Knowledge Base

Recorded Webinar: Learn how to encapsulate hydrophilic API in PLGA particles

Description

This webinar introduces you to Dolomite’s approach towards the encapsulation of hydrophilic active pharmaceutical ingredients (API) in PLGA micro- and nanoparticles. It’s a practical session exploring different methodologies of microfluidics technology and highlighting the benefits over traditional batch methods. By the end of the session, you’ll not only see the benefits but also realise how you can easily validate and then scale-up production with Dolomite..

Questions and Answers

1. For Methodology No. 2 and a 100 µ chip, what is the maximal tolerable API particle size in the DCM phase?

We would recommend up to 5 µm, but larger sizes are tolerable too.

2. To which extent could you use a water miscible solvent (e.g. DMSO) to the DCM to help solubilizing API?

You could use any water miscible solvent – our methodologies are verified using acetone, but we are not limited to this specific solvent.

3. Can these settings be compliant with GMP? Up to what volumes of production?

The equipment could be used in GMP process. Currently the equipment in not GMP certified, but we are working towards it.

4. It’s mentioned that the PLGA concentration that was used is 0.5-2%, do you achieve NPS within the size of 50 nm at the lowest concentration (0.5%) or regardless the PLGA concentration you can go to 50 nm?

No, the PLGA concentration is not the only parameter that controls the particle size, but it is one of the influencing parameters. We can advise on the application specific concentration after reviewing all aspects your requirements.

5. Is it possible to get NPS in the range of 10-50 nm?

Yes, we have a mechanism to do so using our setups, but 50-800 nm range is verified and reliable.

6. What is the biggest Telos system you could arrange?

Each chip has 7 junctions and we can put together 10 slots into the ‘cassette’. This totals to 70 junctions running in one process. Of course, you can use multiple systems simultaneously.