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Micronization for formulation success

We understand client needs because we’ve been there ourselves. We know the importance of quickly modifying a formulation to achieve the exposure results you need. We provide formulation insight and work with your formulation development team to get the most out of micronization. We know the obstacles, challenges, and rewards of getting drug formulation right.

Micronization to improve drug exposures for better bioavailability

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  • Clients see as much as 40% improvements in bioavailability

  • Particle sizes are reduced from over 150 μm to less than 10 μm

  • Micronization works because the GI is inherently dynamic and as dissolution rates go up, more drug can be absorbed

  • For solubility limited drugs, rapid dissolution in the GI drives faster absorption, transit to the site of action, and overall improved exposures

Results with micronization:

Client achieves 40% improvement in exposures and creates successful extended release formulation

Team is able to create successful Phase 2 formulation with 25% increase in exposure, reducing COG’s

Increased specific surface area by 21X by Reducing particle size from 150µm to 7µm

Increased rate of dissolution by 20X through micronization

All of these while maintaining crystalline structure and chemical purity

How we think about formulation development:

Understand the molecule

Micronize to improve solubility

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- Spray drying

- Hot melt

- Nanomill

Pair the molecule with the right excipients /surfactants

Achieve rapid disintegration and dispersion

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Select processing methods that retain particle size benefits

Micronization is the cost-effective solution

Formulations are complex and costly, micronization is the most cost-effective solution available to improve bioavailability. Added benefit; micronization can help improve your formulation and intellectual property position.

Comparative costs of solubility improvement options

Particle Solutions Micronization Cost Sa

* Costs include significant analytical development, excipient compatibility and capital cost for wet parts

** New formulation is required to perform in vitro/vivo proof of concept

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