Production of API-loaded PLGA Nanoparticles for Drug Delivery Utilizing Microfluidic Technology
Production of API-loaded PLGA NPs
To meet the customer’s requirement for producing a minimum volume of API-loaded PLGA NPs, equivalent to 1000 doses for each potential nanoparticle product intended for in vivo studies, we utilized optimized conditions. By applying the fixed FRR at 3:1, TFR at 5 ml/min, and maintaining PLGA and drug concentrations at 2% and 0.5% (w/v), respectively, we effectively implemented a scaled-up production process for drug-loaded PLGA NPs. The pump system’s capacity was able to increase to 0.6 L/h, enabling the continuous manufacturing of nanoparticles carrying the drug in multi-liter quantities for pre-clinical testing. This approach ensures both cost-efficiency and the maintenance of high-quality NPs.
The journey was far from straightforward, as it presented a unique set of remarkable challenges.
Unique characteristics of the API
The client’s hydrophobic drug faced solubility challenges, complicating its transport into the body. Loading the drug within polymeric NPs was hindered by unknown properties and interactions with the polymer matrix. Selecting an ideal delivery system proved challenging; prior attempts with chitosan, hydrogel, and PEGylation were unsuccessful. Our proposal involved loading the drug into a PLGA matrix to create API-loaded PLGA NPs. We screened multiple PLGA polymers for the optimal candidate, utilizing our expertise in microfluidic technology for efficient testing.
Communicating the unpredictable nature of scientific research
As part of the research, we had many carefully planned, controlled, and optimized experiments that did not lead to positive outcomes. To effectively communicate these results to customers, we developed a documentation system and tracked our experiments meticulously. We also had biweekly meetings with customers to discuss the results promptly. When needed, we adjusted our experiment design, taking into account the new results, ensuring that we have the best chances to deliver the project, while adhering to the timeline and preserving the project’s integrity.
Delay of chemicals shipping
Once we embark on the project, availability of chemicals, especially novel APIs from customer is extremely important. However, cross-border conditioned shipping is very time-consuming and requires lots of attention to regulations and declaration. We had to forecast the use of chemicals from the beginning of the project and always maintained our stock at a high level. We also partnered with the most specialized, efficient forwarders to enhance transportation. This incurred additional costs for the project but help us keep the timeline and achieve the best results.