The aim of the event was to develop a pediatric formulation, from prototype to production scale. Live demonstrations from the Kilian laboratory in Cologne were complemented by scientific presentations on the subject of formulation and tableting.
Romaco Kilian recently got together with BASF to hold a 2-day workshop on tablet development with digital tools. Around 50 people, mainly from the pharmaceutical industry, accepted the invitation to Cologne.
They were treated there to an advanced course all about galenics and tableting and specifically targeted at employees in R&D departments or in specialised laboratories.
The aim was to design an ibuprofen 100 mg orodispersible tablet for paediatric use in just 2 days. This involved working through all of the development steps from characterisation of the API and selection of the ingredients to tableting the prototype and upscaling to production.
Digital workshop concept
As well as witnessing practical research work, the participants also listened to a series of scientific presentations, among other things on software-assisted formulation development, excipient selection and powder analysis plus orodispersible tablet properties.
Parallel to the theoretical part, a live link allowed attendees to watch the compression tests taking place in KiTech, Romaco Kilian’s tableting laboratory. The subsequent analysis of the measurement data with ZoomLab, BASF’s virtual pharmaceutical assistant, was likewise broadcast live.
“The novel workshop concept was very well received by our audience,” reported Dr Carola Hanl, KiTech Laboratory Manager at Romaco Kilian.
“Thanks to the innovative digital tools for both galenics and tableting, our guests were enabled to participate directly in our research project, where we developed a tablet all the way from the formulation through the prototype to production scale, all in full view."
"We demonstrated the process using the example of a pediatric ibuprofen orodispersible tablet, which was specially tailored to the requirements of the age group in terms of dosage amount and form.”
Formulation and tableting are child’s play
BASF Pharma Solutions supports research-based pharmaceutical manufacturers in the development of their products with ZoomLab, a scientifically proven digital tool that is designed to instantly predict formulations and overcome other formulation challenges.
The formulation can then be tested and the first product samples produced and evaluated. New formulations can thus be completed in a very short time.
The data fed to ZoomLab during the workshop at Kilian was collected live from the compression tests using Romaco Kilian’s KTP 1X laboratory press.
The formulation was successively revised and optimized on the basis of these measurement results. The single-stroke press is tasked with developing the ideal compression force/hardness profile for the desired tablet design, taking account of the different ingredients.
In this case, a biplane ibuprofen orodispersible tablet in 11.28 mm format with a 9 mm flat facet was the goal. Orange and vanilla flavours were added to mask the taste of the children’s medicine.
The challenge here was to come up with an orodispersible tablet that was as porous as possible, so that it dissolved quickly in water for ingestion. At the same time, it had to be compressed sufficiently hard to ensure efficient handling and packaging.
Smart tableting
Thanks to its highly automated compression studies, the KTP 1X laboratory press only needs a few test series to deliver meaningful results when characterising a formulation.
This versatile R&D press is moreover capable of replicating any standard rotary press, making it significantly easier to conduct scale-up trials.
The positive outcome of the production-scale tableting trials on the KTP 720X double-sided rotary press, which wound up the joint Romaco Kilian and BASF workshop in Cologne at the end of November 2023, was only logical.
“The response to our workshop was overwhelming,” emphasised Jens Carstens, Managing Director of Romaco Kilian. “In collaboration with BASF, we succeeded in designing a blueprint for pharmaceutical producers’ day-to-day development work and underpinned this model with well-founded scientific data."
|I’d like to express my sincere thanks to the speakers from BASF and Kilian as well as to everyone who worked so hard behind the scenes – not forgetting our guests, who enriched the event tremendously with their expert knowledge and wealth of experience.”
