Polymer Nanoparticles

Ideal Technology for Producing Polymer Nanoparticles

Your Challenges

Useful in targeted delivery of drug molecules to improve therapeutic efficacy it is important to be able to control the manufacturing process and scale up carefully. 

Our Experience

Let us use our collective 90 years of applications development and machine engineering experience to help drive your product to market as quickly as possible.

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How we can help

Our technology achieves reproducible high shear forces to control particle size giving polymer nanoparticles the ability to be terminally sterilized via filtration and controlled release.

Our Approach

Microfluidizer® processors are designed to be simple to use and clean with the option of conforming to cGMP requirements. 

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In detail

Polymer Nanoparticles

Biodegradable polymer nanoparticles are an innovative drug delivery system, offering a number of benefits:

  • Delivery of a combination of various therapeutic ingredients

  • Ability to include targeting moieties

  • Protecting active ingredients from degradation to ensure efficacy

  • Control of the release of ingredients

  • Particles small enough to be sterilized through filtration

Listen to Dhruba J. Bharali, Ph.D discuss the process development for the manufacture of nanotetrac.

WEBINAR  Listen to the webinar where Dhruba J Bharali Ph.D  discusses manufacture of nanotetrac  for pharmaceutical applications  > click here

Key steps in the formulation of Polymer Nanoparticles:

Key Formulation stages

  • Aqueous phase: water + surfactant are combined

  • Oil phase:  the polymeric and other hydrophobic ingredients (such as actives, contrast agents, etc.) are dissolved in the water immiscible solvent.

Factors to be considered in selecting the solvent:

  • Water miscibility
  • Boiling point
  • Toxicity
  • Active Pharmaceutical Ingredients (APIs)
  • Diagnostic ingredients (such as contrast enhancers)
  • Other ingredients (such as para-magnetic particles, metal oxides, etc.)

Read more on polymer nanoparticle preparation

Key steps in the manufacture and extraction process:

Processing steps

  • Prepare the separate oil & aqueous phases

  • Add oil to the water phase

  • Mix using a rotor-stator motor to create a coarse emulsion as a stable pre-mix

  • Process the pre-mix using a Microfluidizer® high shear homogenizer - in selecting the model, consider the critical processing parameters of chamber type, processing pressure, temperature and number of passes

Solvent Extraction process:

  • Allow the solvent to evaporate in a hood while mixing

OR

 

  • Use a solvent-exchange technique, such as a separator funnel or rotary-evaporator

Read more on polymer nanoparticle preparation

Microfluidizer® Processor manufacturing produces on-target particles:

Particle size analysis is often used to evaluate polymer nanoparticles.

Utilizing specific analytical techniques, including dynamic light scattering, optical microscopy, and SEM or TEM, we have found that Microfluidizer® technology is able to reduce polymer droplet size significantly after several passes.

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Watch our webinar on Microfluidizer: A Tool for Process Development to Manufacture Nanotetrac

Resources

Webinar

Microfluidizer: A Tool for Process Development to Manufacture Nanotetrac

WEBINAR Listen to the webinar where Dhruba J Bharali Ph.D  discusses manufacture of nanotetrac  for pharmaceutical applications > click here