3D Printing as a Platform for Manufacturability Evaluation of Amorphous Solid Dispersions – Poster

See in the following the PhD research poster by Abdelazeez Mohamednour

1-Aim and Context of Work

Amorphous solid dispersions enhance the solubility of poorly water -soluble drugs. Manufacturing routes such as hot melt extrusion are used to formulate the ASD. However, the down stream processing of the wide array of physical forms of the resultant HME extrudates is a challenge. This requires an array of approaches to address the range of materials properties such as brittle, plastic, elastic etc. in order to transform the ASD formulation into aviable format for conversion into an OSD.

This work investigates a novel filament -free 3Dprinting approach developed at CMAC, where hot melt extrusion is directly coupled with printing to a viable dose form and overcome some of the processing challenges with HME. We also exemplify approaches to defining operating space by evaluating links between melt rheology and printability and its influences upon the mechanical properties and dissolution performance.

2-Research Challenges

• Existing routes to convert HME extrudates require configurable multi step processes to transform the extrudates into a granule, flake or powder format for conversion to an oral solid dose form .
• The direct HME to 3DP approach allows us to overcome these challenges by removal of the intermediate processes.
• Here we present current results which help define the operating space of anovel filament-free 3D printing system.
• Melt rheology and viscosity strongly influence printability, yet clear processing thresholds are not established.
• Direct extrusion-to -print stability (flow consistency, pressure fluctuations) can affect print quality .
• Printing performance requires systematic optimization of temperature, throughput, and print speed.

3-Defining Extrusion and 3D Printing Conditions via Phase Diagrams and Expected Dissolution Profiles

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4-Manufacturing – Removal of the difficult intermediate step filament to filament free

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5 – Results

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6 – Conclusion and Future Work

• The technolog has enabled the direct formation of viable dose forms that are not possible other means without multi step processing routes.
• Printability governed by viscosity, Printing speed and bed temperature.
• Speed and infill % control print quality and stability.
• Next to evaluate release and dissolution of these 3D-printed tablets.

See the full poster on 3D Printing as a Platform for Manufacturability Evaluation of Amorphous Solid Dispersions here

(click the picture to download the poster)

Source: Abdelazeez Mohamednour, Ecaterina Bordos, Elke Prasad, Daniel Markl, John Robertson, CMAC, CEDAR, an EPSRC Centre for Doctoral Training in Cyber Cyber-Physical Systems for Medicines Development and Manufacturing, University of Strathclyde, Glasgow, UK.

Poster: 3D Printing as a Platform for Manufacturability Evaluation of Amorphous Solid Dispersions