Thesis

Small scale manufacturing and scintigraphic detection of pellet formulations

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Awarding institution
  • University of Strathclyde
Date of award
  • 2014
Thesis identifier
  • T13816
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Department, School or Faculty
Abstract
  • This research was designed to develop radiolabelling methods for pellets or mini-tablets so that their in vivo behaviour can be assessed using gamma scintigraphy. Eight different pellet formulation profiles were developed using paracetamol and indomethacin as partially and poorly water soluble model drugs respectively. Four different drug release profiles for each of the two model drugs were achieved by applying a film coat to the pellet formulations, which were manufactured using either extrusion-spheronisation or the drug-layering techniques. Pelletisation methods were developed on a small scale in order to minimise quantities of radioisotope required for manufacturing for scintigraphic studies.Extrusion-spheronisation used microcrystalline cellulose and lactose as the main components. Thermally controlled spheronisation at elevated temperature produced pellets within a narrow size distribution. It was found that the drug release rate from extrusion-spheronised pellets could be readily manipulated by changing the ratio of microcrystalline cellulose within the pellets. However, the drug-layering technique was required in order to achieve a rapid release of the poorly water soluble drug indomethacin.Two radiolabelling methods, the "incorporation" and the "soaking" methods, were successfully developed. In the "incorporation" method a 99mTc radioisotope is mixed into a powder blend prior to small scale extrusion-spheronisation and in the "soaking" method inert pellet cores are soaked in a solution containing a 99mTc radioisotope, which becomes attached to the pellet core prior to small scale drug-layering.The use of radiolabelled placebo pellets in gamma scintigraphic studies was validated. It was found that gastrointestinal transit of drug loaded formulations, which may include novel pellet formulations or mini-tablets, can be traced in vivo by mixing with radiolabelled placebo pellets.A faster and easier alternative to the "soaking" method, the "wet and dry" method, was optimised at a later stage.
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Note
  • This thesis was previously held under moratorium from 3rd November 2014 until 3rd November 2016.
DOI
Date Created
  • 2014
Former identifier
  • 9910388323402996

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