An Additive Manufacturing MicroFactory : overcoming brittle material failure and improving product performance through tablet microstructure control for an immediate release dose form
Prasad, Elke and Robertson, John and Halbert, Gavin W. (2024) An Additive Manufacturing MicroFactory : overcoming brittle material failure and improving product performance through tablet microstructure control for an immediate release dose form. Polymers, 16 (18). 2566. ISSN 2073-4360 (https://doi.org/10.3390/polym16182566)
Preview |
Text.
Filename: Prasad-etal-Polymers-2024-An-Additive-Manufacturing-MicroFactory.pdf
Final Published Version License: Download (1MB)| Preview |
Abstract
Additive manufacturing of pharmaceutical formulations offers advanced micro-structure control of oral solid dose (OSD) forms targeting not only customised dosing of an active pharmaceutical ingredient (API) but also custom-made drug release profiles. Traditionally, material extrusion 3D printing manufacturing was performed in a two-step manufacturing process via an intermediate feedstock filament. This process was often limited in the material space due to unsuitable (brittle) material properties, which required additional time to develop complex formulations to overcome. The objective of this study was to develop an additive manufacturing MicroFactory process to produce an immediate release (IR) OSD form containing 250 mg of mefenamic acid (MFA) with consistent drug release. In this study, we present a single-step additive manufacturing process employing a novel, filament-free melt extrusion 3D printer, the MicroFactory, to successfully print a previously ‘non-printable’ brittle Soluplus®-based formulation of MFA, resulting in targeted IR dissolution profiles. The physico-chemical properties of 3D printed MFA-Soluplus®-D-sorbitol formulation was characterised by thermal analysis, Fourier Transform Infrared spectroscopy (FTIR), and X-ray Diffraction Powder (XRPD) analysis, confirming the crystalline state of mefenamic acid as polymorphic form I. Oscillatory temperature and frequency rheology sweeps were related to the processability of the formulation in the MicroFactory. 3D printed, micro-structure controlled, OSDs showed good uniformity of mass and content and exhibited an IR profile with good consistency. Fitting a mathematical model to the dissolution data correlated rate parameters and release exponents with tablet porosity. This study illustrates how additive manufacturing via melt extrusion using this MicroFactory not only streamlines the manufacturing process (one-step vs. two-step) but also enables the processing of (brittle) pharmaceutical immediate-release polymers/polymer formulations, improving and facilitating targeted in vitro drug dissolution profiles.
ORCID iDs
Prasad, Elke ORCID: https://orcid.org/0000-0002-5412-9374, Robertson, John ORCID: https://orcid.org/0000-0002-2191-1319 and Halbert, Gavin W.;-
-
Item type: Article ID code: 90539 Dates: DateEvent11 September 2024Published27 August 2024Accepted18 July 2024SubmittedSubjects: Medicine > Pharmacy and materia medica > Pharmaceutical technology Department: Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
Technology and Innovation Centre > Continuous Manufacturing and Crystallisation (CMAC)Depositing user: Pure Administrator Date deposited: 11 Sep 2024 08:53 Last modified: 10 Oct 2024 06:58 Related URLs: URI: https://strathprints.strath.ac.uk/id/eprint/90539