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A new formulation approach utilising a series of material processing methods for developing less bulky pharmaceutical solid dosage forms


Project Description

Could there be a more cost-effective pharmaceutical formulation approach where considerably less amount of excipients (non-active ingredients) are required, thus making medicines less bulky to allow the combination of multiple medicines to be presented as one reasonably sized unit?

The project will contribute an answer to the question above by design an appropriate dosage system for managing a condition where multiple medication are often required for pharmacotherapy.

Blends of specially modified materials (polymers with comprehensive toxicological data and approved for pharmaceutical formulations in Europe e.g. Soluplus®) will be investigated to determine the minimal and most effective set of ingredients capable of optimal drug release from a solid dosage system. Hot-melt extrusion (HME), spheronisation and fluid-bed coating will be explored for converting these set of materials into appropriate pharmaceutical dosage forms. Comparative assessments with existing equivalent formulations as a reference will be conducted to establish the promise of the newly developed systems.

HME, a molecular level mixing of materials into uniform shape and density by forcing it through a die under controlled temperature, pressure and feed rate will be utilised for enhanced solubility and bioavailability. The possibility of these molecular level mixing compensating for the absence of excipients traditionally employed in pharmaceutical formulations will be explored. Other material modification procedures such as spheronisation, a process converting extrudates into spherical particles with diameters around 0.4mm will be looked into as this has the potential to confer precise, automated capsule filling for mass production and accurate dosing. Furthermore, the high surface area resulting from spheronisation could offer opportunities for enhancing dissolution and bioavailability of the formulation. The many possibilities arising from varying material combinations and processing parameters will create the room and flexibility to tailor formulations to have specific characteristics for desired outcomes. Subsequently, the physical and chemical characteristics, suitability and functionality of systems developed will be assessed to determine how useful they could be as pharmaceutical dosage systems.

Subjecting polymers and multiple drug substances to the above processes potentially could form entirely new substances especially if the drugs being processed undergo a chemical reaction. Hence the final processed products will be studied using analytical procedures including nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS) to elucidated and establish the identity of products as this is vital for safety and functionality. Also, molecular level drug-polymer interactions would be studied using spectroscopic techniques to further our understanding of the impact of these interactions on dosage formulation, as currently, there is paucity of such knowledge in this area of research.

Pursuing this different (novel) approach to formulating solid dosage forms is crucial as outcomes could potentially set a new paradigm for pharmaceutical formulations. It will be the first time several well-established material processing methods and specially modified materials are being explored concurrently to develop solid pharmaceutical dosage forms.

Furthermore, the nature of these systems i.e. spheres with diameters under 0.5mm will allow for easy combination of formulations of different drugs to be encapsulated and presented as a single unit. This can offer tremendous opportunities for combining multiple medications often taken together and presented in a single unit, thus simplifying such regimen and considerably reducing the pill burden on patients (especially older population) as well as the cost of medicines.

Key deliverables at the end of this project will be:
1. A new pharmaceutical dosage system with reduced excipients but functionally comparable to its conventionally formulated equivalent
2. New information detailing material combinations, process parameters and expected outcomes as gathered from this research.

Entry requirements:

Applicants should have or expect to obtain a first or upper second class honours degree (or equivalent) in an appropriate subject and a Masters (at Merit or above) in Pharmaceutical Science or closely related subject.

How to Apply:]] To apply please go to https://www.kent.ac.uk/courses/postgraduate/784/pharmacy
You will need to apply through the online application form on the main University website. Please note that you will be expected to provide personal details, education and employment history and supporting documentation (curriculum vitae, transcript of results, two academic references). You are not required to submit a research proposal.

Funding Notes

This project will be funded by a University of Kent Vice Chancellor’s Research Scholarship. Funding will include tuition fees at the Home/EU rate (currently £4,327 per annum) and a stipend at the standard UK Research Councils' rate (currently £15,009).
The Vice Chancellor’s Research Scholarship is available to both UK and EU nationals and will involve undertaking teaching/demonstrating duties during the period of study.
Note: Overseas students are welcome to apply but will have to fund the difference between Home/EU and Overseas fees.

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