From its location in-between Uppsala University, Swedish Medical Products Agency and Uppsala University Hospital, Disruptive Materials AB is well positioned to exploit its groundbreaking discovery of Upsalite®, a unique mesoporous magnesium carbonate with the highest surface area ever measured for an alkaline earth metal carbonate and a pore structure that can be precisely tailored in a an efficient and environmentally friendly manufacturing process.
Formulation and drug delivery is one of the key applications of Upsalite, and the aim of Disruptive Materials and its 15+ employees is to make Upsalite the recognised first-hand-choice for poorly soluble drugs. The limited oral bioavailability of poorly soluble drugs continues to be a major challenge for the pharma industry, despite decades of development efforts and numerous formulation technologies. Upsalite offers a way forward for the worst among poorly soluble NCE drugs, as well as an opportunity for poorly soluble generic drugs hampered by low and/or highly variable bioavailability.
It is a well-known fact that the dissolution rate is higher for the amorphous form of a poorly soluble drug than from its various crystal forms. However, the amorphous state is inherently unstable and tends to recrystallise back into the poorly soluble form. As such, amorphous APIs are not feasible for the development of stable and high-quality oral drug products. Various approaches have thus been proposed for the stabilisation of amorphous drugs; for example, hot melt extrusion and spray-drying.
Upsalite has now entered that scene, and is featuring high drug loads, excellent stability and a low-temperature drug-loading procedure. It is an effective and scalable solution that can be already introduced in the preclinical phase, and then go the distance to market.
For many other solubilisation technologies such as cyclodextrins, liposomes and others, the drug/excipient ratio is rather low, compelling an unfortunate choice between dosage strength and dosage size. With drug loads up to 50% w/w for Upsalite, there is no contradiction between a high strength and convenient, normal-sized tablet or capsule. Scientists at Disruptive Materials are now pushing forward, studying Upsalite's compression characteristics and other tablet-manufacturing properties.
It was supposed to be impossible.... but we did it!
Up until Disruptive Materials' breakthrough discovery in 2013, nobody had been able to produce a mesoporous magnesium carbonate. The discovery attracted a considerable media attention around the globe (www.huffingtonpost.com/2013/08/05/upsalite-impossible-material-swedish-lab_n_3709055.html), but the company scientists didn't rest on their laurels. The development of Upsalite into a reliable drug delivery technology, as well as other applications, started soon thereafter.
Disruptive Materials now has three patent families in the portfolio (WO2014087355, PCT/EP2017/057693 and PCT/EP2017/057692) and more inventions in the pipeline.
Strong and unique IP is particularly attractive for life cycle management projects or in the development of so-called new therapeutic entities ("NTE") and 505(b)(2) products.
At the end of the day, it's all about unmet medical needs. If a highly effective but poorly soluble drug can make it through development and onto the market, it can mean a lot to a patient. Upsalite will be one among several features of a successful product - but it can truly make a difference.
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Amorphous stabilisation of poorly soluble drugs is achieved by a narrow pore size distribution in the nm-range.
