Case Studies


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Improving Solubility

The aim of this study was to formulate particles of a poorly soluble drug to enable enhanced oral bioavailability. The target product profile (TPP) was to form particles comprised of an amorphous dispersion of the drug within a polymer matrix. The crystalline drug alone was insoluble in water, so this approach was necessary to enhance dissolution and provide sufficient in-vivo bioavailability. Read More

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Polymorph Study

The aim of this project was to discover new polymorphs of an API to strengthen an existing IP position (only one polymorph was known to exist). An enhanced mSAS® polymorph screen was carried out, identifying one new form. An analytical data package was generated in support of arising patent applications. Read More

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Scalable Co-Crystals

This following case study is on a rheumatoid arthritis drug (a tyrosine kinase inhibitor), conventional technology was unable to reproducibly form a 1:1 co-crystal (API plus co-former). As such, the aim of this project was to generate the 1:1 co-crystal using Crystec’s mSAS® technology and ensure reproducibility. Read More

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Oral to Inhalable

The focus of this project was to develop an inhalable form of the API with a target particle size of less than 5µm. The aim was to improve the in-vitro Fine Particle Fraction (FPF) as a percentage of Total Emitted Dose (TED) of the API, compared to the micronised starting material. Efficacy was evaluated in-vitro using an Anderson Cascade Impactor (ACI), a mechanical model of the human lung. Read More

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Biomolecule Processing

The example case studies below demonstrate some of the key areas where mSAS® drying technology can be applied to overcome the challenges associated with biomolecule processing. Read More

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Traditional Chinese Medicine

The target product profile for material in this case study was production of a dry powder from a herbal mixture of two TCM plant extracts. The starting material was a viscous wet slurry, containing high levels of residual solvent, moisture and numerous impurities. The project aimed to produce a ‘consumer friendly’ dry powder with high levels of uniformity (both in content and appearance), which could be easily formulated into a tablet or capsule Read More