mSAS® strategies for enhanced intellectual property
Intellectual Property (IP) is an important element of any pharmaceutical development programme. It allows the value of a product to be realised, and enables sound investment into research and innovation.
Crystec are committed to supporting our clients in securing IP and maximising the life of their products, providing opportunities for enhanced protection through a range of IP strategies.
A unique process
Crystec’s mSAS® (modified Supercritical Anti-Solvent) technology is a unique and proprietary platform developed by a dedicated team of experts with extensive experience in the fields of supercritical fluids and pharmaceutical development. Developed from the principle of exploiting the highly tuneable solubility properties of supercritical fluids (SCFs), and knowledge of a variety of supercritical fluid-based applications, mSAS® has been engineered to maximise versatility and scalability, to support the development and commercialisation of therapeutics across a range of molecule classes and dosage forms.
New solid-state forms
Polymorph screening plays an important role in establishing a robust IP position. Crystec’s mSAS® technology is a highly effective tool in isolating ‘known’ stable and metastable polymorphs, as well as in identifying polymorphic forms unique to the high-pressure SCF environment. As such, mSAS® is often used as an enhanced polymorph screening technique for both new chemical entities and currently marketed APIs. Please see our case study to find out more.
Scalable co-crystals
The motivation for exploring pharmaceutical co-crystals is similar to that of polymorphs, but offers the additional advantage of selecting a range of functional co-formers. Co-crystals provide opportunities for improved pharmaceutical properties (solubility, stability, delivery etc.), in addition to being a powerful source of IP. However, one of the major challenges of pharmaceutical co-crystals is the difficulty in identifying scalable manufacturing processes. mSAS® is a thermodynamically stable process, which provides an attractive, single-step and highly scalable approach to co-crystal manufacture. Furthermore, mSAS® can be used to separate closely related co-crystal forms, which can often prove challenging for conventional processes. Read our case study to find out more.
In-particle design® formulation
Formulation is an often complex process which aims to optimise therapeutic performance, but also underpins the IP position of many pharmaceutical products. Crystec’s mSAS® technology offers an innovative approach to drug formulation, allowing the generation of composite particles containing a uniform and precise ratio of agents (multiple APIs or API plus excipients) in each particle. The intimate mixture of constituents in mSAS® particles can often facilitate improved performance (potentially leading to reduced excipient loading), and can be achieved using a single-step manufacturing process with simultaneous control over a range of particle properties (e.g. particle size, shape, solid-state form). Overall, in-particle design® formulation can be used to both simplify formulations, and to support the development of innovative combination products.
Novel routes of delivery
Enabling alternative routes of delivery can be attractive for many reasons, from improving patient care through easier to use and pain-free products, reducing the burden on healthcare systems by facilitating treatment outside of clinical settings, and providing opportunities for new IP. This is particularly the case with injectable or intravenous dosage forms. However, for many therapeutics, alternative routes of delivery can be prohibitive due to a variety of factors such as first pass metabolism, or the ability to achieve adequate systemic concentrations.
Inhalation offers an attractive route of administration, not only for the local treatment of respiratory diseases, but also for rapid systemic update in the treatment of a variety of conditions. Because mSAS® particles are precipitated directly from solution, they have smooth, low energy surfaces, good flow behaviour, and display strong aerodynamic performance characteristics. This, combined with the ability to tune a range of crucial properties such as particle size, make mSAS® particles particularly suited to targeted lung delivery. To learn more, please read our case study.
Protection through patents and know how
By building performance into particles, mSAS® enables the development of products that perform well in simple, off-the-shelf devices. As a result, the need for complex device development programmes can be eliminated, meaning inexpensive, non-IP encumbered inhalers can be used, while achieving optimal product performance.
Rapid development
mSAS® is a proprietary technology platform designed and operated through extensive know-how acquired over many combined decades dedicated to the advancement of particle engineering and pharmaceutical development. Crystec hold several patents for products developed using the mSAS® platform, and are committed to supporting our clients in securing enhanced IP protection.
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