What is Personalised Medicine?
Imagine your medicine being tailored to your exact needs based on your gender, size, genetics and desired drug form.
The traditional medical approach comprises a ‘one-size-fits-all’ application of drugs. This does not consider interpatient variability and, has long been known, may result in significantly different therapeutic outcomes among patients. The ability to provide the optimum dosage and apply an ‘individual’ approach to patients has gained increasing interest due to ongoing development in the field of human genome research and new potential manufacturing technologies, i.e. 3D printing. Providing genetic information on an individual patient level improves decision-making regarding the right active pharmaceutical ingredient, dose, and time required for a specific patient resulting in fewer adverse effects and superior treatment outcomes.
In addition to making medical decisions based on patient data and lifestyle factors, personalised medicine can involve taking into account the personal preferences of a specific patient. A solid oral dosage form can be tailored according to personal preferences related to e.g., size, colour, shape, and taste, which can be particularly important for acceptability among children and patients with swallowing conditions. To date, the administered dose is typically tailored by manipulation of the marketed formulation by splitting or crushing tablets into smaller pieces or opening capsules. However, such manipulation of solid oral dosage forms is not accurate and may lead to day-to-day variability of the administered dose and thus result in undesired over- or under-dosing. Manipulations of solid oral dosage forms can also alter the properties of the dosage form with potentially dangerous outcomes such as dose dumping of a sustained release dosage form or destroying the pH-sensitive coating resulting in release of the active drug at the wrong site in the gastrointestinal tract.
Conventional fixed procedure and process parameters e.g., tableting, involve processes that are well understood and have well-established regulatory pathways but lack the flexibility needed for manufacturing personalised dosage. The U.S. Food and Drug Administration (FDA) are encouraging pharmaceutical companies to implement modern and innovative manufacturing technologies and processes, such as printing technologies, which are flexible and enable production of advanced dosage forms with high accuracy, to solve this unmet need. The ability to manufacture personalised dosage forms is forecasted to advance treatment outcomes by enabling patient-tailored medicines that have improved efficacy, safety, compliance, and accessibility.
How can 3D printing help?
3D printing enables production of innovative and complex solid oral dosage forms, drug delivery devices, and medical devices with regards to the geometrical shape and complex inner structures that are not easy or impossible to attain with conventional manufacturing methods. The potential ease of manipulation of the printed solid dosage form makes 3D printing attractive for use in personalised medicine and would allow tailored solid oral dosage forms to be produced on-demand, in small volumes, with a limitless number of product designs and various personalisation features, e.g., patient-tailored drug content, drug release profile, and customized functionality, according to the patients’ needs. This may result in improved treatment outcomes lowering the societal burden associated with poor treatment outcomes that are costly for society.
How can Texture Analysis help?
Different printing technologies exist, e.g. fused deposition modelling, semisolid extrusion 3D printing, inkjet printing which require vastly different properties of the starting materials, involving solid, semisolid, and liquid states of matter. Each one will potentially produce a solid dosage form that has different mechanical properties that will ultimately affect the effectiveness of the drug. For a medicine to be effective and safe the active pharmaceutical ingredient (API) needs to be delivered in a desired, safe, and unvarying way to the intended target in the body. Pharmaceutical development aims to define the design space, specifications, and manufacturing requirements to achieve this. This will, amongst other vital measurements, need extensive knowledge of the resulting mechanical properties of the 3D printed forms which will need to be measured in order to ensure the medicine will be effective on the basis of the contribution of properties to correct tablet breakdown at the intended target.
How texture of 3D printed pharmaceuticals can be measured
Materials for printing should have adequate rheological properties that can be easily extruded and maintain their shape. Any materials that are proposed for 3D printing will require ‘printability’ testing to ensure they possess the correct rheological properties or consistency. Formulations will need to be assessed for their extrudability and the resulting printed products measured by way of a compression test to ensure mechanical expectations are matched. The fracture and bending characteristics of a tablet may also be a necessary assessment.
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| Typical compression, extrusion and bending tests on a Texture Analyser |
Here are specific research examples of where texture analysis has already been applied in this way:
Printing Technologies for Personalization of Dosage Forms
Personalised Tasted Masked Chewable 3D Printed Fruit-Chews for Paediatric Patients
Development of a 3D-Printed Dosing Platform to Aid in Zolpidem Withdrawal Therapy
Development of 3D printable bioresorbable coronary artery stents: A virtual testing approach
Printability of pharmaceutical polymers in FDM 3D printers
How a Texture Analyser can assess 3D printer base powder flowability
Texture Analysis can also be put to use at other stages in the 3D printing process, not just for the measurement of final product properties. For example, the properties of the base powder used in Selective Laser Sintering affect the sintering process as well as the properties of the final product. Powder flow is one of these properties. As each new layer of powder is swept onto the sintering bed, the layer should be uniform and of the correct thickness and distribution. A Powder Flow Analyser (PFA) is a very useful add-on to a Plus Connect Texture Analyser to help measure these flow properties.
The PFA proves an accurate and reliable method of measuring the flow characteristics of dry and wet powders, with capability to measure cohesion, caking and speed flow dependence as well as bulk density and other properties.
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| The Powder Flow Analyser on the TA.XTplusC Texture Analyser |
As the benefits of personalised medicine are becoming evident, the conventional way of developing and manufacturing dosage forms needs to be adapted to moreover consider the personalisation aspect. This requires a paradigm shift from manufacturing large batches with a fixed drug content to manufacturing processes that allows for easy alteration of the dosage form. This is where Texture Analysis needs to be employed.
To read more about how texture analysis can be applied to 3D printing, pharmaceutical product property measurement and assessment of powder flow, request the following articles:
Texture Analysis: Its Importance for 3D Printed Medical Materials
Measuring Powder and Granule Properties to anticipate problems
There is a Texture Analysis test for virtually any physical property. Contact Stable Micro Systems today to learn more about our full range of solutions.
For more information on how to measure texture, please visit the Texture Analysis Properties section on our website.
The TA.XTplusC texture analyser is part of a family of texture analysis instruments and equipment from Stable Micro Systems. An extensive portfolio of specialist attachments is available to measure and analyse the textural properties of a huge range of food products. Our technical experts can also custom design instrument fixtures according to individual specifications.
No-one understands texture analysis like we do!
Get in touch to discuss your specific test requirements
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