Advancing Development through Microstructure Analysis
What are long-acting implants and long-acting injectables?
Long-acting implants, injectables, and contraceptives are designed to provide delivery of drug therapeutics over an extended period of time through engineered delivery systems. Long-acting products can provide constant drug delivery anywhere from weeks to months to years, reducing dose variability and enhancing patient adherence through reduced dosing. Types of long-acting products include implants, intrauterine systems and devices (IUS/IUD), injectable PLGA microsphere depots, and vaginal rings. Some of the treatment areas being addressed by long-acting systems include cancer, schizophrenia, macular degeneration, and prevention of HIV infection.
The performance of long-acting implants and long-acting injectables are highly dependent on microstructures such as particle characteristics and microporosity. While laser diffraction can be used to measured particle size, this is limited to the raw materials, and little can be known about the particle uniformity, distribution, and spacing within the final drug product. For evaluating microporosity, mercury porosimetry is one commonly applied technique. In addition to the complexities of applying high pressure to a soft sample like a PLGA microsphere, mercury porosimetry provides a limited understanding of the porosity distribution and interface with drug particles and polymer. An efficient, high-resolution technique is needed to address these characterization needs.
The DigiM Solution
At DigiM, we work with pharmaceutical scientists to advance development decisions through the lens of imaging. Long-acting implants face increased development time through lengthy formulation and in vitro testing cycles. By reimagining imaging as a tool that can be both quantitative and predictive, our image-based platform has served as a game changer for controlled release and long-acting dosage forms.
Custom solutions for the development of
Our image analysis has been applied to a variety of dosage forms and polymer platforms, including biodegradable polymers like PLGA and biostable polymers such as EVA.
The DigiM Platform
Reimagining imaging through patented A.I. algorithms
Drug particles embedded in a PLGA implant developed for the treatment of macular degeneration, visualized with FIB-SEM.
We apply the 3D imaging techniques of FIB-SEM and X-ray microscopy to visualize the internal structures of long-acting drug products. These techniques provide unprecedented investigation of microporosity, drug particles, and polymer. 3D imaging data can be transformed into a digital twin of the real life sample, allowing for continuous reuse and new image analysis.
Critical Quality Attributes
Through microstructure analytics powered by DigiM I2S, the release mechanisms and performance of long-acting implants can be understood and optimized. We apply advanced AI analytics to classify the material phases seen from images, then quantify their critical quality attributes.
For microporosity and drug particles, key parameters include:
- Particle Size
- Distribution and Uniformity
- Connectivity, Percolation, and Spacing
X-ray microscopy is used to visualize a long-acting implant with resolutions as high as 0.5 micron. AI image analysis can quantify drug particle size, uniformity, and spatial distribution.
Visualized drug release simulation for a PLGA microsphere. Using time-zero samples, image-based release simulation can predict the drug release of a long-acting product in a matter of a few days, compared to weeks and months of in vitro testing.
Utilizing patented algorithms, the DigiM I2S platform can simulate drug release and transport properties directly from 3D imaging data, providing unprecedented correlation and optimization of drug performance through microstructures.
Our suite of image-based simulations include:
- Effective diffusivity
- Mercury injection capillary pressure (MICP) porosimetry
- Image-based release prediction
Solutions for Drug Development of
Long-acting Implants and Injectables
From imaging to image analysis and image-based modeling, we are one-stop shop for all your characterization needs.Our application scientists work closely to design the best workflow for your development challenges. From optimizing formulations to understanding release performance, our image-based solutions have a track record of success in the development of long-acting implants and injectables.
Discover our solutions for:
The DigiM I2S software platform is a comprehensive solution for managing, analyzing, and predicting properties from large image data.The DigiM I2S cloud-based software subscription includes:
- Cloud-based data storage and computing power through DigiM’s in-house computing clusters
- Easy to use with browser interface and mobile access
- Time saving AI-assisted segmentation
- Integrated workflows for image quantification and image-based modeling