Comparative analysis of tablet dissolution behavior: Batch vs. Continuous direct compression.

Area of Science:

• Pharmaceutical Manufacturing
• Process Engineering
• Drug Delivery

Background:

• Continuous manufacturing offers advantages over batch processing but requires early adoption of industrial equipment.
• Batch processes necessitate extensive scale-up studies, which continuous processes can circumvent.
• Utilizing batch trials for early-stage design can streamline the transition to continuous manufacturing.

Purpose of the Study:

• To compare the dissolution behavior of tablets produced by batch and Continuous Direct Compression (CDC) methods.
• To assess the transferability of batch trial data for designing continuous manufacturing processes.
• To evaluate predictive models for continuous manufacturing based on batch data.

Main Methods:

• Immediate-release tablets with ibuprofen were manufactured using batch and CDC methods.
• A Design of Experiments (DoE) approach varied formulation properties and tensile strength.
• Dissolution behavior was analyzed using similarity factor (f2), Weibull modeling with Partial Least Squares (PLS) regression, and Gaussian Process Regression (GPR).

Main Results:

• Identical dissolution profiles were observed between batch and CDC tablets when formulations and tensile strength were matched.
• Deviations in dissolution were primarily attributed to variations in actual tensile strength.
• The Gaussian Process Regression (GPR) model, trained solely on batch data, accurately predicted CDC dissolution profiles (mean R² = 0.910).

Conclusions:

• Batch trials can effectively predict the dissolution behavior of tablets manufactured via Continuous Direct Compression (CDC).
• The transferability of batch data is confirmed, enabling robust formulation and process design for continuous manufacturing.
• This approach enhances the efficiency of developing continuous manufacturing processes for solid dosage forms.