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  Functionalised silicone elastomers for controlled release drug delivery


   School of Pharmacy

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  Prof Karl Malcolm  No more applications being accepted  Competition Funded PhD Project (UK Students Only)

About the Project

It is increasingly acknowledged that drug delivery is a key factor in developing new medicines, and that new polymeric biomaterials will play a critical role in driving innovation. In 1964, researchers first demonstrated that small molecules – including certain dyes and drugs – were able to diffuse slowly from silicone elastomer capsules implanted in animals. Silicone elastomers have since been exploited for a myriad of controlled release drug delivery applications, including intrauterine devices, vaginal rings, subdermal and other implants for contraception, estrogen replacement therapy, HIV prevention, and treatment of bladder cancer and eye diseases. However, to date, all marketed drug delivery products containing silicone elastomers are fabricated from a single silicone chemistry – referred to as polydimethylsiloxane – in which the silicone polymer is functionalised only with methyl groups. Surprisingly, although silicone elastomers having other functional groups are well-established in the medical device, electronics and aerospace industries, they have neither been extensively investigated nor exploited for use in drug delivery devices. In this project, for the first time, we will assess the potential for controlled drug release from chemically functionalised silicone elastomers. Specifically, working in partnership with NuSil – the global leader in the synthesis, formulation and supply of silicone excipients for medical and drug delivery applications – the aim of this project is to assess the potential for controlled release drug delivery from silicone polymers/elastomers containing methyl, phenyl, trifluoropropyl and custom hydrophilic groups.

The objectives of the project are:   

  1. To measure the solubility characteristics of model drugs (dapivirine, metronidazole and gemcitabine) in silicone polymers containing various methyl, phenyl, trifluoropropyl and custom hydrophilic moieties
  2. To assess the isothermal cure characteristics of the various silicone elastomer materials, both without and with inclusion of model drugs
  3. To test release of model drugs from the various silicone elastomers, and mathematically model the data to obtain drug diffusion coefficients, drug permeation coefficients, release rates, lag/burst times, etc.
  4. To assess the extent of swelling in aqueous media of devices manufactured from the various silicone elastomers
  5. To assess the mechanical properties of devices fabricated from the various silicone elastomers
  6. To assess the potential for combining the multiple silicone elastomer types within reservoir-type devices for further modulation/control of drug release rates
  7. To provide the student with a 3-month immersive industrial research experience at NuSil’s R&D facility in California around the synthesis and formulation of a custom hydrophilic silicone elastomer

CAST (PhD) STUDENTSHIPS

provide for the payments of approved fees and the maintenance of students on Research Studentships intended to encourage the development of collaboration between universities and industry and, in particular, to provide an opportunity for graduates to undertake PhD research of direct interest to industry.

How the project aligns with Prof. Malcolm’s research

I am a world-leading academic researcher with extensive practical and commercial knowledge/expertise in developing controlled release drug delivery products, most notably for use in women’s sexual and reproductive health. For example, the antiretroviral-releasing silicone elastomer vaginal ring product I conceived and helped develop over the past twenty years is now being used by women across Africa for prevention of sexually-acquired HIV infection. In fact, most of the 100+ research articles I have published over the past 25 years have focused on silicone elastomer materials. This project affords a unique opportunity for partnership between a world-leading academic and the world-leading silicone company to advance new innovations in the drug delivery field.

How the project aligns with Queen's University Belfast priorities

The project aligns strongly with QUB’s Strategy 2030 research ambitions, including: (i) contribute meaningfully to UN Sustainable Development Goal 3 ‘Ensure healthy lives and promote well-being for all at all ages’, and specifically Targets 3.3 and 3.7 relating to HIV prevention and women’s sexual and reproductive health, (ii) expand reach through strategic global co-operation and collaboration, (iii) build research partnerships internationally, and (iv) enhance QUB’s reputation as a global research-intensive university delivering innovation and impact.

https://www.economy-ni.gov.uk/sites/default/files/publications/economy/Postgraduate-Studentships-Terms-Conditions-2023-24.pdf

The candidate must be ordinarily resident in the UK or Islands, including the Channel

Islands and Isle of Man, for the full three year period before the first day of the first

academic year of the course, i.e. normally 1 October (or would have been so resident

had the candidate, the spouse or either parent not been employed temporarily

outside the UK or the EU).

For Non-EU nationals – the main purpose of residence in the UK must NOT have

been to receive full time education during any part of that three-year period.

Candidates with pre-settled or settled status under the EU Settlement Scheme,

who also satisfy a three-year residency requirement in the UK prior to the start of

the course for which a Studentship is held MAY receive a Studentship covering

fees and maintenance.

Republic of Ireland (ROI) nationals who satisfy three years’ residency in the UK prior to the start of the course MAY receive a Studentship covering fees and maintenance (ROI nationals don’t need to have pre-settled or settled status under the EU Settlement Scheme to qualify).

Candidates with pre-settled or settled status under the EU Settlement Scheme

MAY qualify for a “Fees only” Studentship if the candidate doesn’t have three full

years’ residency in the UK and Islands but has been ordinarily resident in the area

comprising the UK, Gibraltar, EEA and Switzerland for three years before the start

of the course.

ROI nationals MAY receive a studentship covering fees only if the candidate

doesn’t have three full years’ residency in the UK and Islands but has been

ordinarily resident in the area comprising the UK, Gibraltar, EEA and Switzerland for three years before the start of the course.

Applicants should have a 1st or high 2.1 honours degree (67% of greater; or equivalent) in a relevant subject. Relevant subjects include Pharmacy, Pharmaceutical Sciences, Biochemistry, Biological/Biomedical Sciences, Chemistry, Engineering, or a closely related discipline. Students who have a 2.2 honours degree and a Master’s degree may also be considered, but the School reserves the right to shortlist for interview only those applicants who have demonstrated high academic attainment to date.


Chemistry (6) Medicine (26)

Funding Notes

For UK domiciled students, the value of an award includes the full cost of approved fees as well as maintenance support, both for three years. In academic year 2023/2024 the basic rate of maintenance support for a research studentship was £18,622. This award is not affected by your parent’s income or your income, but if you are receiving similar support from industry or a university, you may not be eligible for a studentship.

References

Applicants should have a 1st or high 2.1 honours degree (67% of greater; or equivalent) in a relevant subject. Relevant subjects include Pharmacy, Pharmaceutical Sciences, Biochemistry, Biological/Biomedical Sciences, Chemistry, Engineering, or a closely related discipline. Students who have a 2.2 honours degree and a Master’s degree may also be considered, but the School reserves the right to shortlist for interview only those applicants who have demonstrated high academic attainment to date.
Postgraduate Research applicants must have applied to Queen’s, via the Direct Applications Portal.
https://dap.qub.ac.uk/portal/user/u_login.php
Please note that applicants do not need to draft a detailed research proposal. Instead, applicants can simply copy and paste the summary descriptive text provided above. However, you may wish to elaborate further on the concept, particularly if you have other ideas around the general topic.
For further information, please contact Prof. Karl Malcolm (k.malcolm@qub.ac.uk)
Prof. Karl Malcolm’s research homepage
https://pure.qub.ac.uk/en/persons/karl-malcolm
The project will provide extensive training and skills development for the student in the following topics:
· drug formulation
· injection molding
· drug quantification using high performance liquid chromatography (HPLC)
· in vitro drug release testing
· use of thermal analysis methods, e.g., DSC, TGA
· rheological and mechanical testing methods
· planning and organising skills: designing and planning of experiments
· numeracy and statistical skills
· teamwork skills: working confidently as part of a large research team
The student will receive additional support from senior researchers working in the Malcolm/Boyd research group.
NuSil is committed to providing an immersive industrial research experience for the student engaged in the proposed project, including a three-month on-site residency at the NuSil R&D facility in Carpinteria, California, US. The student will be embedded in the NuSil Biomaterials New Product Development group, working side-by-side with R&D scientists and technicians in our laboratory and piloting facilities to execute on experimental designs. Prior to engaging in hands-on work, the student will complete the same Safety, Quality, Security, HR, Product and Equipment training required for all new NuSil employees. During the residency, the student will develop familiarity with the equipment and processes used to develop, manufacture, and characterize silicone elastomers, gaining first-hand experience in what it takes to drive a product from concept to commercialization.
The project is well positioned to impact next-generation drug delivery devices offering controlled release of drugs over months/years. The successful applicant will have opportunities to present their research at national and international conferences. The work will be of interest to pharmaceutical companies and silicone elastomer suppliers.
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