Method to study the effect of blend flowability on the homogeneity of acetaminophen

Abstract

Context: Excipient selection is key to product development because it affects their processability and physical properties, which ultimately affect the quality attributes of the pharmaceutical product.

Objective: To study how the flowability of lubricated formulations affects acetaminophen (APAP) homogeneity.

Materials and methods: The formulations studied here contain one of two types of cellulose (Avicel 102 or Ceollus KG-802), one of three grades of Mallinckrodt APAP (fine, semi-fine, or micronized), lactose (Fast-Flo) and magnesium stearate. These components are mixed in a 300-liter bin blender. Blend flowability is assessed with the Gravitational Displacement Rheometer. APAP homogeneity is assessed with off-line NIR.

Results: Excluding blends dominated by segregation, there is a trend between APAP homogeneity and blend flow index. Blend flowability is affected by the type of microcrystalline cellulose and by the APAP grade.

Conclusion: The preliminary results suggest that the methodology used in this paper is adequate to study of the effect of blend flow index on APAP homogeneity.

Keywords:

• Blend homogeneity
• powder flow
• microcrystalline cellulose
• acetaminophen
• shear mixing