(693g) Half Tablet Methodology: Investigating the Relationship between Dissolution Behavior and Raman Chemical Imaging
AIChE Annual Meeting
Thursday, November 14, 2019 - 2:36pm to 2:57pm
This study focuses on using a commercial three-dimensional (3D) Raman Imaging system (H2Optx), as an off-line measurement system, to find a relation between chemical information obtained from Raman Imaging and API dissolution. Till now, extensive structural studies have not been conducted to study this relationship using Raman Imaging.
In this work, Ibuprofen (D50: 70 Âµm) is jet milled to two more particle size ranges (D50: 28 and 11 Âµm) following by mixing with Fast Flo Lactose (filler) and Magnesium stearate (lubricant) a V-Blender with two levels (high and low) of shear. The six conditions were expected to have contrasting dissolution behaviors and Raman Chemical Images. Post blending, tablets were manufactured using an MCC Presster (a rotary tablet press simulator). An FT-NIR Transmittance based PLS regression model predicted the API content in each of the marked tablets. The âdeviatedâ and ânormalâ tablets from each of the experimental conditions were cut in half with minimal powder loss. One-half (from each of the tablets) was used for dissolution test while the other half was used for 3D Raman Imaging. Statistical comparison of 3D Raman Images and dissolution profiles revealed the relationship of the chemical microstructure to the dissolution process. The overall methodology is described in the figure below: