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Rapid Fire Talk: Artificial-Intelligence Image Analysis of API and Microporosity in Drug Products

We present the application of our novel image analysis technology to three case studies: controlled release PLGA microspheres, amorphous solid dispersion tablets, and deep learning image quantification.

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Accelerated Formulation Characterization and Development with AI Image Analysis and Image-Based Release Modeling for PLGA Implant

With Genentech

 Long-acting drug delivery systems require lengthy in vitro testing to evaluate drug formulations and performance. Using DigiM I2S software, we demonstrate how A.I. can accurately characterize microstructures and quality attributes for a PLGA rod implant. The application of image-based release modeling, which can predict month-long release profiles in a matter of days, is also presented.

Abstract here. Request poster.

DigiM Microstructure bioequivalence assessment for Levonorgestrel intrauterine systems IUS

Drug Particle Characterization Inside Long-Acting Intrauterine Systems with 3D Imaging Analytics

With the FDA and UCONN

In this project, we used high resolution FIB-SEM imaging to evaluate and compare the microstructures between a reference listed drug product and an in-house formulated IUS device. The device microstructure, pre and post dissolution, was correlated with each samples in vitro performance.

Abstract here. Request poster.

Formulation Optimization of PLGA Microspheres Prepared Using a Coacervation Method. 

With the FDA and UCONN

The patent describing Arestin® (minocycline HCl), a subgingival PLGA microsphere product containing minocycline hydrochloride used to reduce periodontal pocket depth after scaling and root planing, will be off-patent on March 29, 2022 and accordingly, there may be an interest in developing generic equivalents.  To achieve PLGA microspheres qualitatively (Q1) and quantitatively (Q2) equivalent to each other, and based on the reference listed drug (RLD), Arestin®, formulation optimization of minocycline chloride microspheres prepared using a coacervation method was investigated. Work is presented by Ruifeng Wang at UConn, please reach out to them to gain access to the poster.

Abstract here. 

 

Particle Analysis within Drug Products: Novel Methods in Quantification using 3D Microscopy

Particle characteristic analysis of size, morphology, and distribution is presented in two cases: intra-batch capsule performance differences and spray dried particle process development.

Abstract here. Request poster.