Thesis
Development of a rapid tooling injection moulding process for the production of pharmaceutical oral solid dosage forms with surface micro-features
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- Awarding institution
- University of Strathclyde
- Date of award
- 2021
- Thesis identifier
- T16112
- Person Identifier (Local)
- 201869398
- Qualification Level
- Qualification Name
- Department, School or Faculty
- Abstract
- The overarching aim of this research was to develop a novel manufacturing processfor the production of pharmaceutical dosage forms with accurate and precise surfacemicro-features.A novel method for the manufacture of oral solid dosage forms was developed bycoupling stereolithography additive manufacture with injection moulding in a processknown as Rapid Tooling Injection Moulding (RTIM). An assessment of a number ofmaterials for the stereolithography process was performed, with the essential materialproperties for success in RTIM determined. From this study, a workflow was generateddetailing the critical material properties to use stereolithography in conjunction withinjection moulding and how to assess a new material for its suitability.A number of pharmaceutical polymer-based formulations were trialled in the RTIMprocess. A better understanding of the limitations of this technique was obtained anda number of oral solid dosage forms comprising surface micro-features were produced.The accuracy and precision of the dosage forms produced was measured, including thesurface micro-features. Comparisons are made to similar manufacturing techniques interms of the accuracy and precision of the dosage forms produced.Finally, paracetamol loaded polymeric formulations with varying specific surfaceareas were produced and the resulting drug release profiles captured. The accuracyand precision of the dosage forms produced was measured and the actual specific surfacearea was calculated. The RTIM process was capable of producing accurate andprecise dosage forms in a variety of pharmaceutical polymeric materials. The drugrelease profiles were able to be modified for some formulations via altering the specificsurface area of the tablets indicating that fine-tuning of the drug release profiles can beobtained using this manufacturing process. From this, a workflow was developed forthe alteration of a drug release profile for a given formulation via modification of thespecific surface area.The future applications of the RTIM method described in this research includeits use as a direct manufacturing method for low production runs of pharmaceuticaltablets. Additionally, the method can be utilised as a development tool to aid in thedetermination of the required tablet geometry for a desired drug release amongst otherapplications.
- Advisor / supervisor
- Markl, Daniel
- Resource Type
- DOI
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