Development of a rapid tooling injection moulding process for the production of pharmaceutical oral solid dosage forms with surface micro-features

Student thesis: Doctoral Thesis

Abstract

The overarching aim of this research was to develop a novel manufacturing process for the production of pharmaceutical dosage forms with accurate and precise surface micro-features. A novel method for the manufacture of oral solid dosage forms was developed by coupling stereolithography additive manufacture with injection moulding in a process known as Rapid Tooling Injection Moulding (RTIM). An assessment of a number of materials for the stereolithography process was performed, with the essential material properties for success in RTIM determined. From this study, a workflow was generated detailing the critical material properties to use stereolithography in conjunction with injection moulding and how to assess a new material for its suitability. A number of pharmaceutical polymer-based formulations were trialled in the RTIM process. A better understanding of the limitations of this technique was obtained and a number of oral solid dosage forms comprising surface micro-features were produced. The accuracy and precision of the dosage forms produced was measured, including the surface micro-features. Comparisons are made to similar manufacturing techniques in terms of the accuracy and precision of the dosage forms produced. Finally, paracetamol loaded polymeric formulations with varying specific surface areas were produced and the resulting drug release profiles captured. The accuracy and precision of the dosage forms produced was measured and the actual specific surface area was calculated. The RTIM process was capable of producing accurate and precise dosage forms in a variety of pharmaceutical polymeric materials. The drug release profiles were able to be modified for some formulations via altering the specific surface area of the tablets indicating that fine-tuning of the drug release profiles can be obtained using this manufacturing process. From this, a workflow was developed for the alteration of a drug release profile for a given formulation via modification of the specific surface area. The future applications of the RTIM method described in this research include its use as a direct manufacturing method for low production runs of pharmaceutical tablets. Additionally, the method can be utilised as a development tool to aid in the determination of the required tablet geometry for a desired drug release amongst other applications.
Date of Award1 Jan 2022
Original languageEnglish
Awarding Institution
  • University Of Strathclyde
SponsorsUniversity of Strathclyde & EPSRC (Engineering and Physical Sciences Research Council)
SupervisorDaniel Markl (Supervisor) & Joop Ter Horst (Supervisor)

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