Microstructure Solutions
for Big Challenges
Microstructure Solutions for Big Challenges
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Microstructure Solutions
for Big Challenges
Microstructure Solutions for Big Challenges
Challenging pharmaceutical development problems require innovative solutions. At DigiM, we believe that quantitative microstructure analysis is one such tool. From solid dosage forms to lyo cakes, microspheres to implants, microstructures are at the core of engineering and optimizing drug product performance. Through advanced AI analytics and image-based simulation, we have helped clients accelerate formulation, process development, and performance troubleshooting.
3D XRM microstructural imaging of a Long-acting PLGA implant
As part of the Long-Acting Drug Delivery System Development and Evaluation Symposium, with additional talks from Ashland and Oakwood Labs. Tuesday, October 19, 2021, 10:00 AM – 10:30 AM ET, Location: 113 ABC, Pennsylvania Convention Center.
The internal microstructures of microspheres and implants, such as API uniformity and microporosity, are critical towards understanding and optimizing their release performance. Current methods lack the resolution and efficiency to evaluate these microstructures features to release performance in a timely and cost-effective manner. This work presents an innovative method to characterize long-acting drug delivery systems using image-based release modeling of T0 samples through 3D high-resolution imaging techniques. With AI-based image analysis of pre- and post-dissolution samples, the impacts of biodegradable polymer selection and drug particle characterization on the release mechanism can be visualized and understood. With image-based analytics and release simulation, microstructures and the behavior of biodegradable polymers can be directly correlated with performance.
Micro-CT 3D reconstruction of 50 wt.% Meloxicam in hot melt extrusion matrix.
With Purdue University. Poster presentation on
Monday, October 18, 2021, 9:30 AM – 10:30 AM ET
“Oral administration of non-steroidal anti-inflammatory drugs (NSAIDs) predisposes patients to systemic side effects. Sustained local delivery of NSAIDs is a reasonable alternative when inflammation is regionally confined. We aim to develop a sustained delivery system of meloxicam, a COX2 inhibitor, over 14 days – a critical time frame for post-surgical wound management and prevention of biofilm formation. Here, we have produced meloxicam-eluting polymeric matrices by hot melt extrusion (HME) and investigated the mechanism by which the matrices control drug release.”
SEM images of PLGA microspheres; a) Formulation A, b) Formulation B, c) Formulation C, d) Formulation D.
With the FDA and UCONN. Poster presentation on
Tuesday, October 19, 2021, 10:30 AM – 11:30 AM ET
“Commonly used manufacturing methods for poly (lactic-co-glycolic acid) (PLGA) microsphere drug products include solvent evaporation, coacervation (phase separation), and spray drying. Minor changes in the manufacturing processes have been shown to affect the physicochemical properties (such as drug loading, particle size, and morphology) and drug release behavior of microspheres. The objectives of this work were to investigate the effect of coacervation processing parameters on PLGA microsphere quality and in vitro release characteristics.”
FIB-SEM images of a) RLD (D830), b) In-house formulation (D1153) , c) In-house formulation (D1128), d) In-house formulation (D1271). API particles are annotated and red arrows are pointing towards pores.
With the FDA and UCONN. Poster presentation on
Monday, October 18, 2021, 3:30 PM – 4:30 PM ET
“Poly(lactic-co-glycolic acid) (PLGA) encapsulation continues to play a dominant role in the formulation of controlled release microspheres. Qualitative (Q1) and quantitative (Q2) equivalence of PLGA products are often inadequate to ensure therapeutic performance equivalence. The assessment of microstructure equivalence, in terms of drug uniformity intra-sphere and inter-sphere, drug particle distribution, and porosity, is therefore critical to an effective characterization to support generic drug development and potential regulatory assessment of product quality and equivalence. Employing innovative microstructure imaging and quantification tools, this work demonstrates PLGA microsphere formulation development guided by microstructure equivalence assessment.”