A Quality by Design (QbD) study in direct compression using the most flowable microcrystalline cellulose CEOLUS™ UF-702

OBJECTIVE

CEOLUS^TM UF-702 is the most flowable microcrystalline cellulose (MCC). While UF-702 has higher compactibility than standard grade PH-102, it has the lowest repose angle of known commercial grades of MCC. This is because the UF-702 particle has a round shape and has many pores inside its particle.

The purpose of this QbD study is to demonstrate that UF-702 has higher robustness compare to PH-102 by analyzing the impact of formulation and process variables on tablet’s critical quality attributes (CQAs) in direct compression of poorly compactible and flowing drug.

What is Ceolus^TM UF-702?

CEOLUS^TM UF-702 is an NF/EP/JP compatible MCC.

Powder properties

Tab.1 Powder properties of CEOLUS^TM grades:

Particle morphology

Fig.2 Particle morphology of CEOLUS^TM grades:

Fig.3 Relationship between compactibility and flowability of MCC grade:

METHOD

Formulation and Process variables

1) Drug Loading,      2) Lubricant level,    3) Tableting speed.

Asahi Kasei compared the robustness between UF-702 and PH-102 by measuring design space, where each hardness was over 110 N and weight RSD was below 1%.

RESULTS

with fixed APAP

UF-702 had wider design space than PH-102.

UF-702 has lower lubricant sensitivity than PH-102.

CONCLUSION

In case of CEOLUS^TM UF-702, formulation and process variables had less impact on tablet’s CQAs than PH-102.

This QbD study demonstrated that CEOLUS^TM UF-702 formulation has a higher robustness than PH-102 formulation in direct compression of low compactible and flow drug.

REFERENCE

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