Up-scaling the production of novel spherical lactose particles for potential use in dry powder inhalers

Spherical lactose particles have successfully been produced on a small scale
The current process of manufacturing in our lab is by a batch-to-batch method, which would be unsuitable for upscaling in any meaningful way. One of the main challenges to the current batch-to-batch production method is variability. The partner organisation (Croda) has expressed interest in the study of up-scaling as this would allow production in larger quantities. This was therefore outsourced to an external company (Upperton Pharma) in Nottingham. Here, the spray drying method was identified as a potential methodology for up-scaling purposes. This however has been fraught with several challenges predominately around processing and particle size growth.

The initial part of this project would therefore be spent conducting controlled tests to quantify the impact of variation in the current methodology. Once a defined method is finalised, the project would move on to other production methods for up-scaling. The project would seek to eliminate the challenges associated with the spray drying process as experienced previously to make this continuous manufacturing process which greatly reduces variability between batches. The University (School of Applied Sciences) has recently acquired an improved spray-dryer that can work with the solvents required in this project. The PI and Co-I already have the training and experience required to operate the equipment.

Another key aspect of this project is the testing of particles upon manufacture. Due to the size of the particles an imaging technique known as scanning electron microscopy (SEM) is required. The University has recently acquired a new microscope of this type, which is situated in the School of Computing and Engineering. Success in this project will rely on working closely with our colleagues in the School of Computing and Engineering to image the particles to tune the production method accordingly. The PI and Co-I both have experience in using microscopes of this type, although formal training on this new equipment will be required. Arrangements are already in place for this training and time scales are to be agreed if grant application is successful.

Once a feasible method of production is agreed on, the last stage of the project will be the use of equipment in the pilot plant for mass production. The partner organisation has already provided funding for this part of the project to ensure success. At this stage, the PI and Co-I will seek to embed their knowledge gained at the University to significantly up-scale the method at this industrial setting.