Scaleable oral dose formulations

Brammer, Elanor Michelle

Thesis

Scaleable oral dose formulations

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Creator

Brammer, Elanor Michelle

Rights statement

Strathclyde Thesis Copyright

Awarding institution

University of Strathclyde

Date of award

2023

Thesis identifier

T16541

Person Identifier (Local)

201385222

Qualification Level

Doctoral (Postgraduate)

Qualification Name

Doctor of Philosophy (PhD)

Department, School or Faculty

Strathclyde Institute of Pharmacy and Biomedical Sciences

Abstract

This thesis explores the manufacture of personalised medicine for solid oral dosage forms, with the main area of research focused on the use of Fused Filament Fabrication (FFF), a 3-dimensional printing (3DP) technique which utilises a polymer filament as feedstock. Two different techniques for the incorporation of a drug within this filament feedstock, solution loading and extrusion loading, are examined in order to investigate the applicability of this technique in the production of varying doses of carvedilol. The solution loading method is highlighted as having the potential to be beneficial when concerned with the manufacture of low dose drugs, whereas the extrusion loading method allows for higher dose drugs to be produced with greater overall dose variation. In terms of how these new dosage forms behave, the FFF 3DP technique lends itself to the production of tablets with sustained release characteristics, alteration of which is difficult to achieve even with the use of pharmaceutical disintegrants. Despite various attempts to alter this release, through the use of different additives or structural changes to the dosage forms, sustained release remains the mechanism by which any active pharmaceutical ingredient (API) will be released within the body. Carvedilol is currently marketed as both an immediate release and as a controlled release product. While investigation has concluded that immediate release is not achievable with this manufacturing method, this thesis demonstrates the production of sustained release dosage forms of carvedilol in a range of 7-101 mg, which exceeds the range of 10-80 mg currently available for the controlled release product. While this area of research is still in its infancy, this thesis provides an in-depth investigation into FFF as a manufacturing technique and acts as a starting point for the consideration of adopting this technique as a viable method of production in the pharmaceutical industry.

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