Articles
Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023
In a recent publication, the trends in ASD drug products over a 12-year period from 2012 to 2023 were analyzed. The review highlights the role of AustinPx's KinetiSol Technology, a solvent-free process that provides significant advantages over traditional methods like spray drying. KinetiSol's ability to process thermolabile compounds and improve drug stability and bioavailability is emphasized as a key innovation in the field of amorphous solid dispersions.
The article notes that KinetiSol has been increasingly adopted for its efficiency in scale-up processes and its versatility in handling a wide range of drug formulations. This technology is also noted for addressing common challenges in the pharmaceutical industry, offering a robust solution for developing modern, patient-centric drug products.
Pharma Matters Q&A: AustinPx, Talking Next-Gen Amorphous Dispersion Technology
Dave Miller, Chief Scientific Officer of AustinPx, discusses in a recent Q&A why our innovative KinetiSol Technology will revolutionize amorphous solid dispersions (ASDs) for poorly soluble APIs. Unlike traditional spray drying, KinetiSol uses a solvent-free process, enhancing stability and bioavailability by preventing phase separation and directly dissolving drugs in polymers.
Miller explains how KinetiSol supports sustainable manufacturing by reducing solvent waste and offering economic benefits. The technology also accommodates thermally sensitive APIs and high melting point compounds, broadening the formulation toolbox. This versatile solution streamlines development timelines and ensures consistent quality from lab-scale to commercial production, making it a game-changer in the pharmaceutical industry.
Less Mess, Less Stress, Best Expressed: A Superior Alternative To Spray Drying
In a recent article, Chris Brough, CTO of AustinPx, highlights KinetiSol Technology as a superior alternative to spray drying for amorphous solid dispersions (ASDs). Unlike spray drying, which relies on organic solvents and nitrogen, KinetiSol uses a solvent-free process that directly dissolves drugs in polymers, preventing phase separation and enhancing stability and bioavailability.
KinetiSol streamlines the scale-up process by maintaining consistent parameters from lab-scale to commercial production, mitigating risks associated with drug degradation and particle size changes. KinetiSol also accommodates thermolabile APIs and offers a broader formulation toolbox, making it a versatile and efficient solution for modern pharmaceutical manufacturing.
How Difficult Is it to Scale Up an Amorphous Dispersion?
AustinPx's Justin Keen, Senior Vice President, Operations explores the scaling up of KinetiSol Technology. This innovative, solvent-free process rapidly transforms active pharmaceutical ingredients into high-quality amorphous solid dispersions, enhancing solubility and bioavailability. KinetiSol simplifies scale-up by controlling a single variable – shear rate – making the transition from lab-scale to commercial production seamless and efficient.
Keen highlights how KinetiSol addresses the challenges of traditional techniques like hot melt extrusion and spray drying, offering a more sustainable and efficient solution for drug development. At AustinPx, we leverage KinetiSol to improve poorly soluble drug candidates, accelerate development timelines, and achieve cost savings, driving the future of pharmaceutical manufacturing.
How prioritizing sustainability efforts yields long-term growth in drug manufacturing
Pharmaceutical companies that invest strategically in sustainability initiatives will differentiate themselves in a competitive market. Implementing these practices ensures a robust and long-term market position, enabling stakeholders across the value chain to overcome post-COVID challenges, innovate, and secure a more sustainable future for the industry.
With KinetiSol Technology, drug developers have a better option for developing ASDs and the opportunity to reduce their carbon footprint while accelerating development and lowering their manufacturing costs for final drug products.
How sustainable practices in pharma drive long-term growth
Embracing sustainability is not just socially responsible but also strategically beneficial, driving long-term financial returns and strengthening relationships with patients and the broader community.
At AustinPx, sustainability, innovation, and client-centricity are our pillars as a CDMO. Our KinetiSol Technology doesn’t just offer a more sustainable method for developing poorly soluble drug candidates, it provides improved performance, accelerated development timelines, and cost savings.
DCAT Sustainability Leaders
The first edition of The Sustainability Leaders, an eBook presented by DCAT, is now available. AustinPx is one of the sustainability leaders highlighted in this eBook, as well as the efforts of other DCAT Member Companies that are contributing positively to the environment. You shouldn't miss this opportunity to discover the praiseworthy initiatives being taken toward a sustainable future. Download the eBook now! https://lnkd.in/erM_rFCW