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Modeling powder encapsulation in dosator-based machines: II. Experimental evaluation.

Ammar Khawam¹, Leon Schultz

¹Department of Pharmaceutics, Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA. ammar.khawam@boehringer-ingelheim.com

International Journal of Pharmaceutics

|November 22, 2011

Summary

A new model accurately predicts powder encapsulation in dosator machines, validated with diverse powder types. This tool aids capsule development using quality by design (QbD) principles.

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Area of Science:

Pharmaceutical technology
Chemical engineering
Dosage form design

Background:

A theoretical model for powder encapsulation in dosator-based machines was previously developed.
This study focuses on the experimental evaluation of the previously derived theoretical model.

Purpose of the Study:

To experimentally validate a theoretical model for predicting powder encapsulation in dosator-based pharmaceutical machines.
To assess the model's efficacy with formulations exhibiting distinct flow properties.
To demonstrate the model's utility in capsule dosage form development adhering to Quality by Design (QbD) principles.

Main Methods:

Experimental evaluation of the theoretical model using two powder formulations with different flow characteristics.
Performing encapsulation experiments utilizing a Zanasi encapsulation machine under varied conditions.
Comparing model-predicted outcomes (fill weight, plug height) with experimentally obtained data.

Main Results:

A high correlation was observed between the model's predicted outcomes and experimentally obtained results.
The model successfully predicted encapsulation parameters for both powder formulations.
Validation confirmed the model's accuracy across different powder flow behaviors.

Conclusions:

The theoretical model is a successful and validated tool for predicting powder encapsulation in dosator machines.
The model serves as a valuable in silico analysis tool for pharmaceutical capsule development.
Application of the model aligns with and supports Quality by Design (QbD) principles in drug product development.