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Title: Design and evaluation of ophthalmic formulations in an unlicensed medicines manufacturing unit
Author: Castaño Aniceto, Marina
ISNI:       0000 0004 7960 8683
Awarding Body: University of Strathclyde
Current Institution: University of Strathclyde
Date of Award: 2018
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Bespoke unlicensed medicines manufactured as 'specials' often have quality attributes that are minimally qualified with little formal assessment of the benefits and risks associated with their clinical use. Mitomycin C is a cytotoxic antibiotic used as an unlicensed ophthalmic medicine in ocular surgery and the treatment of ocular malignancies. Amphotericin B is an antimycotic agent used in ophthalmology to treat eye fungal infections. Both compounds have limited aqueous stability which restricts its clinical usage. For this reason, the development of innovative ophthalmic formulations with superior stability was pursued. As part of the design, drug stability of the formulations was determined using a validated HPLC method with samples tested periodically. Also, characterisation of the pharmaceutical products was carried out as part of the evaluation. The novel mitomycin C formulation represents a substantial improvement in shelf life of at least 16 months at 4°C compared to 6 weeks shelf life of the existing clinical formulation. A toxicological evaluation of the novel mitomycin C eye drops showed that this formulation had a comparable profile to the aqueous mitomycin C solution. On the other hand amphotericin B products were also developed as eye drops, in situ and ready to use gel formulation. The instability and the possible drug-excipient interaction of the in-situ gel formulation make this option unfit for purpose. In terms of the other 2 products, either the eye drops or the ready to use gel stored at 4°C have superior stability than the formulation currently manufactured at the Pharmacy Production Unit within NHS in GG&C. Although the characterization of the eye drops showed better results and the manufacturing process is easier, the ophthalmic gel formulation could imply a better acceptance by patients. These findings will reduce manufacturing costs and extend patient access improving the treatment of ocular pathologies. In vivo research to evaluate the ocular bioavailability of the novel ophthalmic formulations would be desirable.
Supervisor: Watson, Dave ; Mullen, Alex Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral