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Method to study the effect of blend flowability on the homogeneity of acetaminophen
Marcos Llusá1, Kalyana Pingali, Fernando J Muzzio
1Research Center Pharmaceutical Engineering GmbH, Graz, Austria. marcosllusa@yahoo.com
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.
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