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Effects of process parameters on solid self-microemulsifying particles in a laboratory scale fluid bed.

Tusharmouli Mukherjee¹, Fotios M Plakogiannis

¹Division of Pharmaceutical Science, Arnold Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USA. tmouli@hotmail.com

Pharmaceutical Development and Technology

|February 3, 2011

Summary

This study identified key fluid bed process parameters affecting solid self-microemulsifying (SME) system quality for albendazole (ABZ). Increased spray rate and inlet air temperature significantly impacted particle size and moisture, enabling process optimization.

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Area of Science:

Pharmaceutical Technology
Chemical Engineering
Materials Science

Background:

Solid self-microemulsifying (SME) systems offer enhanced drug delivery.
Fluid bed processing is crucial for manufacturing SME systems.
Identifying critical process parameters (CPPs) is essential for robust manufacturing.

Purpose of the Study:

To determine critical process parameters (CPPs) in fluid bed processing for albendazole (ABZ) solid SME systems.
To establish a design space for optimizing the manufacturing process.
To understand the impact of process parameters on SME system quality attributes.

Main Methods:

A fractional factorial design (2(4-1)) was employed to study four parameters: spray rate, inlet air temperature, inlet air flow, and atomization air pressure.
Batches were manufactured using a laboratory top-spray fluid bed.
Quality attributes including loss on drying (LOD), particle size distribution (PSD), morphology, density, and flow were analyzed.

Main Results:

Increased spray rate correlated with increased Sauter-mean diameter (D(s)).
Inlet air temperature significantly affected peak moisture, directly influencing mean particle size.
Two-way interactions between parameters were observed; main effects of inlet air flow and atomization air pressure were inconclusive.
A partial least square (PLS) regression model proved significant and predictive for optimization.

Conclusions:

Critical process parameters for albendazole SME fluid bed manufacturing were identified.
A significant design space was established, enabling process optimization and control.
The study provides a foundation for scalable and reproducible manufacturing of albendazole SME systems.