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Drug nanocrystals in the commercial pharmaceutical development process
1Pharmaceutical Development, Abbott GmbH & Co. KG, Knollstr. 50, 67061 Ludwigshafen am Rhein, Germany. janpeter.moeschwitzer@abbott.com
International Journal of Pharmaceutics
|September 25, 2012
Summary
Nanosizing techniques, like wet ball milling and high pressure homogenization, are crucial for developing poorly soluble drugs. Drug nanocrystals are now clinically proven, with six FDA-approved products demonstrating their effectiveness.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Drug Delivery
Background:
- Poorly soluble drugs present significant challenges in pharmaceutical development.
- Nanosizing is a key strategy to enhance the bioavailability and efficacy of these compounds.
- Particle size reduction techniques are vital for creating effective drug formulations.
Purpose of the Study:
- To review the advancements in nanosizing technologies for poorly soluble drugs.
- To highlight the industrial relevance and clinical success of drug nanocrystals.
- To discuss the versatility and broad applicability of nanosuspensions in drug development.
Main Methods:
- Focus on top-down nanosizing processes: wet ball milling and high pressure homogenization.
- Discuss the evolution and optimization of these industrial-scale techniques.
- Acknowledge alternative bottom-up and combination approaches.
Main Results:
- Industrial nanosizing processes have overcome initial challenges like abrasion and long processing times.
- Enhanced understanding of biopharmaceutical properties has improved in vivo success rates for drug nanocrystals.
- Six FDA-approved nanocrystal products validate the clinical effectiveness of this approach.
Conclusions:
- Nanosizing technology, particularly drug nanocrystals, is a versatile and essential platform for commercial drug development.
- Nanosuspensions are utilized across all stages of drug development, from milligram to production scale.
- Major pharmaceutical companies widely adopt drug nanocrystal formulation due to its proven potential.
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