Evaluation of coat uniformity and taste-masking efficiency of irregular-shaped drug particles coated in a modified tangential spray fluidized bed processor

Abstract

Objective: To explore the feasibility of coating irregular-shaped drug particles in a modified tangential spray fluidized bed processor (FS processor) and evaluate the coated particles for their coat uniformity and taste-masking efficiency.

Methods: Paracetamol particles were coated to 20%, w/w weight gain using a taste-masking polymer insoluble in neutral and basic pH but soluble in acidic pH. In-process samples (5, 10 and 15%, w/w coat) and the resultant coated particles (20%, w/w coat) were collected to monitor the changes in their physicochemical attributes.

Results: After coating to 20%, w/w coat weight gain, the usable yield was 81% with minimal agglomeration (< 5%). Some aerodynamic modifications to particle shape and surface morphology were observed for the in-process samples with 5 and 10% coat compared with the uncoated particles. A 15%, w/w coat was optimal for inhibiting drug release in salivary pH with subsequent fast dissolution in simulated gastric pH.

Conclusion: The FS processor shows promise for direct coating of irregular-shaped drug particles with wide size distribution. The coated particles with 15% coat were sufficiently taste masked and could be useful for further application in orally disintegrating tablet platforms.

Keywords:

• coat uniformity
• coating
• drug particles
• fluidized bed
• swirling airflow
• taste masking

Acknowledgments

Appreciation to BASF for the generous supply of the Kollicoat® Smartseal 30D used for taste masking.

Declaration of interest

The authors would like to acknowledge financial support from GEA-NUS PPRL fund (N-148-000-008-001) and A*STAR SERC Grant No. 102 161 0049 (R-148-000-157-305). M Xu is a recipient of the National University of Singapore Graduate Research Scholarship. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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