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Title: The design and characterisation of multiparticulate lipidic systems for oral drug delivery
Author: Coombs, Gemma
ISNI:       0000 0001 2411 9952
Awarding Body: University of Strathclyde
Current Institution: University of Strathclyde
Date of Award: 2013
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The aim of the current research was to develop a sustained release hydrophobic matrix drug delivery system utilising extrusion spheronisation. The initial formulation supplied was Sebomin® MR 100mg capsules, an oral modified release commercial product. A technological transfer was undertaken to reproduce the Sebomin® multiparticulate product utilising lab-scale extrusion/spheronisation equipment. On successful completion, modulation of various processing parameters and the effect on the resultant granule and pellet characteristics evaluated. The potential to develop a sustained release wax matrix formulation via the current technology was unsuccessful and led to the development of a hot-melt spray system. To characterise and validate the hot-melt spray system, OFAT and experimental design approaches were utilised. The process proved to be robust and reproducible in the production of sprayed wax granules. A stability study of the sprayed glyceryl monostearate (GMS) granules indicated the production of the unstable α-form of GMS, during storage the GMS reverted into the stable β-form. Incorporation of active pharmaceutical ingredients and additional excipients into the sprayed wax matrix system enabled in-vitro properties to be evaluated from both sprayed solid solutions and solid dispersions. Screening techniques including differential scanning calorimetry, FT-IR, hot-stage microscopy, X-ray powder diffraction, scanning electron microscopy and dissolution testing were successfully employed to identify changes to the physicochemical properties of materials that may impact product performance.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available