Kapilkumar Vithani1, Alvaro Goyanes2, Vincent Jannin3,4, Abdul W Basit2, Simon Gaisford2, Ben J Boyd5,6. 1. Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University (Parkville Campus), Parkville, Victoria, 3052, Australia. 2. UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK. 3. Gattefossé SAS, 36 Chemin de Genas, 69804, Saint-Priest, France. 4. Lonza Pharma & Biotech, Parc d'Innovation, Rue Tobias Stimmer - BP 30442, 67412, Illkirch, Graffenstaden, France. 5. Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University (Parkville Campus), Parkville, Victoria, 3052, Australia. ben.boyd@monash.edu. 6. ARC Centre of Excellence in Convergent Bio-Nano Science and Technology, Monash University (Parkville Campus), Parkville, Victoria, 3052, Australia. ben.boyd@monash.edu.
Abstract
PURPOSE: The use of three-dimensional printing (3DP) in the development of pharmaceutical dosage forms is growing rapidly. However, the research is almost exclusively focussed on polymer-based systems with very little reported on 3D printing of lipid-based formulations. Thus, the aim of the work was to explore the feasibility of 3DP technology to prepare solid lipid-based formulations. Here, 3DP was applied for the preparation of solid self-microemulsifying drug delivery systems (S-SMEDDS) with defined surface area to volume (SA/V) ratios. METHODS: The S-SMEDDS formulations, comprised of Gelucire® 44/14, Gelucire® 48/16 and Kolliphor® P 188 were loaded with fenofibrate or cinnarizine as model drugs. The formulations were printed into four geometrical shapes - cylindrical, prism, cube and torus, and compared to a control cube manually prepared from bulk formulation. RESULTS: The printing process was not significantly affected by the presence of the model drugs. The as-printed S-SMEDDS formulations were characterised using differential scanning calorimetry and wide-angle X-ray scattering. The kinetics of dispersion depended on the SA/V ratio values. The digestion process was affected by the initial geometry of the dosage form by virtue of the kinetics of dispersion of the dosage forms into the digestion medium. CONCLUSIONS: This proof of concept study has demonstrated the potential of 3DP for the development of customised S-SMEDDS formulations without the need for an additional carrier or additive and with optimisation could elaborate a new class of dosage forms based on 3D printed lipids. Graphical abstract Lipid based formulations were 3D printed in various shapes to control the surface are to volume ratio and consequently the kinetics of dispersion.
PURPOSE: The use of three-dimensional printing (3DP) in the development of pharmaceutical dosage forms is growing rapidly. However, the research is almost exclusively focussed on polymer-based systems with very little reported on 3D printing of lipid-based formulations. Thus, the aim of the work was to explore the feasibility of 3DP technology to prepare solid lipid-based formulations. Here, 3DP was applied for the preparation of solid self-microemulsifying drug delivery systems (S-SMEDDS) with defined surface area to volume (SA/V) ratios. METHODS: The S-SMEDDS formulations, comprised of Gelucire® 44/14, Gelucire® 48/16 and Kolliphor® P 188 were loaded with fenofibrate or cinnarizine as model drugs. The formulations were printed into four geometrical shapes - cylindrical, prism, cube and torus, and compared to a control cube manually prepared from bulk formulation. RESULTS: The printing process was not significantly affected by the presence of the model drugs. The as-printed S-SMEDDS formulations were characterised using differential scanning calorimetry and wide-angle X-ray scattering. The kinetics of dispersion depended on the SA/V ratio values. The digestion process was affected by the initial geometry of the dosage form by virtue of the kinetics of dispersion of the dosage forms into the digestion medium. CONCLUSIONS: This proof of concept study has demonstrated the potential of 3DP for the development of customised S-SMEDDS formulations without the need for an additional carrier or additive and with optimisation could elaborate a new class of dosage forms based on 3D printed lipids. Graphical abstract Lipid based formulations were 3D printed in various shapes to control the surface are to volume ratio and consequently the kinetics of dispersion.
Entities:
Keywords:
3D printing; geometrical shapes; kinetics of dispersion and digestion; solid self-microemulsifying drug delivery system (S-SMEDDS); surface area to volume ratio value
Authors: Nour Allahham; Fabrizio Fina; Carmen Marcuta; Lilia Kraschew; Wolfgang Mohr; Simon Gaisford; Abdul W Basit; Alvaro Goyanes Journal: Pharmaceutics Date: 2020-01-30 Impact factor: 6.321
Authors: Mohammed S Algahtani; Abdul Aleem Mohammed; Javed Ahmad; M M Abdullah; Ehab Saleh Journal: Pharmaceutics Date: 2021-06-30 Impact factor: 6.321