Main causes of unqualified tablet hardness?

Main causes of unqualified tablet hardness?

I. Core Process Factors

‌Insufficient Compression Force‌

Directly leads to weak bonding between particles and is the primary cause of hardness failure.

Can be optimized by adjusting tablet press parameters or increasing pre-compression pressure.

‌Binder Issues‌

‌Insufficient Dosage‌: Weak adhesion between particles, affecting tablet formation.

‌Excessive Amount‌: May cause abnormal hardness increase (e.g., overly hard) but does not align with the "failure" scenario described in the question.

‌Insufficient Lubricant‌

Affects ejection efficiency, indirectly increasing compression force requirements but having minimal direct impact on hardness.

II. Raw Material and Excipient Factors

‌Uneven Particle Size‌: Affects compression uniformity, leading to localized hardness insufficiency.

‌Excessive Disintegrant‌: Primarily affects disintegration but may weaken interparticle bonding when overused.

III. Other Factors

‌Improper Moisture Control‌: Inadequate moisture increases particle brittleness, while excessive moisture may cause sticking.

‌Improper Equipment Adjustment‌: Such as tablet press tool wear or excessive speed.

Recommended Solutions

Prioritize checking compression force parameters to ensure compliance with process requirements.

Optimize binder ratio to balance adhesion and disintegration.

Examine particle flowability and uniformity, and re-granulate if necessary.

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