1- Oral Drug Delivery/Formulation
Orodispersible thin films (OTFs) were first established as breath fresheners and have since progressed to the delivery of active pharmaceutical ingredients (APIs). Composed principally of one or more water soluble, film-forming polymers, OTFs dissolve very rapidly in contact with saliva, releasing the active ingredient(s) without the need to chew or drink water. This makes them ideally suited to elderly or paediatric populations, who may have difficulty swallowing other solid oral dosage forms such as tablets or capsules.
This is a growing area with a lot of industrial interest and lack of regulatory information and quick turn over for generic API; therefore the focus will be on the following area:
- Tatse Masking of API
- The use of sweetener and flavour as a taste mask strategy
- Dissolution assays and Biowavier
- Thin film stability following the ICH guidelines
- The use of different film former polymer for different purposes (IR, SR, and wound care application)
2- Oral Biopharmaceutics
As most drugs are taken orally, as tablets or capsules for example. However, designing these pharmaceutical products in such a way that the active ingredient is absorbed at an appropriate rate and extent by the gut is far from easy. Therefore to be able to enhance the understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients.
This is another area of industrial and regulatory interest for which I will follow and continue the research generated and initiated in the oral biopharmaceutical tools project “Orbito” – we will also collaborate with our current industrial partners e.g. GSK, Pfizer, AZ, Novartis and others, and will be linked to colleague in CMAC (Professor Joop Ter Horst, CRUK (Professor Gavin Halbert) and also with the regulatory authorities in UK, Europe and USA.
The focus will be on the following:
- API physicochemical characterization
- Drug solubility in human gastric and intestinal fluids “fed and fasted state” using the DOE approach
- Develop small-scale tests for dissolution, nucleation and supersaturation.
- Develop of predictive tools that the industrial partners can use to predict the behavior of their API.
3- Extrusion, 3D and Chocolate Printing
The applications of three dimensional (3D) printing in the field of pharmaceutical science and medicine are growing rapidly and the technique generates numerous benefits currently and also very promising potential applications in the near future such as drug discovery and delivery and tissue fabrication. 3D printing technology offers many advantages, for example, it permits customization of products and therefore it can be applied on a number of areas, such as drug delivery or tissue engineering.
The work in this area started and project with a leading Pharamceutical Compnay has been initiated which focus on the extrusion of drug loaded filament and the use of 3D printing technology to print a design for female health care.
Also the use of chocolate as drug delivery system for pediatric application is another growing area, the chocolate printer was developed in house and ready to use. This work is coordinated and led by Professor Clive Wilson and myself.