Digital Design Accelerator
Digital innovation brings better tablets to market faster
The challenge
Pharmaceutical products are precisely crafted packages. Active pharmaceutical ingredients (APIs) require careful formulation with other compounds to ensure tablets are palatable and safe. Developing a repeatable and controlled process that consistently produces high-quality medicines can take a significant amount of time.
Now a consortium involving CPI has created a revolutionary smart platform to improve the design and development of new pharmaceuticals and formulations. It takes data from across pharmaceutical development functions so it can be searched, visualised, modelled and analysed to accelerate pharmaceutical development.
With funding from Innovate UK, AstraZeneca led the Digital Design Accelerator Platform (DDAP) project to create this powerful new industrial digital technology.
Our complex particles team devised methods to predict the physical stability of formulation powders, and the chemical stability of APIs inside tablets. The model, validated experimentally, supports a tool that predicts how changes in drug materials and APIs affect downstream manufacturability, stability and product performance (and hence clinical outcomes).
The project also involved Cambridge Crystallographic Data Centre, GSK, University of Leeds, Perceptive Engineering, Pfizer, Siemens Process Systems Engineering (formerly PSE), University of Sheffield, and University of Strathclyde.
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1675346370&s=f4d7194c25510917b1fd7d7e1ae7a39a 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1675346370&s=d013e54d553b035d79a1cbff6123542b 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1675346370&s=73cbd41872de5afc618743e491bdab9f 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1675346370&s=bb4b09f0b43c252478c6f8b3c533291e 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1675346370&s=78b567bef10efb27699d6cfbc5dc37f1 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1675346370&s=436fa0859f50678417dad8466f8e759d 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/AdobeStock_182376038_2023-02-02-135930_emlf.jpeg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1675346370&s=0ca6125f5194040c24e2680ce42bf814 960w)
““With digital tools we can build in operational excellence right from the start of pharmaceutical development, improve product robustness, and drive more efficient manufacturing processes to deliver more medicines to more patients, more quickly.””
![Sophie Bailes Sophie Bailes](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/Sophie-Bailes.jpg?w=100&h=100&q=60&fm=jpg&fit=crop&dm=1675291800&s=18fe9789f21c2c1c5298701ff3f07569)
How CPI helped
- Studies of moisture-induced degradation of molecular structure and disproportionation of salt molecules in powders.
- New model developed to predict chemical stability of APIs inside tablets.
- New model to evaluate physical stability of API-formulation powders.
- Experimental validation of models using powder X‑ray diffraction and dynamic vapour sorption.
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1675339459&s=29c768c648d1e579cc857da4e676248a 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1675339459&s=3ec8527688a7d2f1dbe9ff8556203bbe 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1675339459&s=6163532073fc14a25cc7c92f67f92478 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1675339459&s=bf6ffec6994d7647017b6336ec728580 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1675339459&s=928d02782fc365f6a09a52924823d8aa 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1675339459&s=d4dc85775f14c0f64ac481c9da102c6f 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/190208cpiiRAW_041-JPEG.jpeg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1675339459&s=9443a98d2e50997f43c1681a54ceb177 960w)
Achievements
- Identified gaps in existing mechanistic models for tablet stability.
- Improved the accuracy and applicability of previously published models.
- Models coded for integration into common software packages, such as gPROMS and MATLAB.
- Contributed to creation of a Digital Risk Assessment tool that predicts how changes in drug materials and APIs affect downstream manufacturability, stability and product performance.
- Roadmap published for future development of industrial digital technologies in the pharma sector.
Impact
The DDAP project accelerates the pharma industry’s transition to the full digitalisation of pharmaceutical product and process design, modelling, and process control. Our collaboration has supplied top-flight pharma companies with important new predictive models to improve and speed up formulation processes.
The adoption of such predictive tools will support more consistent product quality, reduce waste and assist faster product development.
In the face of health crises, digitalisation enables the pharma sector to provide a better, faster response to existing and emerging diseases. Platform technologies strengthen global supply chains and make clinical trials more efficient; candidate products are more ‘trial-ready’, and manufacturers can scale-up production faster. Overall, digitalisation leads to better medicines that can reach patients more quickly.
Partners
![Cambridge Crystallographic Data Centre](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/CCDC_cambridge-bran_trans.png?w=400&h=98&q=100&fm=png&fit=crop&dm=1675246092&s=cef660d160828c6bf335f71f5fe25f20)
![GSK](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/GSK-png.png?w=120&h=84&q=100&fm=png&fit=crop&dm=1675332063&s=2a84d7ab67bf1c75ab98a8c958accf7d)
![Perceptive Engineering](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/PE-png.png?w=120&h=120&q=100&fm=png&fit=crop&dm=1675332283&s=8628b2111c09348ef7f8a6f9872573d5)
![Siemens Process Systems Engineering](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/PSE-png.png?w=120&h=120&q=100&fm=png&fit=crop&dm=1675334204&s=7de72fe9745b187842bc6f8db01b8129)
![University of Leeds](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/University-of-Leeds-logo.jpg?w=400&h=114&q=100&fm=png&fit=crop&dm=1675246160&s=4f8aab7ea46c96ef7b7b3cd6074ac476)
![University of Sheffield](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/UOSheffield-Logo_Primary_Violet_RGB.png?w=400&h=121&q=100&fm=png&fit=crop&dm=1675246286&s=5a27018e33681101f9c7a75e13b892ce)
![University of Strathclyde](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/University_of_Strathclyde_Glasgow_logo_C-png.png?w=400&h=236&q=100&fm=png&fit=crop&dm=1675332717&s=ff7f1164dbb783cbf68fe74cae234111)
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