Formulation design of granules prepared by wet granulation method using a multi-functional single-punch tablet press...

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Tablet formulation and manufacturing require robust methods for predicting processability.
• Current methods may not fully capture the complexities of scale-up from laboratory to commercial production.

Purpose of the Study:

• To assess the utility of a visual evaluation method for "Tableting properties" (Compactability vs. Manufacturability) in wet granulation tablet formulation design.
• To determine if this method can predict tableting failures during scale-up to a commercial rotary tablet press.

Main Methods:

• Utilized a multi-functional single-punch tablet press (GTP-1) to measure "Tableting properties" (Compactability and Manufacturability).
• Varied concentrations of binder, disintegrant, and lubricant in tablet formulations prepared by wet granulation.
• Compared GTP-1 evaluation results with outcomes from compression on a commercial rotary tableting machine.

Main Results:

• Tableting failures, including capping and binding, were observed on the commercial press when samples showed poor "Compactability" or "Manufacturability" on the GTP-1.
• The GTP-1 evaluation method successfully predicted potential tableting failures at the commercial scale.

Conclusions:

• The developed evaluation method for "Tableting properties" is a reliable predictor of commercial-scale tableting success.
• This method can significantly aid in formulation design and de-risking the scale-up process for tablet manufacturing.