Abstract
UV imaging has seen a rapid expansion in providing early insights into drug API behaviour in vivo due to the versatility of the UV imaging setups. These insights into API behaviour have proved useful in providing an understanding for phenomenon usually difficult to otherwise explain. The SDi2 UV imager offers a platform which facilitates UV imaging of drug compact intrinsic dissolution rate (IDR) determination as well as whole dose dissolution imaging.The work presented in this thesis is a collaborative approach between the School of Applied Sciences and School of Engineering at the University of Huddersfield to expand the application of the SDi2 imaging instrument to characterise topical dosage forms (creams, gels, ointments etc.). To this end, a proof of concept research is undertaken to develop a novel diffusion cell secured in the SDi2 UV imager, which allows UV permeation imaging. The novel cell is manufactured by a 3D printing method in the similitude of a Franz cell. The dosage form is administered through the donor compartment, and the drug concentration permeated through the skin or skin mimic is determined from the receptor compartment by UV imaging in real-time. Upon successful manufacturing of the proof of concept Franz cell, two model formulations ketoprofen gel and ibuprofen gel were tested. The results showed a successful permeation and imaging process thereby showing the Franz cell imaging concept to be moved towards commercialisation.
In addition to the development of the novel diffusion cell, two more proof of concept developments are detailed. Among these, the first development, design and manufacture of a smooth-surfaced insert for the IDR compact tooling which allows manipulation to the drug compact surfaces to achieve uniform textured surfaces. To this end, a compact tooling rig is designed and manufactured that can produce multiple inserts for the IDR process. An Infinite Focus Microscope (IFM) is used to measure the surfaces (surfaces of the compacts produced from the developed inserts as well as the surfaces of the compacts produced without the inserts). Results from a model drug glibenclamide (GBM) showed that the smooth inserts which were manufactured produced relatively smoother surfaces which may impact IDR measurements.
The second development pertains to the design of standardised holders for SDi2 whole dose cell that removes user variability. SDi2 whole dose dissolution cell currently available does not have the standard holders to secure standard capsules and tablets. A simple loop is made with a steel wire to secure different sized dosage forms. This work also explored, designed and developed holders for standard-sized capsules and tablets. The holders are manufactured by a 3D printing method. A holder which does not cause hindrance to the swelling, disintegration and erosion process is proposed.
| Date of Award | 19 Nov 2019 |
|---|---|
| Original language | English |
| Supervisor | Kofi Asare-Addo (Main Supervisor), Karl Walton (Co-Supervisor) & Liam Blunt (Co-Supervisor) |