How Process Simulation Enhances Tablet Compaction in Pharmaceutical Manufacturing?

1. Tablet Compaction and Influencing factors?

In the pharmaceutical Industry, tablet compaction is the process of making a tablet unit by agglomerating processed powder. The compaction process is achieved by?filling of powders into a tablet die, and secondly compressing process of filled powders in a die by upper and lower punches, and finally, the ejection process of a compacted tablet from a die.??

During this tableting process, several intermediate structural parameters must be closely assessed to determine the final tablet.?

Influencing Parameters and their assessment?

1. Particle Behavior:? Study and analyze the particle behavior from its physical properties, and assess its attraction forces, porosity, and tortuosity when interacting with neighbouring particles. Also, particle size analysis, and particle size distribution plays a vital role in making a successful agglomeration.?

1. Compression Temperature condition: Compression at varied temperature conditions. ?

1. Particle interaction outcome: Forces acting on particle, adhesion & cohesion nature of particles for tableting, stress on the particles.?

1. Particle weight

1. Critical Process Parameters: Residence time, shear forces, intensity of particle for better agglomeration for better outcome.?

2. Issues: Why Tablet Compaction cannot Happen Proper

Tableting by Compacting powders is a crucial step in the tablet manufacturing process, but it can encounter several issues that affect tablet quality and production efficiency. The issues include:?

• Powder Flowability: Powders with poor flowability can lead to uneven distribution and inconsistent filling of the tablet die cavity, resulting in poor tablet content and blend uniformity. This can be caused by particle size distribution, shape, surface properties, or electrostatic charges. Flowability issues may be addressed by understanding physical behavior of powder, and modifying the powder blend composition, or optimizing processing conditions.?
• Powder Segregation: Powder segregation during compaction can lead to variations in tablet composition and properties. This can occur due to differences in particle size, density, or compressibility of the powder components, Ensuring blend uniformity and optimizing processing parameters for mixing intensity and duration can mitigate this issue.?
• Powder Compression Quality: Poor tableting with low hardness or friability can happen due to inadequate compression pressure or dwell time during tablet compaction. Insufficient compaction pressure, incorrect tooling assessment, or inadequate lubrication are other factors for poor tableting compaction. Understanding compression parameters, tooling design, and monitoring equipment and powder performance can help ensure proper compaction and tablet integrity."?

• Powder Sticking & Picking: Sticking and picking issues can be caused by inadequate lubrication, high moisture content, or interactions between tablet ingredients. Understanding the particle content and its behavior, understanding and controlling moisture levels, and optimizing processing parameters can prevent sticking and picking problems?

Tablet Compaction efficiency can be improvised achieving consistent tablet quality and performance by addressing these things using process modelling simulation requiring material composition in formulation, unit process workflow, unit operating conditions, and compaction-related challenges.?

3. How Compaction Process Modelling Simulation will benefit in powder tablet compaction?

Simulation for tablet compaction utilizes the computational models to understand and predict the particle force & bulk stress, the spatial and temporal evolution of porosity & tortuosity and other powder behavioral aspects during the compression process. These simulations help in making informed decisions considering the structural phenomenon of candidates involved, scope to study the effect of powder properties and operational parameters during the compaction process, thereby allowing scope to optimizing tablet manufacturing processes & its operating parameters, decision making on tableting conditions, and troubleshooting on compaction-related issues.?

The key aspects on how simulations could be benefitting tablet compaction:?

Powder/Material Characteristics: Properties of the powder or granules which tends to affect the overall behavior due to interaction with neighboring particles can be designed in simulations. Actual physics is created, which helps in advance to know the material behavior during flowability, compressibility, and particle size distribution impact during the compaction process, etc., Simulation enables the analysis of material behavior under different compaction conditions, allowing tableting scientists to gain insights into compaction phenomena such as particle rearrangement, deformation, and consolidation.?

Parameter Optimization: In simulation process, we can access and alter tableting parameters such as tablet formulation, volume, compaction force & speed to match the tablet press capacity, and tooling design within the simulation environment. One can observe their impact on the quality and properties of the final tablet, and will have scope to optimize the process for desired outcomes.??

Compaction Process Visualization: Simulation software which is used to simulate the complete unit operation process allows you to visualize the entire compaction process, from the initial powder arrangement to the final tablet formation. This visual representation helps in understanding how different parameters affect the process and enables further understanding of downstream processes such as coating and packaging, assessing quality, efficiency, and effectiveness. Simulation can also facilitate scale-up of tablet manufacturing for various equipment variations by changing the geometry input in simulation software.?

Troubleshooting: Simulating the entire unit operation by simulation software, helps troubleshoot issues encountered during the compaction process. Root cause analysis, and iteratively optimizing the processes, conditions, & material characteristics will allow to judge on details for optimum processing conditions for tablet compaction to implement in equipment.?

Time Saving & Cost Saving: Virtual experimentation such as simulating the entire unit process of tablet compaction will reduce the physical trials thereby minimizing the physical material usage which saves the cost of product. As simulation study and its output directly reflects on product’s outcome in terms of saving time to market.?

4. Issues and Control Strategies in Process Modelling & Simulations?

Process Simulation allows to put control strategies in place as the insights and understanding on material properties, processing conditions, and processing parameters are optimized to suit the needs of better quality outcome of tableting product.?

Compaction Process Monitor & Control: Virtual processing through simulation allows to continuously monitor critical process parameters such as compaction force, tablet thickness, weight, and hardness. A control system can be brought in advance which adjusts the process parameters in real-time to maintain desired tablet quality.?

Powder Material characterization & Control: Exact and correctly characterized material inputs to simulation software present the accurate behavior of powder material during tablet compaction. Factors such as particle size distribution, moisture content, and flow properties of the powder blend helps control & optimize compaction parameters and ensure uniform tablet quality in real time.??

Process validation & Control: Process simulation can recommend establishing processes and relevant controls. The changes in compaction process designed virtually allows to retrospect the tablet compaction is meeting predefined quality standards to adjust in real time.?

Process Optimization & Continuous Improvement: Simulating the process will allow with a scope to continuously optimizing compaction parameters and process conditions through virtual process modelling and experimentation and doing a thorough data analysis generated by simulation software. Iterative implementation of recommendation in simulation software helps identify opportunities for improving tablet quality, increasing productivity, and reducing production costs in real time tablet compaction experiments.?

5. PharmaDEM Solutions Expertise in Process Modelling & Simulations?

PharmaDEM Solutions, founded in 2020, is a leading player in the pharmaceutical sector, providing innovative engineering and consulting services worldwide. The company specializes in deep studies through modeling and simulations for scale-up process manufacturing.?

PharmaDEM possesses expertise in understanding particulate behavior through various characterization studies on powder particles. Their knowledge extends to building the physics behind scale-up processes, considering interactions between particles and surfaces, crucial for determining product efficacy and achieving better outcomes.?

Utilizing DEM (Discrete Element Method) theory, PharmaDEM addresses issues such as particle flowability and various tableting processes through first-principle-based software.?

PharmaDEM Solutions serves as a comprehensive resource for modelling and simulation recommendations across various unit operations including tablet compaction, blending, granulation, color coating, polymer coating, capsule filling, tablet attrition, and pneumatic conveying.?

In the tableting process, PharmaDEM's simulation capabilities provide insight into particle behaviour, aiding pharmaceutical manufacturing plants in making informed decisions and devising contingency plans for optimal outcomes.?

Process Simulation involves modelling unit operations and variable conditions using advanced software tools with AI/ML technologies. This model-driven approach not only provides insights but also aids in preventing batch wastage and optimizing process parameters.?

To know more, visit our website www.pharmadem.in or call us at +919866315475, email us at [email protected]