements.

Conclusion

Tablet hardness, friability, and dissolution are essential physical quality parameters in dietary supplement manufacturing. Proper control of these characteristics supports consistent production, efficient packaging, and regulatory compliance across global markets.

By working with an experienced contract manufacturer such as CSK Biotech, brands can develop tablet products that meet defined quality standards while remaining fully compliant with international regulations.