BENEFITS OF THE COUNTINUOUS WET GRANULATION LINE
Several advantages of the continuous wet granulation line process may exist. The continuous process, a process prediction model, twin screw extrusion, and a Raman spectroscopy approach for continuous API quantification during high-shear wet granulation are all covered in this article.
PREDICTIVE MODEL FOR A CONTINUOUS WET GRANULATION LINE
To guarantee high-quality end products, continuous wet granulation processes must be monitored in real-time. The moisture content and particle size are the main characteristics that need to be watched. These qualities have been measured using a variety of optical techniques. Both Raman and near-infrared spectroscopy are frequently employed. These optical techniques have a number of benefits, including non-invasive monitoring. However, these techniques necessitate the connection of the wet powder to a probe window, which may make it challenging to get representative data. Acoustic emission is an additional technique for in-line monitoring.
We also looked into several granule characteristics and how they related to granulation development. Our findings demonstrated that the PLS model was capable of accurately predicting the crucial granule features. We discovered that the granules’ expected attributes had high coefficients of determination. Additionally, we discovered that the examined granule properties had low RMSECV and RMSEP values. Additionally, a significant variable that impacted the accuracy of our calibration was the bulk density of the granules.
In-line near-infrared spectroscopy is another helpful technique for examining granule characteristics in high shear wet granulation processes. Eleven batches were used for calibration using this procedure, and another batch was used for validation datasets. The granules’ chemical and physical changes were connected with the NIR spectra. We also used chemometric to assess the particle size.
EXTRUSION WITH TWIN SCREW EXTRUDERS
Pharmaceutical substances are produced using twin screw extruders. The self-wiping, intermeshing twin screw extruder has a large output while maintaining the optimum mixing and conveying properties. In 1986, paracetamol was first produced using twin screw extruders. The creation of new medicine formulations was sped considerably by its application in the pharmaceutical sector. Since then, a variety of pharmaceutical applications have made use of the technique.
Depending on their screw diameter, twin screw extruders have different configurations. Some are five millimeters in diameter, while others are ten, twelve, or sixteen millimeters
While the largest versions are intended for pilot and commercial production, the smallest ones are ideal for laboratory development. One of the top producers of continuous twin screw granulators is Bohle.
Twin screw extruders are appropriate for OSD pharmaceutical continuous manufacturing procedures. These extruders can process pharmaceutical granulates in both dry and wet forms. Twin screw extruders are appropriate for small-scale manufacturing as well. They also have little downtime and have online monitoring.
RAMAN SPECTROSCOPY METHOD FOR CONTINUOUS API QUANTIFICATION DURING HIGH-SHEAR WET GRANULATION
The Raman spectroscopy technique is a crucial instrument for pharmaceutical products’ continuous API quantification. This method can be used to pinpoint crucial formulation factors, assess the formulations’ quality characteristics, and enhance analytical models. It has evolved into a crucial element of modern good manufacturing practices in the production of pharmaceuticals.
An in-line Raman spectroscopy device can be used to continuously quantify API during high-shear granulation. With this technique, a Raman probe is placed in front of the granulator barrel, and Raman spectra are continually gathered. To create an in-line PLS calibration model for the investigation, eight binary mixes of API and lactose monohydrate were pre-blended and granulated. The model needs to be calibrated and contrasted with real data in order to determine the reliability of the Raman approach. The fit of the calibration model is examined, for instance, using the RMSECV value. However, the outcomes of the examination of tablets coated in a specific hue.