Improving Content Uniformity of Morphologically Challenging APIs by Excipient Choice

This study uses Near-Infrared Spectroscopy to demonstrate how co-processed excipients such as PROSOLV® SMCC can improve the content uniformity of direct compression formulations with morphologically challenging APIs.

Register Free: https://www.pharmtech.com/pt_w/content-uniformity

Event Overview:

Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as wet granulation. The improved blending efficacy of co-processed silicified microcrystalline cellulose (PROSOLV® SMCC) versus a physical blend of its component parts has been shown visually, using pigments as a surrogate for the API in the formulation.

This study uses near-infrared (NIR) spectroscopy to demonstrate efficacy with real data. Using two blender types, the uniformity of caffeine, a needle-like API with high static charge, was measured when blended with SMCC, or alternatively with a physical blend of its component parts, MCC and colloidal silicon dioxide. Tablets compressed from the resulting blends were measured for hardness, ejection force, and assay.

Key Learning Objectives:

• Learn how NIRS can be used to quantify uniformity of APIs in blend formulations
• Learn how blending pattern can affect API uniformity
• Learn how excipient co-processing can affect blending efficacy and tablet performance

Speaker:

Stephanie Stewart
R&D Scientist
JRS Pharma

Stephanie Stewart is an R&D scientist at JRS Pharma in Patterson, New York. She received her PhD in Physical Chemistry from the University of Wisconsin-Madison in 2011. Stephanie began her career in the area of surfactants and emulsions for the asphalt paving market. In her 10 years in this field, she gained experience in R&D, sales, and technical marketing roles. Stephanie has spent the last three years diving into pharmaceutical excipient research.

Register Free: https://www.pharmtech.com/pt_w/content-uniformity