Aston Particle Technologies (APT) has significantly expanded its in-house R&D capabilities by investing in two specially designed benchtop systems to prepare small quantities of blended pharmaceutical powders for use in its formulation development projects for pharmaceutical companies.
APT is already working with a number of large multinational pharmaceutical companies but the two new systems will allow it to further increase its commercialisation activities and the number and scale of development projects it can work on simultaneously. The new systems could also play a key role in helping to accelerate, for example, the development of new dry powder inhaler formulations for the treatment of asthma and COPD; novel ways to improve the delivery and potency of poorly water-soluble drugs; taste-masking solutions; or to improve the flowability of powders.
The new sample preparation systems have been specifically developed by automation consultancy GB Innomech (Innomech) to reproduce APT's unique one-step particle engineering technology on a small scale: to enable 'challenging' active pharmaceutical powders to be dry powder coated onto carrier particles. The systems can be used to prepare up to tens of grams of blended materials but use exactly the same process technology, conditions and recipe-based control system as the company's two kilogram pilot-scale production unit.
As soon as a development partner has then selected which formulations to progress, APT can immediately transfer the process conditions into its pilot-scale system to start producing the blended material in kilogram quantities for more extensive R&D studies.
"The new Innomech benchtop units will enable us to work at a smaller scale, on a larger number of commercial projects and to more closely align our formulation development activities with the needs of our pharmaceutical industry partners. As a result, we can also develop multiple prototype formulations and at an earlier stage when pharmaceutical companies have typically only got small quantities of key ingredients available," said Professor Afzal Mohammed, CTO and founder of APT.
One of the challenges when working with conventional powder blending technologies is that there is almost no correlation between small and large-scale equipment, which means most development work takes place on a larger scale. In comparison, APT has already demonstrated the scalability of its powder coating process which could lead to significant savings in development timescales and costs, as well as easier regulatory compliance.
For example: the technology can be used to prepare small quantities for proof of principle studies before a pharmaceutical company decides to buy in bulk quantities or to scale up its synthesis of specific ingredients. Development partners can also be fully confident that when they do need larger quantities of blended formulations, the quality and composition will be identical to the material used within their earlier studies.
Innomech took around five months to design and build the two new benchtop system for APT and also developed the company's pilot-scale unit that was delivered in 2017.