Thesis
Design and evaluation of ophthalmic formulations in an unlicensed medicines manufacturing unit
- Creator
- Rights statement
- Awarding institution
- University of Strathclyde
- Date of award
- 2018
- Thesis identifier
- T14995
- Person Identifier (Local)
- 201292740
- Qualification Level
- Qualification Name
- Department, School or Faculty
- Abstract
- Bespoke unlicensed medicines manufactured as ‘specials’ often have qualityattributes that are minimally qualified with little formal assessment of thebenefits and risks associated with their clinical use. Mitomycin C is acytotoxic antibiotic used as an unlicensed ophthalmic medicine in ocularsurgery and the treatment of ocular malignancies. Amphotericin B is anantimycotic agent used in ophthalmology to treat eye fungal infections. Bothcompounds have limited aqueous stability which restricts its clinical usage.For this reason, the development of innovative ophthalmic formulations withsuperior stability was pursued.As part of the design, drug stability of the formulations was determinedusing a validated HPLC method with samples tested periodically. Also,characterisation of the pharmaceutical products was carried out as part of theevaluation.The novel mitomycin C formulation represents a substantial improvement inshelf life of at least 16 months at 4°C compared to 6 weeks shelf life of theexisting clinical formulation. A toxicological evaluation of the novelmitomycin C eye drops showed that this formulation had a comparableprofile to the aqueous mitomycin C solution.On the other hand amphotericin B products were also developed as eyedrops, in situ and ready to use gel formulation. The instability and thepossible drug-excipient interaction of the in-situ gel formulation make thisoption unfit for purpose. In terms of the other 2 products, either the eyedrops or the ready to use gel stored at 4°C have superior stability than theformulation currently manufactured at the Pharmacy Production Unit withinNHS in GG&C. Although the characterization of the eye drops showed betterresults and the manufacturing process is easier, the ophthalmic gelformulation could imply a better acceptance by patients.These findings will reduce manufacturing costs and extend patient accessimproving the treatment of ocular pathologies. In vivo research to evaluatethe ocular bioavailability of the novel ophthalmic formulations would bedesirable.
- Advisor / supervisor
- Watson, David
- Mullen, Alex
- Resource Type
- Note
- Previously held under moratorium from 3rd October 2018 until 3rd October 2022.
- DOI
- Date Created
- 2018
- Former identifier
- 9912631892602996
Relations
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