The design and characterisation of multiparticulate lipidic systems for oral drug delivery

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.

Name dc:type.qualificationname

phd

Level dc:type.qualificationlevel

doctoral-pg

Grantor dc:publisher.institution

University of Strathclyde

Year dc:date.issued

2013

Author dc:creator

• Coombs, Gemma

DOI

10.48730/7kem-df95

Identifier

T13429

OAI identifier oai:identifier

oai:strathclyde:sb397828k