Shafi, Omar; (2024) Engineering for Obstetrics and Gynaecology: Fabrication of the Transdermal Progesterone Patch. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

This PhD research focuses on developing transdermal patches for delivering progesterone (P4), a steroid hormone crucial in Obstetrics and Gynaecology. The research aims to address the clinical limitations of existing delivery methods like oral and vaginal routes, which often result in waste, discomfort and social stigma. Using engineering techniques such as electrospinning and hydrogelation, the research employs various polymeric systems including Polyvinylpyrrolidone (PVP), Polycaprolactone (PCL), Cellulose Derivatives (CD), Sodium Alginate (SA) and Acrylamide (AA). The role of Polysorbate 80 (PS80) in enhancing permeability was also investigated for all patches in question. This research contains a comprehensive clinical and manufacturing literature review, identifying current P4 delivery practices and limitations. Four main research components yielded promising data: PVP incorporated with PS80 showed an 89% transdermal drug release rate (over two weeks), against just 18% without PS80. PCL-based systems achieved 51% and 66% release rates (over 17 hours) for NoPS80 and YesPS80 fibres, respectively, indicating their suitability for higher P4 doses. From the CD patches, Ethyl Cellulose (EC) and Cellulose Acetate (CA) NoPS80 fibres exhibited release rates (over 70 minutes) of 87% and 82%, respectively, while YesPS80 fibres demonstrated release rates of 98% and 96%, making them particularly relevant for menopausal medicine. Finally, SA-AA hydrogels demonstrated 43% and 53% drug release rates for NoPS80 and YesPS80 patches (over 19 hours), introducing a new method for P4 delivery. Each of the patches underwent rigorous characterisations, including Rheology, Imaging, Fourier Transform Infrared Radiation Spectroscopy, Drug Release, Encapsulation for Dosing and Mathematical Modelling. Upcoming research will address biosafety and cytotoxicity assessments. Areas not yet fully explored that merit additional study will also be acknowledged. This research holds substantial promise for revolutionising P4 delivery methods, potentially making these patches a viable commercial product for clinical practice.

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